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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Nasal Vestibulitis

In brief

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.

Key facts

Study ID

NCT04620369

Run by

Mayo Clinic

People needed

106

Starts

2020-11-13

Expected to finish

2022-12-15

Last updated by the study team

2025-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Essentia Health - International Falls Clinic — International Falls, Minnesota, United States
• Mayo Clinic Health Systems-Mankato — Mankato, Minnesota, United States
• Monticello Cancer Center — Monticello, Minnesota, United States
• Essentia Health - Park Rapids — Park Rapids, Minnesota, United States
• Fairview Northland Medical Center — Princeton, Minnesota, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Essentia Health Sandstone — Sandstone, Minnesota, United States
• Sanford Thief River Falls Medical Center — Thief River Falls, Minnesota, United States
• Essentia Health Virginia Clinic — Virginia, Minnesota, United States
• Sanford Cancer Center Worthington — Worthington, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.