NCT04620369

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Nasal Vestibulitis

Interventions

Type	Name	Description
DRUG	Placebo Administration	Instill isotonic nasal saline intranasally
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Rose Geranium in Sesame Oil Nasal Spray	Instill intranasally

Timeline

• Start date: 2020-11-13
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2020-11-09
• Last updated: 2025-12-03
• Results posted: 2025-12-03

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study