Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 31, 2017 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Supportive Care
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Radiation Therapy Oncology Group
- Interventions being studied
- Drug: Manuka honey in liquid form; Drug: Manuka honey in lozenge form; Drug: Standard supportive care
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Providence Cancer Center at Providence HospitalMobile, Alabama
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Stanford Cancer CenterStanford, California
- CCOP - Christiana Care Health ServicesNewark, Delaware
- Baptist Cancer Institute - JacksonvilleJacksonville, Florida
- CCOP - Mount Sinai Medical CenterMiami Beach, Florida
- Florida Cancer Center - PalatkaPalatka, Florida
- Piedmont Fayette HospitalFayetteville, Georgia
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia
- Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii
- Hawaii Medical Center - EastHonolulu, Hawaii
- OSF St. Francis Medical CenterPeoria, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 31, 2017. Always confirm current availability with the study team.