RTOG 1012 - PHASE II RANDOMIZED TRIAL OF PROPHYLACTIC MANUKA HONEY FOR THE REDUCTION OF CHEMORADIATION THERAPY INDUCED ESOPHAGITIS- RELATED PAIN DURING THE TREATMENT OF LUNG CANCER
This randomized phase II trial is studying studying Manuka honey to see how well it works in preventing esophagitis-related pain in patients receiving chemotherapy and radiation therapy for lung cancer.
Age > 18 years.
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 enrolled on an RTOG lung trial or while not enrolled on an RTOG lung trial. Patients cannot receive chemoradiotherapy while enrolled on a single institution trial or trials coordinated by other cooperative groups [to increase the homogeneity of the population].
At least 5 cm of the esophagus must be in the 60 Gy isodose volume in 1.6 to 2.0 Gy fractions [to insure that there is a significant risk for esophagitis among the patients];
Patients must provide study specific informed consent prior to study entry.
Patients with metastatic disease [to increase the homogeneity of the population];
Patients with an inability to swallow thick liquids prior to treatment [to insure that the patient will be able to swallow the honey];
Patients with a known hypersensitivity to honey [to avoid unnecessary toxicity];
Patients not receiving chemotherapy [to increase the homogeneity of the population];
Patients receiving more than once-daily treatments [to increase the homogeneity of the population];
Patients who have received prior chemotherapy or radiation therapy [to increase the homogeneity of the population];
Patients unable to complete the required forms; however, verbal completion is adequate if recorded on the form daily [patient-reported pain is the primary endpoint];
Diabetes is not a contraindication to study enrollment, but patients with poorly controlled diabetes should not be enrolled.
Dr. John A. Pablo
Nancy N. and J.C. Lewis Cancer & Research Pavilion225 Candler Drive, Savannah, Georgia 31405