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Liquid Manuka Honey for Esophagitis
Phase 2
Waitlist Available
Led By Lawrence B. Berk, MD, PhD
Research Sponsored by Radiation Therapy Oncology Group
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 baseline, 4 and 12 weeks from the start of treatment
Awards & highlights
Study Summary
RATIONALE: Manuka honey may prevent or reduce esophagitis-related pain caused by chemotherapy and radiation therapy. It is not yet known whether Manuka honey is more effective than standard care in preventing pain. PURPOSE: This randomized phase II clinical trial is studying Manuka honey to see how well it works in preventing esophagitis-related pain in patients receiving chemotherapy and radiation therapy for lung cancer.
Eligible Conditions
- Esophagitis
- Lung Cancer
- Pain
- Swallowing Difficulty
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 and 12 weeks from the start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 and 12 weeks from the start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS)
Secondary outcome measures
Adverse Events Associated With Manuka Honey Using CTCAE v4.0
Dysphagia Via Daily Patient Log
Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks)
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Lozenge Manuka HoneyExperimental Treatment1 Intervention
Manuka honey in lozenge form
Group II: Liquid Manuka HoneyExperimental Treatment1 Intervention
Manuka honey in liquid form
Group III: Supportive CareActive Control1 Intervention
Standard supportive care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Honey
FDA approved
Honey
FDA approved
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Who is running the clinical trial?
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,764 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,566 Total Patients Enrolled
4 Trials studying Esophagitis
336 Patients Enrolled for Esophagitis
NRG OncologyOTHER
232 Previous Clinical Trials
100,616 Total Patients Enrolled
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