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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
106
Instill isotonic nasal saline intranasally
Ancillary studies
Instill intranasally
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Essentia Health Ely Clinic
Ely, Minnesota, United States
Essentia Health - Fosston
Fosston, Minnesota, United States
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States
Fairview Range Medical Center
Hibbing, Minnesota, United States
...and 10 more locations
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
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
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
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
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