Diarrhea, Gastrointestinal Complications, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
diarrhea, gastrointestinal complications, unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy. PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy.
Detailed description
OBJECTIVES: Primary * To determine whether sulfasalazine is effective in reducing the acute treatment-related diarrhea in patients receiving pelvic radiotherapy as measured by NCI CTC v4.0 in patients receiving pelvic external-beam radiotherapy as adjuvant or primary treatment for malignancy. Secondary * To determine whether sulfasalazine can reduce chronic treatment-related bowel dysfunction following completion of therapy. * To determine whether sulfasalazine causes any toxicity in this situation. Tertiary * To bank blood products for future studies, as part of ongoing research for NCCTG studies (Mayo Clinic Rochester only). (Translational) OUTLINE: This is a multicenter study. Patients are stratified according to history of anterior resection of the rectum (yes vs no); total planned cumulative dosing, including boost fields of external-beam radiotherapy (4500-5350 cGy vs \> 5350 cGy); and concurrent radiosensitizing fluorouracil, capecitabine, or oxaliplatin (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral sulfasalazine twice daily during radiotherapy\* and for 4 weeks after completion of radiotherapy. * Arm II: Patients receive oral placebo twice daily during radiotherapy\* and for 4 weeks after completion of radiotherapy. NOTE: \*Patients must start study treatment by the third radiotherapy fraction. Patients may undergo blood sample collection at baseline and then weekly during radiotherapy. All patients complete quality of life and bowel function questionnaires at baseline, weekly during radiotherapy, and at 6 weeks after completion of radiotherapy. After completion of radiotherapy, patients are followed up at 6 weeks and at 12 and 24 months.
Interventions
DRUGsulfasalazine
Given orally
OTHERplacebo
Given orally
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of cancer that supports the use of radiotherapy to the pelvis * No current or prior metastases beyond pelvic regional lymph nodes * Planning to receive a course of continuous definitive or adjuvant external-beam radiotherapy to a minimum dose of 4500 cGy with or without fluorouracil, capecitabine, or oxaliplatin * Planned course of pelvic radiotherapy must fall within the following parameters: * Pelvis must be encompassed by the planned radiotherapy fields * Superior border may not lie superior to the L4-5 interspace and may not be inferior to the most inferior aspect of the sacroiliac joints * Portions of the rectum may have special blocking, depending upon disease site * Total planned dose to the central axis midplane (for AP-PA parallel opposed fields) or isocenter (for 3- or 4-field techniques) for the pelvic field must lie between 4500-5300 cGy (inclusive)\* * Subsequent to completion of treatment to the pelvic field, a boost to primary tumor or tumor bed may be planned * Planned treatment is to be given 4-5 times per week on a one-treatment-per-day basis * Daily dose (specified at central axis midplane or at isocenter for multi-field techniques) must lie between 170-210 cGy (inclusive) per day\* * NOTE: \*For institutions that do not use midplane or isocenter as the point for specification of dose, it will be necessary to determine the dose according to the methods specified above in order to determine patient eligibility. * No perineal irradiation planned (e.g., anal cancer patients, patients who have had an abdominal-perineal resection) * No brachytherapy planned before the completion of all external-beam radiotherapy * No planned split-course radiotherapy PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 6 months * Hemoglobin ≥ 10.0 g/dL * Leukocytes ≥ 3,500/mm\^3 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 1.5 times upper limit of normal (ULN) * AST ≤ 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing to provide blood specimens as required by the study (Mayo Clinic Rochester patients only) * Able to complete questionnaires alone or with assistance * No history of inflammatory bowel disease * No history of gastrointestinal or genitourinary obstruction or porphyria * No history of G6PD deficiency * No history of irritable bowel syndrome * No history of blood dyscrasia * No history of severe allergies or asthma * No history of hepatic or renal disease * No diarrhea ≥ grade 3, rectal bleeding, abdominal cramping, or incontinence of stool within the past week * No medical condition that may interfere with the ability to receive study treatment * No known allergy to sulfasalazine, sulfa medications, salicylates, or any known component of drug formulation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior pelvic radiotherapy * No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum * No planned use of leucovorin or cytotoxic chemotherapeutic agents concurrent with radiotherapy (except for fluorouracil, capecitabine, or oxaliplatin) * No other concurrent sulfasalazine * No concurrent digoxin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | During radiation therapy and up to 6 weeks post radiation therapy | The primary endpoint for this study is the maximal severity of diarrhea toxicity. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening as measured by the CTCAE version 4.0. Assessments were recorded during the course of RT and for 6 weeks following RT. The table below represents the worst graded diarrhea for each patient. A two-sided Wilcoxon rank-sum test will be used to test the equality of the distributions of maximum diarrhea severity grades between the two treatment arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT | During radiation therapy and up to 6 weeks post radiation therapy | For each patient, an Area Under the Curve (AUC) summary statistic will be calculated taking into account the individual severity of diarrhea toxicity over time. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. The curve was constructed using weekly assessments during and after RT. A separate analysis was done during the course of RT and every week for 6 weeks following RT. |
| Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | During radiation therapy and up to 6 weeks post radiation therapy | Tenesmus, Abdominal pain, constipation, diarrhea and hemorrhaging were assessed during RT and up to 6 weeks after RT. Severity of these events were graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. For each patient, an average score for each outcome variable during and after RT calculated as follows: The sum of all severity scores for that variable divided by the number of severity scores for that variable recorded for the patient during the course of RT and for 6 weeks following RT. |
| Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | During radiation therapy and up to 6 weeks post radiation therapy | The number of patients that reported any grade 1 or higher adverse event was divided by the total number of patients evaluated. The analysis was done separately for each of the 5 outcomes and separately during RT and after RT. |
| Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | During radiation therapy and up to 6 weeks post radiation therapy | The maximal severity of each of 5 different adverse even types (Tenesmus, Abdominal Pain, Constipation, Diarrhea, and Rectal Bleeding) were collected as a secondary endpoint. Severity of the events was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. Adverse events were assessed during the course of RT and for 6 weeks following RT. The table below represents the worst grade for each patient for each type. Two-sided chi-square tests will be used to compare each percentage variable between treatment arms for each event type. |
| Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications. | Up to 24 months post radiotherapy | The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint. |
| Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue | Up to 6 weeks post radiotherapy | For each arm, the percentage of patients experience clinically significant deficits in overall QOL and fatigue as indicated by a score of 5 or lower on the 0-10 scale. The analysis was done using the questionnaire that was completed during the first week of radiotherapy (RT) and 6 weeks after RT. |
| Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | Up to 6 weeks post radiation therapy | Questions that were used in this analysis: 2\. Have you had a problem causing you to get up at night to have a bowel movement? 3. Have you had a problem causing you to lose control of your bowel movements? 4. Have you had a problem causing you to have a bowel movement within 30 minutes of a prior bowel movement? 5. Have you had to wear protective clothing or a pad in case you lost control of a bowel movement? 6. Have you had a problem causing you to be unable to tell the difference between stool and gas? 7. Have you had a problem causing you to have stools that are liquid? 1=yes 2=no q08 8. Have you found that once you feel the urge to have a bowel movement, you must do so within 15 minutes to avoid an accident? 9. Have you had cramping with a bowel movement? 10. Have you had blood in your bowel movement? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I: Sulfasalazine Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy. | 42 |
| Arm II: Placebo Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.\>
\> placebo: Given orally | 42 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Arm I: Sulfasalazine | Arm II: Placebo | Total |
|---|---|---|---|
| Age, Continuous | 59 years | 56.5 years | 58 years |
| Region of Enrollment United States | 42 participants | 42 participants | 84 participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Male | 27 Participants | 24 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 42 / 43 | 40 / 42 |
| serious Total, serious adverse events | 1 / 43 | 2 / 42 |
Outcome results
Primary
Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT)
The primary endpoint for this study is the maximal severity of diarrhea toxicity. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening as measured by the CTCAE version 4.0. Assessments were recorded during the course of RT and for 6 weeks following RT. The table below represents the worst graded diarrhea for each patient. A two-sided Wilcoxon rank-sum test will be used to test the equality of the distributions of maximum diarrhea severity grades between the two treatment arms.
Time frame: During radiation therapy and up to 6 weeks post radiation therapy
Population: Two patients in Arm I and one patient from Arm II were not included in the baseline analysis nor the endpoint analyses due to cancellations and protocol violations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I: Sulfasalazine | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Grade 1 | 13 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Grade 3 | 10 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Grade 2 | 8 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Grade 4 | 1 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Grade 0 | 10 Participants |
| Arm II: Placebo | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Grade 4 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Grade 0 | 10 Participants |
| Arm II: Placebo | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Grade 1 | 15 Participants |
| Arm II: Placebo | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Grade 2 | 13 Participants |
| Arm II: Placebo | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | Grade 3 | 4 Participants |
p-value: 0.41Wilcoxon (Mann-Whitney)
Secondary
Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT
For each patient, an Area Under the Curve (AUC) summary statistic will be calculated taking into account the individual severity of diarrhea toxicity over time. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. The curve was constructed using weekly assessments during and after RT. A separate analysis was done during the course of RT and every week for 6 weeks following RT.
Time frame: During radiation therapy and up to 6 weeks post radiation therapy
Population: Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Sulfasalazine | Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT | During RT | 4.0 grade*week | Standard Deviation 3.9 |
| Arm I: Sulfasalazine | Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT | After RT | 1.2 grade*week | Standard Deviation 1.7 |
| Arm II: Placebo | Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT | During RT | 3.3 grade*week | Standard Deviation 3 |
| Arm II: Placebo | Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT | After RT | 1.3 grade*week | Standard Deviation 2.4 |
Comparison: Result comparing Arm I and Arm II during RT.p-value: 0.56Wilcoxon (Mann-Whitney)
Comparison: Result comparing Arm I and Arm II after RT.p-value: 0.74Wilcoxon (Mann-Whitney)
Secondary
Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0
Tenesmus, Abdominal pain, constipation, diarrhea and hemorrhaging were assessed during RT and up to 6 weeks after RT. Severity of these events were graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. For each patient, an average score for each outcome variable during and after RT calculated as follows: The sum of all severity scores for that variable divided by the number of severity scores for that variable recorded for the patient during the course of RT and for 6 weeks following RT.
Time frame: During radiation therapy and up to 6 weeks post radiation therapy
Population: Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Sulfasalazine | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Tenesmus during RT | 0.2 Average Grade of Event | Standard Deviation 0.4 |
| Arm I: Sulfasalazine | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Tenesmus after RT | 0.1 Average Grade of Event | Standard Deviation 0.2 |
| Arm I: Sulfasalazine | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Abdominal pain during RT | 0.3 Average Grade of Event | Standard Deviation 0.4 |
| Arm I: Sulfasalazine | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Abdominal pain after RT | 0.2 Average Grade of Event | Standard Deviation 0.3 |
| Arm I: Sulfasalazine | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Constipation during RT | 0.2 Average Grade of Event | Standard Deviation 0.3 |
| Arm I: Sulfasalazine | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Constipation after RT | 0.1 Average Grade of Event | Standard Deviation 0.3 |
| Arm I: Sulfasalazine | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Diarrhea during RT | 0.8 Average Grade of Event | Standard Deviation 0.7 |
| Arm I: Sulfasalazine | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Diarrhea after RT | 0.3 Average Grade of Event | Standard Deviation 0.4 |
| Arm I: Sulfasalazine | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Rectal bleeding during RT | 0.2 Average Grade of Event | Standard Deviation 0.3 |
| Arm I: Sulfasalazine | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Rectal bleeding after RT | 0.1 Average Grade of Event | Standard Deviation 0.3 |
| Arm II: Placebo | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Diarrhea after RT | 0.3 Average Grade of Event | Standard Deviation 0.4 |
| Arm II: Placebo | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Tenesmus during RT | 0.1 Average Grade of Event | Standard Deviation 0.2 |
| Arm II: Placebo | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Constipation after RT | 0.1 Average Grade of Event | Standard Deviation 0.2 |
| Arm II: Placebo | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Tenesmus after RT | 0.1 Average Grade of Event | Standard Deviation 0.4 |
| Arm II: Placebo | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Rectal bleeding after RT | 0.1 Average Grade of Event | Standard Deviation 0.2 |
| Arm II: Placebo | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Abdominal pain during RT | 0.2 Average Grade of Event | Standard Deviation 0.3 |
| Arm II: Placebo | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Diarrhea during RT | 0.6 Average Grade of Event | Standard Deviation 0.6 |
| Arm II: Placebo | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Abdominal pain after RT | 0.2 Average Grade of Event | Standard Deviation 0.4 |
| Arm II: Placebo | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Rectal bleeding during RT | 0.2 Average Grade of Event | Standard Deviation 0.3 |
| Arm II: Placebo | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Constipation during RT | 0.2 Average Grade of Event | Standard Deviation 0.3 |
Secondary
Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT
The maximal severity of each of 5 different adverse even types (Tenesmus, Abdominal Pain, Constipation, Diarrhea, and Rectal Bleeding) were collected as a secondary endpoint. Severity of the events was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. Adverse events were assessed during the course of RT and for 6 weeks following RT. The table below represents the worst grade for each patient for each type. Two-sided chi-square tests will be used to compare each percentage variable between treatment arms for each event type.
