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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• REGISTRATION-INCLUSION CRITERIA

• 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-EXCLUSION CRITERIA

• Predisposition to epistaxis prior to the initiation of cancer-directed therapy (more than once a month over the previous year)

• Planned initiation or continuation of any topical nasal treatment other than the studied nasal spray,(such as nasal steroids, Ayr nasal gel, Neosporin ointment or nasal administration of petroleum jelly). Taking Imitrex for migraines is acceptable

• Previous exposure to rose geranium in sesame oil nasal spray

• Concurrent upper respiratory tract infection

• History of allergic or other adverse reactions to sesame oil or essential rose geranium oil

• Any other reason that the study clinician or investigator feels precludes safe or appropriate inclusion in this study

• Vulnerable populations: pregnant women, prisoners, mentally handicapped

• RE-REGISTRATION

• The patient will be un-blinded and determined to have been on the saline arm, when initially randomized