View Cancer Clinical Trials
Phase II Randomized Trial Of Prophylactic Manuka Honey For The Reduction Of Chemoradiation Therapy Induced Esophagitis-Related Pain During The Treatment Of Lung Cancer
|North Coast Cancer
- Primary Objective
- 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 Objective
- 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 EORTC 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 PROCTCAE
- 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]
- Note: Patients can receive chemoradiotherapy while enrolled on an RTOG lung trial or while not enrolled on an RTOG lung trial. Patients cannot receive chemoradiotherapy while enrolled on a single institution trial or trials coordinated by other cooperative groups [to increase the homogeneity of the population]
- At least 5 cm of the esophagus must be in the 60 Gy isodose volume in 1.6 to 2.0 Gy fractions [to insure that there is a significant risk for esophagitis among the patients]
- Age ≥ 18 [RTOG standard]
- Patients must speak English or Spanish in order to complete the mandatory EORTC QLQ-30 and PRO-CTCAE, which are only available in certain languages.
- Patients with metastatic disease [to increase the homogeneity of the population]
- Patients with an inability to swallow thick liquids prior to treatment [to insure that the patient will be able to swallow the honey]
- Patients with a known hypersensitivity to honey [to avoid unnecessary toxicity]
- Patients not receiving chemotherapy [to increase the homogeneity of the population]
- Patients receiving more than once-daily treatments [to increase the homogeneity of the population]
- Patients who have received prior chemotherapy or radiation therapy [to increase the homogeneity of the population]
- Patients unable to complete the required forms; however, verbal completion is adequate if recorded on the form daily [patient-reported pain is the primary endpoint]
- Diabetes is not a contraindication to study enrollment, but patients with poorly controlled diabetes should not be enrolled
Cancer Answers & Appointments
Speak with a cancer nurse specialist for appointment assistance and for answers to your questions about cancer locally at 216.444.7923 or toll-free 1.866.223.8100.
Monday through Friday from 8 a.m. – 4:30 p.m. (ET).
Resources for medical professionals
- Outpatient appointment referrals: 216.444.7923 or 866.223.8100
- Inpatient hospital transfers: 800.553.5056
- Referring Physician Concierge: 216.444.6196 or 216.312.4910.
Search available cancer clinical trials by disease, hospital, phase or number.
This information is provided by Cleveland Clinic and is not intended to replace
the medical advice of your doctor or health care provider.
Please consult your health care provider for advice about a specific medical condition.
© Copyright 2015 Cleveland Clinic. All rights reserved.