Clinical trial NCT04620369: Rose Geranium in Sesame Oil Nasal Spray for the Improvement of Nasal Vestibulitis Symptoms in Cancer Patients Receiving Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Nasal Vestibulitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-11-09
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response
timeFrame: At 2 weeks after initiating the nasal spray
Secondary outcomes:
measure: Severity of most prominent nasal symptom indicated at baseline
timeFrame: Up to 2 weeks after initiating the nasal spray
measure: Nasal symptom analysis
timeFrame: Up to 2 weeks after initiating the nasal spray
measure: Incidence of adverse events (AEs)
timeFrame: Up to 2 weeks after initiating the nasal spray
Other outcomes:
Locations:
city: Albert Lea
country: United States
facility: Mayo Clinic Health System in Albert Lea
state: Minnesota
city: Brainerd
country: United States
facility: Essentia Health Saint Joseph's Medical Center
state: Minnesota
city: Deer River
country: United States
facility: Essentia Health - Deer River Clinic
state: Minnesota
city: Detroit Lakes
country: United States
facility: Essentia Health Saint Mary's - Detroit Lakes Clinic
state: Minnesota
city: Duluth
country: United States
facility: Essentia Health Cancer Center
state: Minnesota
city: Ely
country: United States
facility: Essentia Health Ely Clinic
state: Minnesota
city: Fosston
country: United States
facility: Essentia Health - Fosston
state: Minnesota
city: Grand Rapids
country: United States
facility: Fairview Grand Itasca Clinic &amp; Hospital
state: Minnesota
city: Hibbing
country: United States
facility: Essentia Health Hibbing Clinic
state: Minnesota
city: Hibbing
country: United States
facility: Fairview Range Medical Center
state: Minnesota
city: International Falls
country: United States
facility: Essentia Health - International Falls Clinic
state: Minnesota
city: Mankato
country: United States
facility: Mayo Clinic Health Systems-Mankato
state: Minnesota
city: Monticello
country: United States
facility: Monticello Cancer Center
state: Minnesota
city: Park Rapids
country: United States
facility: Essentia Health - Park Rapids
state: Minnesota
city: Princeton
country: United States
facility: Fairview Northland Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Sandstone
country: United States
facility: Essentia Health Sandstone
state: Minnesota
city: Thief River Falls
country: United States
facility: Sanford Thief River Falls Medical Center
state: Minnesota
city: Virginia
country: United States
facility: Essentia Health Virginia Clinic
state: Minnesota
city: Worthington
country: United States
facility: Sanford Cancer Center Worthington
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Charles L Loprinzi
role: PRINCIPAL_INVESTIGATOR
References: