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Not Recruiting
Trial ID: NCT01262560
Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer
Professor of Radiation Oncology (Radiation Therapy)
Clinical Associate Professor, Medicine - Oncology
Professor of Medicine (Oncology)
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
Associate Professor of Medicine (Oncology)
Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)
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
drug: Manuka honey in liquid form
drug: Manuka honey in lozenge form
drug: Standard supportive care
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061