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

Phase 3

Completed

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

• Registration Number: NCT04620369
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-09
• Study Start: 2020-11-13
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (rose geranium in sesame oil nasal spray)	Questionnaire Administration	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.
Arm A (rose geranium in sesame oil nasal spray)	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.
Arm B (isotonic nasal saline)	Placebo Administration	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.
Arm B (isotonic nasal saline)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Response	At 2 weeks after initiating the nasal spray	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.

Secondary Outcome Measures

Name	Time	Method
Nasal symptom analysis	Up to 2 weeks after initiating the nasal spray	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.
Severity of most prominent nasal symptom indicated at baseline	Up to 2 weeks after initiating the nasal spray	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.
Incidence of adverse events (AEs)	Up to 2 weeks after initiating the nasal spray	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.

Trial Locations

Locations (20)

Essentia Health Hibbing Clinic; 🇺🇸 Hibbing, Minnesota, United States

Fairview Range Medical Center; 🇺🇸 Hibbing, Minnesota, United States

Essentia Health Virginia Clinic; 🇺🇸 Virginia, Minnesota, United States

Essentia Health Saint Joseph's Medical Center; 🇺🇸 Brainerd, Minnesota, United States

Mayo Clinic Health System in Albert Lea; 🇺🇸 Albert Lea, Minnesota, United States

Essentia Health - Deer River Clinic; 🇺🇸 Deer River, Minnesota, United States

Essentia Health Cancer Center; 🇺🇸 Duluth, Minnesota, United States

Essentia Health Saint Mary's - Detroit Lakes Clinic; 🇺🇸 Detroit Lakes, Minnesota, United States

Essentia Health Ely Clinic; 🇺🇸 Ely, Minnesota, United States

Fairview Grand Itasca Clinic & Hospital; 🇺🇸 Grand Rapids, Minnesota, United States

Essentia Health - International Falls Clinic; 🇺🇸 International Falls, Minnesota, United States

Monticello Cancer Center; 🇺🇸 Monticello, Minnesota, United States

Essentia Health - Park Rapids; 🇺🇸 Park Rapids, Minnesota, United States

Mayo Clinic Health Systems-Mankato; 🇺🇸 Mankato, Minnesota, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Essentia Health Sandstone; 🇺🇸 Sandstone, Minnesota, United States

Fairview Northland Medical Center; 🇺🇸 Princeton, Minnesota, United States

Sanford Cancer Center Worthington; 🇺🇸 Worthington, Minnesota, United States

Essentia Health - Fosston; 🇺🇸 Fosston, Minnesota, United States

Sanford Thief River Falls Medical Center; 🇺🇸 Thief River Falls, Minnesota, United States