Clinical trial NCT01262560
Conditions: Dysphagia Lung Cancer Pain Esophagitis
Keywords: pain dysphagia recurrent non-small cell lung cancer stage IA non-small cell lung cancer stage IB non-small cell lung cancer stage IIA non-small cell lung cancer stage IIB non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer esophagitis
Sponsor: Radiation Therapy Oncology Group
Start date: 2012-02-01; Completion date: 2014-11-01
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Standard supportive care arm 2: Manuka honey in liquid form arm 3: Manuka honey in lozenge form
Interventions: intervention 1: Manuka honey in liquid form intervention 2: Manuka honey in lozenge form intervention 3: Standard supportive care
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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.

Protocol documents: