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Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer
Not Recruiting
Trial ID: NCT01262560
Purpose
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.
Official Title
Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer
Stanford Investigator(s)
Billy W Loo, Jr, MD PhD FASTRO FACR
Professor of Radiation Oncology (Radiation Therapy)
Kavitha Ramchandran
Clinical Associate Professor, Medicine - Oncology
Heather Wakelee
Professor of Medicine (Oncology)
Quynh-Thu Le, MD
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Maximilian Diehn, MD, PhD
Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)
Eligibility
DISEASE CHARACTERISTICS:
- Patients being treated with combination chemotherapy (definitive or adjuvant) and
radiation therapy once daily for small cell or non-small cell lung cancer (primary
population for the trial)
- Patients can receive chemoradiotherapy while on a Radiation Therapy Oncology
Group (RTOG) lung trial or while not being on a clinical trial
- No patients receiving chemoradiotherapy while enrolled on a single institution
trial or trials coordinated by other cooperative groups
- No patients with metastatic disease
- At least 5 cm of the esophagus must be in the 60 Gy isodose volume in 1.6 to 2.0 Gy
fractions
PATIENT CHARACTERISTICS:
- Age 18 and up
- Able to swallow thick liquids prior to treatment
- Able to speak English or Spanish in order to complete required forms (verbal
completion is adequate)
- No patients with poorly controlled diabetes
- No known hypersensitivity to honey
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No patients who have received prior chemotherapy or radiation therapy
- No patients receiving more than once daily treatments
- Therapeutic use of honey other than the Manuka honey provided for this trial is not
allowed while patients are on study
- Patients must also avoid honey-flavored medical products and/or sugary, viscous
substances
- Amifostine is not permitted
Intervention(s):
drug: Manuka honey in liquid form
drug: Manuka honey in lozenge form
drug: Standard supportive care
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061