Details

Details

Title Phase II Randomized Trial Of Prophylactic Manuka Honey For The Reduction Of Chemoradiation Therapy Induced Esophagitis-Related Pain During The Treatment Of Lung Cancer

IRB RTOG 1012

CC 12-494

Hospital Fairview, Hillcrest, Independence, Main Campus, North Coast Cancer, Strongsville, Wooster

Phase Phase 2

Disease Lung

Description

Description

  1. 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.
  2. 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
Inclusion Criteria

Inclusion Criteria

  1. 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]
  2. 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]
  3. Age ≥ 18 [RTOG standard]
  4. 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.
Exclusion Criteria

Exclusion Criteria

  1. Patients with metastatic disease [to increase the homogeneity of the population]
  2. Patients with an inability to swallow thick liquids prior to treatment [to insure that the patient will be able to swallow the honey]
  3. Patients with a known hypersensitivity to honey [to avoid unnecessary toxicity]
  4. Patients not receiving chemotherapy [to increase the homogeneity of the population]
  5. Patients receiving more than once-daily treatments [to increase the homogeneity of the population]
  6. Patients who have received prior chemotherapy or radiation therapy [to increase the homogeneity of the population]
  7. 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]
  8. Diabetes is not a contraindication to study enrollment, but patients with poorly controlled diabetes should not be enrolled