Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI); NRG Oncology
• Treatments: Aluminum hydroxide, magnesium hydroxide, drug combination; Lidocaine; Oxycodone

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