Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Nasal Vestibulitis
Conditions
Brief summary
This phase III trial compares rose geranium in sesame oil nasal spray to isotonic nasal saline in improving symptoms of nasal vestibulitis in cancer patients receiving chemotherapy. Nasal (nose) symptoms (dryness, discomfort, bleeding, scabbing or sores) due to inflammation, termed nasal vestibulitis, is reported as a side effect of cancer-directed therapy. Rose geranium in sesame oil nasal spray may work better than isotonic nasal saline in improving symptoms of nasal vestibulitis.
Detailed description
PRIMARY OBJECTIVE: I. To determine the ability of rose geranium in sesame oil nasal spray to alleviate nasal vestibulitis in patients undergoing systemic, antineoplastic therapy when compared with isotonic nasal saline. SECONDARY OBJECTIVE: I. To assess toxicities related to rose geranium in sesame oil nasal spray in this study situation. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril twice daily (BID) on days 1-14 in the absence of unacceptable toxicity. ARM B: Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.
Interventions
DRUGRose Geranium in Sesame Oil Nasal Spray
Instill intranasally
DRUGPlacebo Administration
Instill isotonic nasal saline intranasally
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
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
* REGISTRATION-INCLUSION CRITERIA * Age \>= 18 years and be diagnosed with cancer and receiving chemotherapy * Ability to provide informed consent * Willingness to complete questionnaires * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 * One or more of the following nasal symptoms for which the patient reports they would appreciate treatment. Symptoms must have started after the initiation of systemic, antineoplastic therapies, be attributed to the systemic, antineoplastic therapies, and symptoms must be reported as being moderate (corresponding to a score of 2) or worse on a scale from mild (1) to very severe (4) on at least one of the items below. * Dryness * Discomfort/pain * Bleeding * Scabbing * Sores
Exclusion criteria
* REGISTRATION-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response | At 2 weeks after initiating the nasal spray | Response is determined from a patient global impression of change scale and is defined as a patient reporting that the nasal symptom that was most prominent prior to starting the study has been moderately better or very much better 2 weeks after initiating the nasal spray. The number and percentage of patients experiencing a response 2 weeks after initiating\>\>\> the nasal spray will be estimated within each randomized arm and the corresponding two-sided 95% exact (Clopper-Pearson) confidence interval provided. A between-arm comparison of the proportion of patients experiencing a response 2 weeks after initiating the nasal spray will be made using the Fisher's exact test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Most Prominent Nasal Symptom Indicated at Baseline | Up to 2 weeks after initiating the nasal spray | For the most prominent nasal symptom indicated at baseline, patients will record the severity on an ordinal scale of 1=mild, 2=moderate, 3=severe, and 4=very severe. Two weeks after initiating the nasal spray the patients will record the severity of the most prominent nasal symptom as 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. A shift table will be created to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift two-weeks after initiating the nasal spray. In addition, the within-patient change in severity of the most prominent nasal symptom will be calculated 2 weeks after initiating the nasal spray and summarized descriptively within each arm. The Wilcoxon rank-sum test will be performed, and the methods of Hodges and Lehmann will be applied to compute a point estimate and confidence interval for the difference in medians between the two arms. |
| Nasal Symptom Analysis | Up to 2 weeks after initiating the nasal spray | Each nasal symptom (dryness, pain, bleeding, and scabbing) will be descriptively summarized, tabulated, and plotted according to arm at baseline, and at 1 and 2 weeks post-baseline; additionally, will group patients according to baseline severity for each symptom and summarize changes over time and according to arm. Shift tables will also be generated to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift one- and two-weeks after initiating the nasal spray. The Nasal symptom scale is 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe with very severe being the worst outcome. |
