Female Reproductive Cancer
Conditions
Brief summary
This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with cancer of the female reproductive tract after undergoing surgery. Serum bovine immunoglobulin may help provide nutrition to patients who are not able to eat or digest ordinary food. This may improve the quality of life of patients with gynecological cancer and help them recover more quickly from surgery.
Detailed description
PRIMARY OBJECTIVES: I. To compare the time-to-quality of life (QOL) improvement from baseline in postoperative gynecological cancer patients who are receiving oral serum bovine immunoglobulin (SBI) vs. placebo. SECONDARY OBJECTIVES: I. To compare the surgical complication rates between oral SBI vs. placebo up to 1 month post-surgery (safety endpoint). II. To compare the QOL, as derived from the previously-validated Symptom Distress Scale, the Postoperative Quality of Life questionnaire (PQL), and the uniscale (overall QOL item) between patients receiving oral SBI vs. placebo. III. To compare the grade 2 or worse adverse event rates for patients receiving oral SBI vs. placebo. IV. To characterize the adverse event profile of oral SBI in postoperative gynecological cancer patients (safety endpoint). V. To compare supplement adherence between patients receiving oral SBI vs. placebo. TERTIARY OBJECTIVES: I. To explore whether candidate biomarkers are modified with SBI versus placebo. II. As part of ongoing research, to bank leftover blood samples for future studies. III. To explore quality of life during postoperative recovery after gynecologic surgery, regardless of whether or not patients take the study intervention/placebo or discontinue intervention/placebo early. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive SBI orally (PO) twice daily (BID) on days 1-28. ARM II: Patients receive placebo PO BID on days 1-28. In both arms, treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks.
Interventions
BIOLOGICALserum-derived bovine immunoglobulin protein isolate
Given PO
OTHERplacebo
Given PO
OTHERlaboratory biomarker analysis
Correlative studies
OTHERquality-of-life assessment
Ancillary studies
OTHERquestionnaire administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of gynecological cancer of any type or strong suspicion for cancer * Patients must have begun postoperative oral intake of food prior to registration * Open laparotomy or laparoscopic surgery undertaken with cancer therapeutic intent (not a subsequent surgery to manage a postoperative complication) that had occurred =\< 7 days prior to registration and that entailed more than a simple hysterectomy * Creatinine =\< 1.5 x the upper limit of normal (ULN) * Absolute neutrophil count \>= 1500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Ability to complete questionnaire(s) by themselves or with assistance * Provide informed written consent * Negative (serum) pregnancy test done =\< 7 days prior to randomization, for women of childbearing potential only * Willing to provide mandatory baseline blood samples for correlative research purposes
Exclusion criteria
* Symptomatic and/or untreated brain metastases * Ongoing parenteral nutrition (receiving intravenous nutrition support at the time of enrollment); note: patients may be receiving maintenance intravenous (IV) fluids * Current enrollment in any other trial that entails the concurrent administration of any other agent designed to enhance postoperative recovery * Allergy to beef
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-QOL Improvement Defined as Any Increase in the QOL Score Measured Using the Total Score of the 14-item Postoperative Quality of Life (PQL) Tool | up to 25 months | For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). The primary analysis will be a comparison of oral SBI vs. placebo using a two-sided log-rank test between the 2 Kaplan-Meier curves.the total score of the 14-item Postoperative Quality of Life (PQL) tool \[15\] will be used, where the total score could range from 0 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0 | up to 25 months | Frequency tables will be reviewed to determine adverse event patterns, this data is reported in the adverse events section of this report. Below is the number of patients that experienced an adverse event greater than or equal to 2. |
| Surgical Complication Rates | Up to 1 month post-surgery | Compared between the 2 arms using Chi-Square or Fisher's Exact tests. |
| Intervention Compliance Assessed Using the Compliance Questionnaire | up to 25 months | The frequency and percentage for each Compliance Questionnaire category will be summarized descriptively by cycle and by intervention arm. In addition, cycle by cycle compliance data will be compared between the 2 arms using a Chi-square test. |
| Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale | up to 25 months | All 14 of the individual items from the PQL tool, along with the 4 additional items after the PQL questions will be analyzed and compared between the 2 intervention arms. Differences between post-randomization and baseline QOL scores will be analyzed and compared between the 2 arms using a Wilcoxon Rank-sum test. Also, other graphical and statistical methods will be used to compare the QOL between the 2 arms over time. For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale. |
| Change in QOL in Patients Who do Not Start Intervention or Discontinue Early, Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale | Baseline up to 25 months | Analysis will be descriptive in nature to see if these patients have a poorer QOL than patients who stay on study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm II (Placebo) Patients receive placebo PO BID on days 1-28.\>\>
\>\> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.\>\>
\>\> placebo: Given PO\>\>
\>\> laboratory biomarker analysis: Correlative studies\>\>
\>\> quality-of-life assessment: Ancillary studies\>\>
\>\> questionnaire administration: Ancillary studies | 32 |
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) Patients receive SBI PO BID on days 1-28.\>\>
\>\> Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.\>\>
\>\> serum-derived bovine immunoglobulin protein isolate: Given PO\>\>
\>\> laboratory biomarker analysis: Correlative studies\>\>
\>\> quality-of-life assessment: Ancillary studies\>\>
\>\> questionnaire administration: Ancillary studies | 26 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 10 | 14 |
Baseline characteristics
| Characteristic | Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Total | Arm II (Placebo) |
|---|---|---|---|
| Age, Continuous | 62 Years | 62 Years | 62 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 24 Participants | 53 Participants | 29 Participants |
| Sex: Female, Male Female | 26 Participants | 58 Participants | 32 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 18 |
| other Total, other adverse events | 15 / 16 | 15 / 18 |
| serious Total, serious adverse events | 3 / 16 | 3 / 18 |
Outcome results
Primary
Time-to-QOL Improvement Defined as Any Increase in the QOL Score Measured Using the Total Score of the 14-item Postoperative Quality of Life (PQL) Tool
For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). The primary analysis will be a comparison of oral SBI vs. placebo using a two-sided log-rank test between the 2 Kaplan-Meier curves.the total score of the 14-item Postoperative Quality of Life (PQL) tool \[15\] will be used, where the total score could range from 0 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale.
