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Rose Geranium in Sesame Oil Nasal Spray for the Improvement of Nasal Vestibulitis Symptoms in Cancer Patients Receiving Chemotherapy
Phase 3
Waitlist Available
Led By Charles L Loprinzi
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 weeks after initiating the nasal spray
Awards & highlights
Pivotal Trial
Summary
This trial is testing a nasal spray made from rose geranium and sesame oil on cancer patients undergoing chemotherapy. These patients often have nasal vestibulitis, which causes dryness and sores in the nose. The spray is believed to help by reducing inflammation and soothing the nasal passages. Rose geranium essential oil has been studied for its anti-inflammatory properties, and sesame oil has been shown to increase ciliary beat frequency in nasal mucosa.
Eligible Conditions
- Nasal Vestibulitis
- Blood Cancers
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 weeks after initiating the nasal spray
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 weeks after initiating the nasal spray
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response
Secondary study objectives
Incidence of adverse events (AEs)
Palliative Care
Severity of most prominent nasal symptom indicated at baseline
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A (rose geranium in sesame oil nasal spray)Experimental Treatment2 Interventions
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.
Group II: Arm B (isotonic nasal saline)Placebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rose Geranium in Sesame Oil Nasal Spray
2020
Completed Phase 3
~60
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,060,964 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,111 Total Patients Enrolled
Charles L LoprinziPrincipal InvestigatorMayo Clinic in Rochester
3 Previous Clinical Trials
4 Total Patients Enrolled