Status:
COMPLETED
Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
NRG Oncology
Conditions:
Dysphagia
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pr...
Detailed Description
OBJECTIVES: Primary * 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 chemothera...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT01262560
Start Date
February 1 2012
End Date
November 1 2014
Last Update
August 31 2017
Active Locations (59)
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1
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States, 36608
2
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
3
Stanford Cancer Center
Stanford, California, United States, 94305-5824
4
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713