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

• Type of Material: Article
• Authors: Shannon Fogh, University of California San Francisco; Snehal Deshmukh, NRG Oncology Statistics and Data Management Center; Lawrence B. Berk, University of South Florida; Amylou C. Dueck, Mayo Clinic in Arizona; Kevin Roof, Southeast Cancer Control Consortium, Inc.; Sherif Yacoub, York Cancer Center; Thomas Gergel, Geisinger Medical Center; Kevin Stephans, Cleveland Clinic Foundation; Andreas Rimner, Memorial Sloan Kettering Cancer Center; Albert DeNittis, Main Line CCOP; John Pablo, Lewis Cancer & Research Pavilion at St. Joseph's/Candler; Justin Rineer, UF Health Cancer Center – Orlando Health; Terence M. Williams, Ohio State University; Deborah W. Bruner, Emory University
• Language: English
• Date: 2017-03-15
• Publisher: Elsevier
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2017 Elsevier Inc. All rights reserved.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.ijrobp.2016.11.022
• Title of Journal or Parent Work: International Journal of Radiation Oncology - Biology - Physics
• ISSN: 0360-3016
• Volume: 97
• Issue: 4
• Start Page: 786
• End Page: 796
• Grant/Funding Information: This project was supported by grants U10CA37422 (CCOP), U10CA21661 (RTOG-Ops-Stat), U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), UG1CA189867 (NCORP), and HHSN261200800043C/HHSN261201000063C (PRO-CTCAE) from the National Cancer Institute (NCI).
• Keywords: ANTIBACTERIAL ACTIVITY; Science & Technology; CLOSTRIDIUM-BOTULINUM; Life Sciences & Biomedicine; PATIENT-REPORTED OUTCOMES; RADIOTHERAPY; Radiology, Nuclear Medicine & Medical Imaging; CLINICAL-TRIALS; AMIFOSTINE; Oncology; CONCURRENT CHEMOTHERAPY; RADIATION-THERAPY; MULTIVARIATE-ANALYSIS; TOPICAL HONEY
• Research Categories: Health Sciences, General; Health Sciences, Oncology; Health Sciences, Radiology

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.