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

Mayo Clinic

Status and phase: Completed; Phase 3

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Nasal Vestibulitis

Treatments: Other: Questionnaire Administration; Drug: Placebo Administration; Drug: Rose Geranium in Sesame Oil Nasal Spray

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04620369

MC19C1 (Other Identifier)

NCI-2020-08287 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups, including a placebo group

Arm A (rose geranium in sesame oil nasal spray)

Experimental group

Description:

Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.

Treatment:

Drug: Rose Geranium in Sesame Oil Nasal Spray

Other: Questionnaire Administration

Arm B (isotonic nasal saline)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Administration

Other: Questionnaire Administration