Time frame: up to 25 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Time-to-QOL Improvement Defined as Any Increase in the QOL Score Measured Using the Total Score of the 14-item Postoperative Quality of Life (PQL) Tool | 4.86 Months |
| Arm II (Placebo) | Time-to-QOL Improvement Defined as Any Increase in the QOL Score Measured Using the Total Score of the 14-item Postoperative Quality of Life (PQL) Tool | 3.29 Months |
Secondary
Change in QOL in Patients Who do Not Start Intervention or Discontinue Early, Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale
Analysis will be descriptive in nature to see if these patients have a poorer QOL than patients who stay on study.
Time frame: Baseline up to 25 months
Population: All evaluable patients who never started intervention or discontinue early. All patients completed the study, no patients are evaluable for this outcome.
Secondary
Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale
All 14 of the individual items from the PQL tool, along with the 4 additional items after the PQL questions will be analyzed and compared between the 2 intervention arms. Differences between post-randomization and baseline QOL scores will be analyzed and compared between the 2 arms using a Wilcoxon Rank-sum test. Also, other graphical and statistical methods will be used to compare the QOL between the 2 arms over time. For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale.
Time frame: up to 25 months
Population: All evaluable patients
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale | Improvement | 11 Participants |
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale | No Improvement | 5 Participants |
| Arm II (Placebo) | Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale | Improvement | 13 Participants |
| Arm II (Placebo) | Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale | No Improvement | 4 Participants |
p-value: 0.62Chi-squared
Secondary
Intervention Compliance Assessed Using the Compliance Questionnaire
The frequency and percentage for each Compliance Questionnaire category will be summarized descriptively by cycle and by intervention arm. In addition, cycle by cycle compliance data will be compared between the 2 arms using a Chi-square test.
Time frame: up to 25 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 1 | Always to Usually Compliant | 8 Participants |
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 1 | Occasionally to Never Compliant | 5 Participants |
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 1 | Missing | 3 Participants |
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 1 | Patient off treatment (NA) | 0 Participants |
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 2 | Always to Usually Compliant | 3 Participants |
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 2 | Occasionally to Never Compliant | 1 Participants |
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 2 | Missing | 0 Participants |
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 2 | Patient off treatment (NA) | 12 Participants |
| Arm II (Placebo) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 2 | Patient off treatment (NA) | 9 Participants |
| Arm II (Placebo) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 1 | Always to Usually Compliant | 13 Participants |
| Arm II (Placebo) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 2 | Always to Usually Compliant | 7 Participants |
| Arm II (Placebo) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 1 | Occasionally to Never Compliant | 4 Participants |
| Arm II (Placebo) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 2 | Missing | 1 Participants |
| Arm II (Placebo) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 1 | Missing | 0 Participants |
| Arm II (Placebo) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 2 | Occasionally to Never Compliant | 0 Participants |
| Arm II (Placebo) | Intervention Compliance Assessed Using the Compliance Questionnaire | Cycle 1 | Patient off treatment (NA) | 0 Participants |
Secondary
Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0
Frequency tables will be reviewed to determine adverse event patterns, this data is reported in the adverse events section of this report. Below is the number of patients that experienced an adverse event greater than or equal to 2.
Time frame: up to 25 months
Population: All evaluable patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0 | 5 Participants |
| Arm II (Placebo) | Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0 | 10 Participants |
Secondary
Surgical Complication Rates
Compared between the 2 arms using Chi-Square or Fisher's Exact tests.
Time frame: Up to 1 month post-surgery
Population: All evaluable patients
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Surgical Complication Rates | Severe Complication | 3 Participants |
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Surgical Complication Rates | Moderate Complication | 2 Participants |
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Surgical Complication Rates | Mild Complication | 10 Participants |
| Arm I (Serum-derived Bovine Immunoglobulin Protein Isolate) | Surgical Complication Rates | No Complication | 1 Participants |
| Arm II (Placebo) | Surgical Complication Rates | No Complication | 1 Participants |
| Arm II (Placebo) | Surgical Complication Rates | Severe Complication | 3 Participants |
| Arm II (Placebo) | Surgical Complication Rates | Mild Complication | 6 Participants |
| Arm II (Placebo) | Surgical Complication Rates | Moderate Complication | 7 Participants |
p-value: 0.29Fisher Exact