manuka honey in preventing esophagitis-related pain in patients receiving chemotherapy and radiation therapy for lung cancer

Conditions: Dysphagia; Lung Cancer; Pain; Esophagitis

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.

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.

Eligibility criteria:
disease characteristics: * patients being treated with combination chemotherapy (definitive or adjuvant) and radiation therapy once daily for small cell or non-small cell lung cancer (primary population for the trial) * patients can receive chemoradiotherapy while on a radiation therapy oncology group (rtog) lung trial or while not being on a clinical trial * no patients receiving chemoradiotherapy while enrolled on a single institution trial or trials coordinated by other cooperative groups * no patients with metastatic disease * at least 5 cm of the esophagus must be in the 60 gy isodose volume in 1.6 to 2.0 gy fractions patient characteristics: * age 18 and up * able to swallow thick liquids prior to treatment * able to speak english or spanish in order to complete required forms (verbal completion is adequate) * no patients with poorly controlled diabetes * no known hypersensitivity to honey prior concurrent therapy: * see disease characteristics * no patients who have received prior chemotherapy or radiation therapy * no patients receiving more than once daily treatments * therapeutic use of honey other than the manuka honey provided for this trial is not allowed while patients are on study * patients must also avoid honey-flavored medical products and/or sugary, viscous substances * amifostine is not permitted

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