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Author Notes:

Corresponding author: Shannon E. Fogh MD, Department of Radiation Oncology, University of California San Francisco, 505 Parnassus Ave, Room L-08, Box 0226, San Francisco, CA 94143, Office: 415-353-8950, Fax: 415-353-8679, Shannon.Fogh@ucsf.edu.

This work was presented at the 2014 American Society of Radiation Oncology (ASTRO), 56th Annual Meeting, San Francisco.

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Research Funding:

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:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Oncology
  • Radiology, Nuclear Medicine & Medical Imaging
  • PATIENT-REPORTED OUTCOMES
  • ANTIBACTERIAL ACTIVITY
  • RADIATION-THERAPY
  • CONCURRENT CHEMOTHERAPY
  • CLOSTRIDIUM-BOTULINUM
  • MULTIVARIATE-ANALYSIS
  • CLINICAL-TRIALS
  • TOPICAL HONEY
  • RADIOTHERAPY
  • AMIFOSTINE

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

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Journal Title:

International Journal of Radiation Oncology - Biology - Physics

Volume:

Volume 97, Number 4

Publisher:

, Pages 786-796

Type of Work:

Article | Post-print: After Peer Review

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.

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© 2017 Elsevier Inc. All rights reserved.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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