| Number of Participants With Adverse Events (AEs) | Up to 2 weeks after initiating the nasal spray | The constellation of AEs as scored using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 will be summarized within arms by reporting the number and percentage of patients. Specifically, to evaluate the AE profiles associated with each arm, the maximum grade for each type of AE will be recorded for each patient and frequency tables will be reviewed to determine overall patterns and compared between arms using Wilcoxon tests. |
Countries
United States
Participant flow
Recruitment details
2 patients on Arm A did crossover despite the protocol saying otherwise
Participants by arm
| Arm | Count |
|---|---|
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\> \>\>\>
\>
\>\>\> Questionnaire Administration: Ancillary studies\>
\>\>\>
\>
\>\>\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally | 43 |
| Arm B (Isotonic Nasal Saline) Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\> \>\>\>
\>
\>\>\> Questionnaire Administration: Ancillary studies\>
\>\>\>
\>
\>\>\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally | 41 |
| Total | 84 |
Baseline characteristics
| Characteristic | Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Arm B (Isotonic Nasal Saline) | Total |
|---|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 12.3 | 59.3 years STANDARD_DEVIATION 12.3 | 59.3 years STANDARD_DEVIATION 12.3 |
| Currently smoking No | 36 Participants | 37 Participants | 73 Participants |
| Currently smoking Yes | 7 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 40 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Most bothersome nasal symptom Bleeding | 19 Participants | 10 Participants | 29 Participants |
| Most bothersome nasal symptom Discomfort | 7 Participants | 4 Participants | 11 Participants |
| Most bothersome nasal symptom Dryness | 15 Participants | 15 Participants | 30 Participants |
| Most bothersome nasal symptom Scabbing | 0 Participants | 7 Participants | 7 Participants |
| Most bothersome nasal symptom Sores | 2 Participants | 5 Participants | 7 Participants |
| Prior history of allergies or asthma | 16 Participants | 15 Participants | 31 Participants |
| Prior treatments for nose symptoms 0 | 32 Participants | 25 Participants | 57 Participants |
| Prior treatments for nose symptoms 1 | 7 Participants | 11 Participants | 18 Participants |
| Prior treatments for nose symptoms 2 | 2 Participants | 5 Participants | 7 Participants |
| Prior treatments for nose symptoms 3+ | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Female | 36 Participants | 37 Participants | 73 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
| Taking aspirin or blood thinners | 8 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 53 | 0 / 2 | 0 / 37 |
| other Total, other adverse events | 10 / 53 | 9 / 53 | 0 / 2 | 4 / 37 |
| serious Total, serious adverse events | 0 / 53 | 0 / 53 | 0 / 2 | 0 / 37 |
Outcome results
Primary
Response
Response is determined from a patient global impression of change scale and is defined as a patient reporting that the nasal symptom that was most prominent prior to starting the study has been moderately better or very much better 2 weeks after initiating the nasal spray. The number and percentage of patients experiencing a response 2 weeks after initiating\>\>\> the nasal spray will be estimated within each randomized arm and the corresponding two-sided 95% exact (Clopper-Pearson) confidence interval provided. A between-arm comparison of the proportion of patients experiencing a response 2 weeks after initiating the nasal spray will be made using the Fisher's exact test.
Time frame: At 2 weeks after initiating the nasal spray
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Response | some nasal symptom improvement | 40 Participants |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Response | worsening of nasal symptoms | 2 Participants |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Response | no change | 1 Participants |
| Arm B (Isotonic Nasal Saline) | Response | worsening of nasal symptoms | 4 Participants |
| Arm B (Isotonic Nasal Saline) | Response | no change | 12 Participants |
| Arm B (Isotonic Nasal Saline) | Response | some nasal symptom improvement | 25 Participants |
Secondary
Nasal Symptom Analysis
Each nasal symptom (dryness, pain, bleeding, and scabbing) will be descriptively summarized, tabulated, and plotted according to arm at baseline, and at 1 and 2 weeks post-baseline; additionally, will group patients according to baseline severity for each symptom and summarize changes over time and according to arm. Shift tables will also be generated to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift one- and two-weeks after initiating the nasal spray. The Nasal symptom scale is 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe with very severe being the worst outcome.
Time frame: Up to 2 weeks after initiating the nasal spray
Population: Some patients missed their post-baseline assessment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Tenderness/Discomfort Week 0 | 2.63 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Bleeding Week 2 | 1.72 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Dryness Week 1 | 2.02 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Scabbing Week 0 | 2.72 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Tenderness/Discomfort Week 1 | 1.65 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Scabbing Week 1 | 1.74 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Dryness Week 0 | 2.95 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Scabbing Week 2 | 1.63 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Tenderness/Discomfort Week 2 | 1.67 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Sores Week 0 | 2.14 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Dryness Week 2 | 2 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Sores Week 1 | 1.58 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Bleeding Week 0 | 2.56 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Sores Week 2 | 1.47 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Most Prominent Symptom Week 2 | 1.93 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Most Prominent Symptom Week 0 | 3.09 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Bleeding Week 1 | 2 score on a scale |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Nasal Symptom Analysis | Most Prominent Symptom Week 1 | 2.09 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Bleeding Week 1 | 2.48 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Most Prominent Symptom Week 2 | 2.39 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Dryness Week 0 | 3.14 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Dryness Week 1 | 2.8 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Dryness Week 2 | 2.46 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Tenderness/Discomfort Week 0 | 2.46 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Tenderness/Discomfort Week 1 | 2.25 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Tenderness/Discomfort Week 2 | 1.98 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Bleeding Week 0 | 2.68 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Most Prominent Symptom Week 1 | 2.73 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Bleeding Week 2 | 2 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Scabbing Week 0 | 2.49 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Scabbing Week 1 | 2.25 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Scabbing Week 2 | 2.17 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Sores Week 0 | 1.93 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Sores Week 1 | 1.8 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Sores Week 2 | 1.78 score on a scale |
| Arm B (Isotonic Nasal Saline) | Nasal Symptom Analysis | Most Prominent Symptom Week 0 | 3.17 score on a scale |
Secondary
Number of Participants With Adverse Events (AEs)
The constellation of AEs as scored using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 will be summarized within arms by reporting the number and percentage of patients. Specifically, to evaluate the AE profiles associated with each arm, the maximum grade for each type of AE will be recorded for each patient and frequency tables will be reviewed to determine overall patterns and compared between arms using Wilcoxon tests.
Time frame: Up to 2 weeks after initiating the nasal spray
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Number of Participants With Adverse Events (AEs) | Grade 3 | 0 Participants |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Number of Participants With Adverse Events (AEs) | Grade 4 | 0 Participants |
| Arm B (Isotonic Nasal Saline) | Number of Participants With Adverse Events (AEs) | Grade 3 | 0 Participants |
| Arm B (Isotonic Nasal Saline) | Number of Participants With Adverse Events (AEs) | Grade 4 | 0 Participants |
Secondary
Severity of Most Prominent Nasal Symptom Indicated at Baseline
For the most prominent nasal symptom indicated at baseline, patients will record the severity on an ordinal scale of 1=mild, 2=moderate, 3=severe, and 4=very severe. Two weeks after initiating the nasal spray the patients will record the severity of the most prominent nasal symptom as 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. A shift table will be created to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift two-weeks after initiating the nasal spray. In addition, the within-patient change in severity of the most prominent nasal symptom will be calculated 2 weeks after initiating the nasal spray and summarized descriptively within each arm. The Wilcoxon rank-sum test will be performed, and the methods of Hodges and Lehmann will be applied to compute a point estimate and confidence interval for the difference in medians between the two arms.
Time frame: Up to 2 weeks after initiating the nasal spray
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Severity of Most Prominent Nasal Symptom Indicated at Baseline | Week 0 | 100 percentage of Week 0 score | Standard Deviation 0 |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Severity of Most Prominent Nasal Symptom Indicated at Baseline | Week 1 | 70.155 percentage of Week 0 score | Standard Deviation 4.52 |
| Arm A (Rose Geranium in Sesame Oil Nasal Spray) | Severity of Most Prominent Nasal Symptom Indicated at Baseline | Week 2 | 65.0 percentage of Week 0 score | Standard Deviation 5.154 |
| Arm B (Isotonic Nasal Saline) | Severity of Most Prominent Nasal Symptom Indicated at Baseline | Week 0 | 100 percentage of Week 0 score | Standard Deviation 0 |
| Arm B (Isotonic Nasal Saline) | Severity of Most Prominent Nasal Symptom Indicated at Baseline | Week 1 | 91.458 percentage of Week 0 score | Standard Deviation 5.598 |
| Arm B (Isotonic Nasal Saline) | Severity of Most Prominent Nasal Symptom Indicated at Baseline | Week 2 | 77.724 percentage of Week 0 score | Standard Deviation 4.89 |