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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
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