A Randomized Phase 2 Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy-Induced Esophagitis During the Treatment of Lung Cancer: Results of NRG Oncology RTOG 1012.

PURPOSE: Randomized trials have shown that honey is effective for the prevention of radiation-induced mucositis in head and neck cancer patients. Because there is no efficacious preventative for radiation esophagitis in lung cancer patients, this trial compared liquid honey, honey lozenges, and standard supportive care for radiation esophagitis. METHODS: The patients were stratified by percentage of esophagus receiving specific radiation dose (V60 Gy esophagus <30% or ≥30%) and were then randomized between supportive care, 10 mL of liquid manuka honey 4 times a day, and 2 lozenges (10 mL of dehydrated manuka honey) 4 times a day during concurrent chemotherapy and radiation therapy. The primary endpoint was patient-reported pain on swallowing, with the use of an 11-point (0-10) scale at 4 weeks (Numerical Rating Pain Scale, NRPS). The study was designed to detect a 15% relative reduction of change in NRPS score. The secondary endpoints were trend of pain over time, opioid use, clinically graded and patient-reported adverse events, weight loss, dysphagia, nutritional status, and quality of life. RESULTS: 53 patients were randomized to supportive care, 54 were randomized to liquid honey, and 56 were randomized to lozenge honey. There was no significant difference in the primary endpoint of change in the NRPS at 4 weeks between arms. There were no differences in any of the secondary endpoints except for opioid use at 4 weeks during treatment between the supportive care and liquid honey arms, which was found to be significant (P=.03), with more patients on the supportive care arm taking opioids. CONCLUSION: Honey as prescribed within this protocol was not superior to best supportive care in preventing radiation esophagitis. Further testing of other types of honey and research into the mechanisms of action are needed.

Primer on integrative oncology.

At the present time, there is no obvious answer for many of these design difficulties. This problem will continue to constrain ability to determine the efficacy of integrative medical techniques for patients who have cancer. Patients, however, will continue to gravitate toward alternative treatments, especially when standard cancer treatments fail. Therefore oncologists must be aware of alternative medical agents and techniques, and be able to guide their patients, rather than simply being dismissive.

Pathophysiology and management of radiation-induced xerostomia.

Radiotherapeutic treatment of head and neck cancer patients often causes long-term dysfunction involving their salivary function, swallowing capabilities, and taste. Salivary gland dysfunction from radiation therapy is often the most unpleasant side effect of treatment. This article will review current knowledge concerning the anatomy and function of glands involved with salivation, measurement of salivary gland function, surgical and pharmacologic prevention and treatment of xerostomia, and methods to administer radiation while causing the least amount of damage to salivary glands.