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

Overview

About this study

This trial will be an evaluation of rose geranium in sesame oil nasal spray versus nasal saline. Rose geranium in sesame oil nasal spray is a compounded preparation, containing 0.2 mL (4 drops) of pharmaceutical grade rose geranium oil to 119.8 mL of pharmaceutical grade sesame oil and then put into 30mL bottles. This is the same compound that was used in the aforementioned study of patients with hereditary hemorrhagic telangiectasia (2). Isotonic nasal saline will contain 0.9% sodium chloride with benzalkonium chloride, as a preservative, in a 30 mL bottle.

Treatment duration

The therapy will be given for two weeks. This should give us adequate time to determine whether rose geranium in sesame oil nasal spray can decrease nasal vestibulitis. Following that two week period, participants taking the saline spray will be allowed to cross over to the other spray. Subjects may cross over within two weeks after completion of treatment and be on therapy for an additional two weeks such a patient must still be receiving chemotherapy or within 2 weeks of the last chemotherapy dose, at the time of crossover.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Registration - Inclusion Criteria

Age ≥ 18 years.
Diagnosed with cancer and receiving chemotherapy.
Able to provide informed consent.
Willingness to complete questionnaires.
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.

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.

Re-Registration:

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Charles Loprinzi, M.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Albert Lea, Minn. Mayo Clinic principal investigator Mina Hanna, M.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Mankato, Minn. Mayo Clinic principal investigator Stephan Thome, M.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charles Loprinzi, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Albert Lea, Minn.

Mayo Clinic principal investigator

Mina Hanna, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Stephan Thome, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials