NCT01262560

Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer

Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Manuka honey may prevent or reduce esophagitis-related pain caused by chemotherapy and radiation therapy. It is not yet known whether Manuka honey is more effective than standard care in preventing pain. PURPOSE: This randomized phase II clinical trial is studying Manuka honey to see how well it works in preventing esophagitis-related pain in patients receiving chemotherapy and radiation therapy for lung cancer.

Detailed description

OBJECTIVES: Primary * Evaluate the relative efficacy of 4 times a day consumption of liquid or lozenge Manuka honey to delay or prevent radiation esophagitis-related pain (during combined chemotherapy and radiation therapy for lung cancer) as compared to standard supportive treatment, as measured at week 4 by Numerical Rating Pain Scale (NRPS) for pain upon swallowing. Secondary * Evaluate the trend of severity of radiation esophagitis-related pain during combined chemotherapy and radiation therapy for lung cancer using weekly measurements of the NRPS. * Evaluate the adverse events associated with Manuka honey, as measured by CTCAE, v. 4. * Evaluate the severity of radiation esophagitis (grade 3-4, CTCAE, v. 4). * Assess weight loss (percent weight change from baseline to 4 weeks). * Assess quality of life (QOL) and pain, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-30) global QOL score and pain symptom subscale. * Assess patient-reported dysphagia via a daily patient log. * Assess nutritional status, as measured by the mean change in serum prealbumin levels from baseline to 4 weeks. * Assess opioid use by collecting the patient's narcotic use in the previous 24-hour period at each weekly evaluation. * Evaluate patient-reported adverse events associated with Manuka honey using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). OUTLINE: This is a multicenter study. Patients are stratified according to the percentage of esophagus in the radiation field (V60 \< 30% vs V60 ≥ 30%). Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive standard supportive care for esophagitis-related pain as needed during chemoradiotherapy. * Arm II: Patients swallow liquid Manuka honey slowly over 3-5 minutes. Patients must refrain from eating and drinking for 1 hour after administration. Treatment continues 4 times per day during chemoradiotherapy. * Arm III: Patients place Manuka honey lozenges in their mouth one at a time and swallow the honey as it dissolves (no chewing or swallowing it whole). Patients must refrain from eating and drinking for 1 hour after administration. Treatment continues 4 times per day during chemoradiotherapy. Patients complete quality of life, pain swallowing diary, and pain assessments (Numerical Rating Pain Scale, EORTC QLQ-30 and Pain Subscale, and PRO-CTCAE) periodically during study treatment. Patients are followed up at 12 weeks from the start of study treatment.

Conditions

• Dysphagia
• Lung Cancer
• Pain
• Esophagitis

Interventions

Type	Name	Description
DRUG	Manuka honey in liquid form	Patients swallow 10 cc (approximately 2 level teaspoons) of liquid Manuka honey 4 times per day while awake over an approximately 12 hour period (e.g. 8 a.m., Noon, 4 p.m., and 8 p.m.) 7 days/week during concurrent chemotherapy and radiation treatment.
DRUG	Manuka honey in lozenge form	Patients place 2 lozenges (the equivalent of 10 cc of liquid Manuka honey), one at a time, in the mouth, allowing each lozenge to dissolve on the tongue/in the mouth, swallowing the honey as it dissolves. Patients do this 4 times per day while awake over an approximately 12 hour period (e.g. 8 a.m., Noon, 4 p.m., and 8 p.m.) 7 days/week during concurrent chemotherapy and radiation treatment.
DRUG	Standard supportive care	Patients receive standard supporting care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment. The following regimen is recommended, but the local standard of care is permitted. 1. A compound containing viscous lidocaine and magnesium aluminum oxide (Maalox®); 2. Liquid or solid oxycodone, 5-10 mg, every 3 hours as needed.

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-02-01
• Completion: 2014-11-01
• First posted: 2010-12-17
• Last updated: 2017-08-31
• Results posted: 2017-08-31

Locations

59 sites across 1 country: United States