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Hematopoietic and Lymphoid Cell NeoplasmPhase 3NCT04620369

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

A Phase 3 study testing Questionnaire Administration and Rose Geranium in Sesame Oil Nasal Spray in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Questionnaire Administration and Rose Geranium in Sesame Oil Nasal Spray
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
20 sitesUnited States
Study dates
13 Nov 2020to 15 Dec 2022
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • Dryness
  • Discomfort/pain
  • Bleeding
  • Scabbing
  • Sores

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Ely Clinic

    Ely, Minnesota, 55731

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

  • Fairview Grand Itasca Clinic & Hospital

    Grand Rapids, Minnesota, 55744

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

  • Fairview Range Medical Center

    Hibbing, Minnesota, 55746

  • Essentia Health - International Falls Clinic

    International Falls, Minnesota, 56649

  • Mayo Clinic Health Systems-Mankato

    Mankato, Minnesota, 56001

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Essentia Health - Park Rapids

    Park Rapids, Minnesota, 56470

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072

  • Sanford Thief River Falls Medical Center

    Thief River Falls, Minnesota, 56701

  • Essentia Health Virginia Clinic

    Virginia, Minnesota, 55792

  • Sanford Cancer Center Worthington

    Worthington, Minnesota, 56187

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Placebo Administration, Questionnaire Administration, Rose Geranium in Sesame Oil Nasal Spray
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo AdministrationDrug

    Instill isotonic nasal saline intranasally

  • Questionnaire AdministrationOther

    Ancillary studies

  • Rose Geranium in Sesame Oil Nasal SprayDrug

    Instill intranasally

Study groups in NCT04620369
Study groupRoleWhat they receive
Arm A (rose geranium in sesame oil nasal spray)ExperimentalPatients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.
Receives: Other: Questionnaire Administration; Drug: Rose Geranium in Sesame Oil Nasal Spray
Arm B (isotonic nasal saline)Placebo comparatorPatients 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.
Receives: Drug: Placebo Administration; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 2 weeks after initiating the nasal spray

Secondary outcomes (3)

  1. 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.

    Measured: Up to 2 weeks after initiating the nasal spray

  2. 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.

    Measured: Up to 2 weeks after initiating the nasal spray

  3. 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.

    Measured: Up to 2 weeks after initiating the nasal spray

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2020
  2. Study start13 Nov 2020
  3. Primary completion15 Dec 2022
  4. Study completion15 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04620369
Sponsor's protocol ID
MC19C1
Other IDs
NCI-2020-08287
Status last verified
Oct 2023
First submitted
27 Oct 2020
Last updated
3 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 38789656

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