Time frame: During radiation therapy and up to 6 weeks post radiation therapy
Population: Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used for the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain during RT | Grade 2 | 3 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus during RT | Grade 1 | 6 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus during RT | Grade 2 | 7 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus during RT | Grade 3 | 2 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus during RT | Grade 4 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus after RT | Grade 0 | 18 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus after RT | Grade 1 | 5 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus after RT | Grade 2 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus after RT | Grade 3 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus after RT | Grade 4 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain during RT | Grade 0 | 22 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain during RT | Grade 1 | 14 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus during RT | Grade 0 | 27 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain during RT | Grade 3 | 3 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain during RT | Grade 4 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain after RT | Grade 0 | 17 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain after RT | Grade 1 | 8 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain after RT | Grade 2 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain after RT | Grade 3 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain after RT | Grade 4 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation during RT | Grade 0 | 26 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation during RT | Grade 1 | 12 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation during RT | Grade 2 | 4 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation during RT | Grade 3 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation during RT | Grade 4 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation after RT | Grade 0 | 19 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation after RT | Grade 1 | 6 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation after RT | Grade 2 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation after RT | Grade 3 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation after RT | Grade 4 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea during RT | Grade 0 | 10 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea during RT | Grade 1 | 13 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea during RT | Grade 2 | 9 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea during RT | Grade 3 | 9 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea during RT | Grade 4 | 1 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea after RT | Grade 0 | 11 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea after RT | Grade 1 | 12 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea after RT | Grade 2 | 2 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea after RT | Grade 3 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea after RT | Grade 4 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding during RT | Grade 0 | 26 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding during RT | Grade 1 | 16 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding during RT | Grade 2 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding during RT | Grade 3 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding during RT | Grade 4 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding after RT | Grade 0 | 20 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding after RT | Grade 1 | 5 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding after RT | Grade 2 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding after RT | Grade 3 | 0 Participants |
| Arm I: Sulfasalazine | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding after RT | Grade 4 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea after RT | Grade 2 | 3 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus during RT | Grade 0 | 30 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation after RT | Grade 0 | 22 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus during RT | Grade 1 | 9 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding after RT | Grade 3 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus during RT | Grade 2 | 3 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation after RT | Grade 1 | 6 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus during RT | Grade 3 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea after RT | Grade 3 | 2 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus during RT | Grade 4 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation after RT | Grade 2 | 1 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus after RT | Grade 0 | 21 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding during RT | Grade 4 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus after RT | Grade 1 | 7 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation after RT | Grade 3 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus after RT | Grade 2 | 1 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea after RT | Grade 4 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus after RT | Grade 3 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation after RT | Grade 4 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Tenesmus after RT | Grade 4 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding after RT | Grade 2 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain during RT | Grade 0 | 26 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea during RT | Grade 0 | 11 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain during RT | Grade 1 | 12 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding during RT | Grade 0 | 22 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain during RT | Grade 2 | 4 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea during RT | Grade 1 | 14 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain during RT | Grade 3 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding after RT | Grade 0 | 27 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain during RT | Grade 4 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea during RT | Grade 2 | 13 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain after RT | Grade 0 | 24 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding during RT | Grade 1 | 20 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain after RT | Grade 1 | 2 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea during RT | Grade 3 | 4 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain after RT | Grade 2 | 3 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding after RT | Grade 4 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain after RT | Grade 3 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea during RT | Grade 4 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Abdominal pain after RT | Grade 4 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding during RT | Grade 2 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation during RT | Grade 0 | 27 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea after RT | Grade 0 | 14 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation during RT | Grade 1 | 13 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding after RT | Grade 1 | 2 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation during RT | Grade 2 | 2 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Diarrhea after RT | Grade 1 | 10 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation during RT | Grade 3 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Rectal bleeding during RT | Grade 3 | 0 Participants |
| Arm II: Placebo | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | Constipation during RT | Grade 4 | 0 Participants |
Comparison: Comparing Tenesmus During RTp-value: 0.23Chi-squared
Comparison: Comparing Tenesmus after RTp-value: 0.64Chi-squared
Comparison: Comparing abdominal pain during RT.p-value: 0.3Chi-squared
Comparison: Comparing abdominal pain after RTp-value: 0.02Chi-squared
Comparison: Comparing constipation during RTp-value: 0.7Chi-squared
Comparison: Comparing constipation after RTp-value: 0.63Chi-squared
Comparison: Comparing diarrhea during RTp-value: 0.44Chi-squared
Comparison: Comparing diarrhea after RTp-value: 0.48Chi-squared
Comparison: Comparing rectal bleeding during RTp-value: 0.38Chi-squared
p-value: 0.15Chi-squared
Secondary
Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue
For each arm, the percentage of patients experience clinically significant deficits in overall QOL and fatigue as indicated by a score of 5 or lower on the 0-10 scale. The analysis was done using the questionnaire that was completed during the first week of radiotherapy (RT) and 6 weeks after RT.
