Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT04620369
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04620369
Study Brief:
Protocol Section:
NCT04620369