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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04620369
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 100
• Locations: 20
• Arms: 2
• Anticipated Duration (Months): 37.6
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Nasal Vestibulitis	Drug: Placebo Administration; Other: Questionnaire Administration; Drug: Rose Geranium in Sesame Oil Nasal Spray	Phase 3

Detailed Description

PRIMARY OBJECTIVE:

1. 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:

1. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Rose Geranium in Sesame Oil Nasal Spray as an Agent to Improve Symptoms of Nasal Vestibulitis: A Phase III Double Blinded Randomized Controlled Trial
• Actual Study Start Date: Nov 13, 2020
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

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.	Drug: Placebo Administration; Instill isotonic nasal saline intranasally; Other: Questionnaire Administration; Ancillary studies

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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. 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

1. 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.

2. Nasal symptom analysis of dryness, pain, bleeding, and scabbing [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. Shift tables will also be generated to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline after initiating the nasal spray.

3. Nasal symptom analysis of dryness, pain, bleeding, and scabbing [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 1 and 2 weeks post-baseline. 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.

4. Nasal symptom analysis of dryness, pain, bleeding, and scabbing [Up to 2 weeks after initiating the nasal spray]

   Each nasal symptom (dryness, pain, bleeding, and scabbing) will be descriptively summarized, tabulated, and plotted. Patient will be grouped 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.

5. 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.

6. Incidence of adverse events (AEs) [Up to 2 weeks after initiating the nasal spray]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• REGISTRATION-INCLUSION CRITERIA

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Albert Lea	Albert Lea	Minnesota	United States	56007
2	Essentia Health St. Joseph's Medical Center	Brainerd	Minnesota	United States	56401
3	Essentia Health Deer River	Deer River	Minnesota	United States	56636
4	Essentia Health St. Mary's Detroit Lakes	Detroit Lakes	Minnesota	United States	56501
5	Essentia Health Cancer Center	Duluth	Minnesota	United States	55805
6	Essentia Health Ely Clinic	Ely	Minnesota	United States	55731
7	Essentia Health Fosston	Fosston	Minnesota	United States	56542
8	Grand Itasca Clinic & Hospital	Grand Rapids	Minnesota	United States	55744
9	Essentia Health Hibbing	Hibbing	Minnesota	United States	55746
10	Fairview Range Medical Center	Hibbing	Minnesota	United States	55746
11	Essentia Health International Falls Clinic	International Falls	Minnesota	United States	56649
12	Mayo Mankato	Mankato	Minnesota	United States	56001
13	MMCORC Monticello Cancer Center	Monticello	Minnesota	United States	55362
14	Essentia Health Park Rapids	Park Rapids	Minnesota	United States	56470
15	Fairview Northland Medical Center	Princeton	Minnesota	United States	55731
16	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905
17	Essentia Health Sandstone	Sandstone	Minnesota	United States	55072
18	Sanford Thief River Falls Medical Center	Thief River Falls	Minnesota	United States	56701
19	Essentia Health Virginia	Virginia	Minnesota	United States	55792
20	Sanford Worthington	Worthington	Minnesota	United States	56187

Sponsors and Collaborators

• Mayo Clinic
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Charles L Loprinzi, Mayo Clinic in Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04620369
• Other Study ID Numbers: MC19C1; NCI-2020-08287; MC19C1; P30CA015083
• First Posted: Nov 9, 2020
• Last Update Posted: Feb 4, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Feb 4, 2022