|Phase II||Supportive care, Treatment||Closed||18 and over||NCI, Other||RTOG 1012|
CDR0000690182, NCI-2011-02620, NCT01262560
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.
Further Study Information
- 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.
- 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.
- 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
- 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
Trial Lead Organizations/Sponsors
Radiation Therapy Oncology GroupNational Cancer Institute
|Lawrence B. Berk, MD, PhD||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01262560
ClinicalTrials.gov processed this data on January 12, 2014
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