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

NCT04620369 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: MC19C1NCI-2020-08287
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 20

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Response

  Response is determined from a patient global impression of change scale and is defined as a patient reporting that the nasal symptom that was most prominent prior to starting the study has been moderately better or very much better 2 weeks after initiating the nasal spray. The number and percentage of patients experiencing a response 2 weeks after initiating\>\>\> the nasal spray will be estimated within each randomized arm and the corresponding two-sided 95% exact (Clopper-Pearson) confidence interval provided. A between-arm comparison of the proportion of patients experiencing a response 2 weeks after initiating the nasal spray will be made using the Fisher's exact test.

  At 2 weeks after initiating the nasal spray

Secondary Outcomes (3)

• Severity of Most Prominent Nasal Symptom Indicated at Baseline

  Up to 2 weeks after initiating the nasal spray

• Nasal Symptom Analysis

  Up to 2 weeks after initiating the nasal spray

• Number of Participants With Adverse Events (AEs)

  Up to 2 weeks after initiating the nasal spray

Study Arms (2)

Arm A (rose geranium in sesame oil nasal spray)

EXPERIMENTAL

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.

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

Arm B (isotonic nasal saline)

PLACEBO COMPARATOR

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.

Drug: Placebo Administration; Other: Questionnaire Administration

Interventions

Placebo Administration DRUG

Instill isotonic nasal saline intranasally

Arm B (isotonic nasal saline)

Questionnaire Administration OTHER

Ancillary studies

Arm A (rose geranium in sesame oil nasal spray); Arm B (isotonic nasal saline)

Rose Geranium in Sesame Oil Nasal Spray DRUG

Instill intranasally

Arm A (rose geranium in sesame oil nasal spray)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (20)

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007, United States

Location

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

Location

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636, United States

Location

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, 56501, United States

Location

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

Location

Essentia Health Ely Clinic

Ely, Minnesota, 55731, United States

Location

Essentia Health - Fosston

Fosston, Minnesota, 56542, United States

Location

Fairview Grand Itasca Clinic & Hospital

Grand Rapids, Minnesota, 55744, United States

Location

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746, United States

Location

Fairview Range Medical Center

Hibbing, Minnesota, 55746, United States

Location

Essentia Health - International Falls Clinic

International Falls, Minnesota, 56649, United States

Location

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, 56001, United States

Location

Monticello Cancer Center

Monticello, Minnesota, 55362, United States

Location

Essentia Health - Park Rapids

Park Rapids, Minnesota, 56470, United States

Location

Fairview Northland Medical Center

Princeton, Minnesota, 55371, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Essentia Health Sandstone

Sandstone, Minnesota, 55072, United States

Location

Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota, 56701, United States

Location

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States

Location

Sanford Cancer Center Worthington

Worthington, Minnesota, 56187, United States

Location

Related Publications (1)

• 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.

  PMID: 38789656 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Charles L. Loprinzi
• Organization: Mayo Clinic

cloprinzi@mayo.edu

507-284-2511

Study Officials

• Charles L Loprinzi

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 9, 2020
• Study Start: November 13, 2020
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: December 3, 2025
• Results First Posted: December 3, 2025

Record last verified: 2023-10

Locations

US (20)