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.

Shannon E Fogh, Snehal Deshmukh, Lawrence B Berk, Amylou C Dueck, Kevin Roof, Sherif Yacoub, Thomas Gergel, Kevin Stephans, Andreas Rimner, Albert DeNittis, John Pablo, Justin Rineer, Terence M Williams, Deborah Bruner

Journal: International journal of radiation oncology, biology, physics 2017;97(4):786-796

PMID: 28244415

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Abstract

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.

Address: University of California San Francisco, San Francisco, California. Electronic address: [email protected].; NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.; University of South Florida, Tampa, Florida.; Mayo Clinic in Arizona, Scottsdale, Arizona.; Southeast Cancer Control Consortium, Inc, CCOP, Winston-Salem, North Carolina.; York Cancer Center, York, Pennsylvania.; Geisinger Medical Center CCOP, Danville, Pennsylvania.; Cleveland Clinic Foundation, Cleveland, Ohio.; Memorial Sloan Kettering Cancer Center, New York, New York.; Main Line CCOP, Wynnewood, Pennsylvania.; Lewis Cancer & Research Pavilion at St. Joseph's/Candler, Savannah, Georgia.; UF Health Cancer Center - Orlando Health, Orlando, Florida.; Ohio State University Medical Center, Columbus, Ohio.; Emory University, Atlanta, Georgia.

DOI: 10.1016/j.ijrobp.2016.11.022

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MeSH Terms: Aged, Chemoradiotherapy, Diet Therapy, Esophagitis, Female, Honey, Humans, Leptospermum, Lung Neoplasms, Male, Middle Aged, Radiation Injuries, Treatment Outcome