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

Pain Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Esophagitis
• Lung Cancer
• Lung Neoplasms
• Pain

• NCT number: NCT01262560
• Study type: Interventional
• Source: Radiation Therapy Oncology Group
• Status: Completed
• Phase: Phase 2
• Start date: February 2012
• Completion date: November 2014