Time frame: Up to 6 weeks post radiotherapy
Population: All completed QOL questionnaires were included in the analysis. Questionnaires used were completed during the first week during RT and 6 weeks after RT. From Arm I, 41 patients completed questionnaires, 39 during and 26 after RT. For Arm II, 42 patients completed the questions, 40 during and 29 after RT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue | During RT | 17.9 percentage of participants |
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue | After RT | 26.9 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue | During RT | 7.5 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue | After RT | 27.6 percentage of participants |
Secondary
Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT
The number of patients that reported any grade 1 or higher adverse event was divided by the total number of patients evaluated. The analysis was done separately for each of the 5 outcomes and separately during RT and after RT.
Time frame: During radiation therapy and up to 6 weeks post radiation therapy
Population: Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Tenesmus during RT | 35.7 percentage of participants |
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Tenesmus after RT | 11.9 percentage of participants |
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Abdominal pain during RT | 47.6 percentage of participants |
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Abdominal pain after RT | 19.1 percentage of participants |
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Constipation during RT | 38.1 percentage of participants |
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Constipation after RT | 14.3 percentage of participants |
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Diarrhea during RT | 76.2 percentage of participants |
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Diarrhea after RT | 33.3 percentage of participants |
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Rectal bleeding during RT | 38.1 percentage of participants |
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Rectal bleeding after RT | 11.9 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Diarrhea after RT | 35.7 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Tenesmus during RT | 28.6 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Constipation after RT | 16.7 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Tenesmus after RT | 19.1 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Rectal bleeding after RT | 4.8 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Abdominal pain during RT | 38.1 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Diarrhea during RT | 73.8 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Abdominal pain after RT | 11.9 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Rectal bleeding during RT | 47.6 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | Constipation during RT | 35.7 percentage of participants |
Secondary
Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications.
The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint.
Time frame: Up to 24 months post radiotherapy
Population: Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I: Sulfasalazine | Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications. | 48.7 percentage of participants |
| Arm II: Placebo | Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications. | 28.6 percentage of participants |
Secondary
Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire
Questions that were used in this analysis: 2\. Have you had a problem causing you to get up at night to have a bowel movement? 3. Have you had a problem causing you to lose control of your bowel movements? 4. Have you had a problem causing you to have a bowel movement within 30 minutes of a prior bowel movement? 5. Have you had to wear protective clothing or a pad in case you lost control of a bowel movement? 6. Have you had a problem causing you to be unable to tell the difference between stool and gas? 7. Have you had a problem causing you to have stools that are liquid? 1=yes 2=no q08 8. Have you found that once you feel the urge to have a bowel movement, you must do so within 15 minutes to avoid an accident? 9. Have you had cramping with a bowel movement? 10. Have you had blood in your bowel movement?
Time frame: Up to 6 weeks post radiation therapy
Population: All patients that completed the questionnaire were included in the analysis. Questionnaires used were completed during the last week during RT and 6 weeks after RT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q2 | 19 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q3 | 11 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q4 | 33 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q5 | 7 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q6 | 26 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q7 | 11 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q8 | 44 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q9 | 4 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q10 | 7 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q2 | 39 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q3 | 24 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q4 | 55 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q5 | 18 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q6 | 37 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q7 | 37 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q8 | 70 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q9 | 34 percentage of participants |
| Arm I: Sulfasalazine | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q10 | 50 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q6 | 46 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q2 | 10 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q2 | 27 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q3 | 10 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q10 | 29 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q4 | 33 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q3 | 22 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q5 | 0 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q7 | 37 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q6 | 23 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q4 | 56 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q7 | 20 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q9 | 34 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q8 | 43 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q5 | 12 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q9 | 17 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | After RT : Q8 | 61 percentage of participants |
| Arm II: Placebo | Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire | During RT : Q10 | 7 percentage of participants |