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

• Radiation esophagitis-related pain, 4 weeks from the start of treatment as measured by the Numerical Rating Pain Scale for pain on swallowing (NRPS) [ Time Frame: Baseline and 4 weeks from the start of treatment ] [ Designated as safety issue: No ]
  

• Radiation esophagitis during treatment as measured weekly during treatment and 12 weeks from the start of treatment by the NRPS [ Time Frame: Weekly during treatment and 12 weeks from the start of treatment ] [ Designated as safety issue: No ]
  
• Dysphagia via daily patient log [ Time Frame: Weekly during treatment and 12 weeks from the start of treatment ] [ Designated as safety issue: No ]
  
• Quality of life and pain, as measured by the EORTC QLQ-30 global QOL score and pain symptom subscale at 4 and 12 weeks [ Time Frame: Baseline, 4 and 12 weeks from the start of treatment ] [ Designated as safety issue: No ]
  
• Radiation esophagitis grade 3-4 (CTCAE, v. 4) [ Time Frame: Until 12 weeks from the start of treatment ] [ Designated as safety issue: No ]
  
• Weight loss (percent change from baseline to 4 weeks) [ Time Frame: Baseline and 4 weeks from the start of treatment ] [ Designated as safety issue: No ]
  
• Nutritional status (change in serum prealbumin levels from baseline to 4 weeks) [ Time Frame: Baseline and 4 weeks from the start of treatment ] [ Designated as safety issue: No ]
  
• Opioid use [ Time Frame: Baseline, weekly during treatment and 12 weeks from the start of treatment ] [ Designated as safety issue: No ]
  
• Adverse events associated with Manuka honey using CTCAE, v. 4 [ Time Frame: Until 12 weeks from the start of treatment ] [ Designated as safety issue: Yes ]
  
• Patient reported adverse events associated with Manuka honey using the PRO-CTCAE [ Time Frame: Baseline, 4 and 12 weeks from the start of treatment ] [ Designated as safety issue: Yes ]
  

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 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 ALA-30 and Pain Subscale, and PRO-CTCAE) periodically during study treatment.

Patients are followed up at 12 weeks from the start of study treatment.