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

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ClinicalTrials.gov Identifier: NCT04620369
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : January 14, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

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:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 13, 2020
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Sesame oil

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




Primary Outcome Measures :
  1. Response [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620369


Locations
Show Show 18 study locations
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Charles L Loprinzi Mayo Clinic in Rochester
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04620369    
Other Study ID Numbers: MC19C1
NCI-2020-08287 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC19C1 ( Other Identifier: Mayo Clinic in Rochester )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: January 2022

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