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

Rose Geranium in Sesame Oil Nasal Spray as an Agent to Improve Symptoms of Nasal Vestibulitis: A Phase III Double Blinded Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Nasal Vestibulitis
• Intervention / Treatment: Other: Questionnaire Administration; Drug: Rose Geranium in Sesame Oil Nasal Spray; Drug: Placebo Administration

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Albert Lea, Minnesota, United States, 56007
      • Mayo Clinic Health System in Albert Lea
    • Brainerd, Minnesota, United States, 56401
      • Essentia Health Saint Joseph's Medical Center
    • Deer River, Minnesota, United States, 56636
      • Essentia Health - Deer River Clinic
    • Detroit Lakes, Minnesota, United States, 56501
      • Essentia Health Saint Mary's - Detroit Lakes Clinic
    • Duluth, Minnesota, United States, 55805
      • Essentia Health Cancer Center
    • Ely, Minnesota, United States, 55731
      • Essentia Health Ely Clinic
    • Fosston, Minnesota, United States, 56542
      • Essentia Health - Fosston
    • Grand Rapids, Minnesota, United States, 55744
      • Fairview Grand Itasca Clinic & Hospital
    • Hibbing, Minnesota, United States, 55746
      • Essentia Health Hibbing Clinic
    • Hibbing, Minnesota, United States, 55746
      • Fairview Range Medical Center
    • International Falls, Minnesota, United States, 56649
      • Essentia Health - International Falls Clinic
    • Mankato, Minnesota, United States, 56001
      • Mayo Clinic Health Systems-Mankato
    • Monticello, Minnesota, United States, 55362
      • Monticello Cancer Center
    • Park Rapids, Minnesota, United States, 56470
      • Essentia Health - Park Rapids
    • Princeton, Minnesota, United States, 55371
      • Fairview Northland Medical Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
    • Sandstone, Minnesota, United States, 55072
      • Essentia Health Sandstone
    • Thief River Falls, Minnesota, United States, 56701
      • Sanford Thief River Falls Medical Center
    • Virginia, Minnesota, United States, 55792
      • Essentia Health Virginia Clinic
    • Worthington, Minnesota, United States, 56187
      • Sanford Cancer Center Worthington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Drug: Rose Geranium in Sesame Oil Nasal Spray; Instill intranasally
Placebo Comparator: 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.	Other: Questionnaire Administration; Ancillary studies; Drug: Placebo Administration; Instill isotonic nasal saline intranasally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Most Prominent Nasal Symptom Indicated at Baseline	For the most prominent nasal symptom indicated at baseline, patients will record the severity on an ordinal scale of 1=mild, 2=moderate, 3=severe, and 4=very severe. Two weeks after initiating the nasal spray the patients will record the severity of the most prominent nasal symptom as 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. A shift table will be created to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift two-weeks after initiating the nasal spray. In addition, the within-patient change in severity of the most prominent nasal symptom will be calculated 2 weeks after initiating the nasal spray and summarized descriptively within each arm. The Wilcoxon rank-sum test will be performed, and the methods of Hodges and Lehmann will be applied to compute a point estimate and confidence interval for the difference in medians between the two arms.	Up to 2 weeks after initiating the nasal spray
Nasal Symptom Analysis	Each nasal symptom (dryness, pain, bleeding, and scabbing) will be descriptively summarized, tabulated, and plotted according to arm at baseline, and at 1 and 2 weeks post-baseline; additionally, will group patients according to baseline severity for each symptom and summarize changes over time and according to arm. Shift tables will also be generated to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift one- and two-weeks after initiating the nasal spray. The Nasal symptom scale is 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe with very severe being the worst outcome.	Up to 2 weeks after initiating the nasal spray
Number of Participants With Adverse Events (AEs)	The constellation of AEs as scored using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 will be summarized within arms by reporting the number and percentage of patients. Specifically, to evaluate the AE profiles associated with each arm, the maximum grade for each type of AE will be recorded for each patient and frequency tables will be reviewed to determine overall patterns and compared between arms using Wilcoxon tests.	Up to 2 weeks after initiating the nasal spray

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Charles L Loprinzi, Mayo Clinic in Rochester

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: MC19C1 (Mayo Clinic in Rochester); NCI-2020-08287 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No