Rose Geranium in Sesame Oil Nasal Spray for Nasal Vestibulitis

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 weeks after initiating the nasal spray for reporting.

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

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