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

NCT ID: NCT04620369

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-13
• Study Completion Date: 2022-12-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Arm A (rose geranium in sesame oil nasal spray)

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.

Group Type: EXPERIMENTAL

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Rose Geranium in Sesame Oil Nasal Spray

Intervention Type: DRUG

Instill intranasally

Arm B (isotonic nasal saline)

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.

Group Type: PLACEBO_COMPARATOR

Placebo Administration

Intervention Type: DRUG

Instill isotonic nasal saline intranasally

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Placebo Administration

Instill isotonic nasal saline intranasally

Intervention Type: DRUG

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Rose Geranium in Sesame Oil Nasal Spray

Instill intranasally

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles L Loprinzi

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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

Countries

United States

References

Cathcart-Rake EJ, Steinert K, Smith D, Lewis-Peters S, Giridhar K, Novotny P, Dauer D, O'Connor A, Thome S, Erickson MK, Friday BB, Loprinzi CL. Rose geranium in sesame oil nasal spray to improve nasal vestibulitis symptoms: a randomized controlled trial. Support Care Cancer. 2024 May 24;32(6):379. doi: 10.1007/s00520-024-08580-6.

Reference Type: DERIVED

PMID: 38789656 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2020-08287

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC19C1

Identifier Type: -

Identifier Source: org_study_id