Trial Information

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

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.