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Rose Geranium in Sesame Oil Nasal Spray for the Improvement of Nasal Vestibulitis Symptoms in Cancer Patients Receiving Chemotherapy

Malignant Solid Neoplasm Clinical Trial

Official title:
Rose Geranium in Sesame Oil Nasal Spray as an Agent to Improve Symptoms of Nasal Vestibulitis: A Phase III Double Blinded Randomized Controlled Trial

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04620369
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase Phase 3
Start date November 13, 2020
Completion date December 15, 2022
View Details
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