drugset / Trial / NCT01262560
Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer
Phase 2
Completed
163 enrolled
Radiation Therapy Oncology Group
NRG Oncology · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2012-02
- Primary completion
- 2014-02
- Completion
- 2014-11
Outcome
Missed primary endpoint
registry Supportive Care vs Liquid Manuka Honey; p = 0.92 NCT01262560 ↗
registry Supportive Care vs Lozenge Manuka Honey; p = 0.93 NCT01262560 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Manuka honey | Traditional medicine (herbal / TCM) | 10 ml | Oral |
| Comparator | Lidocaine | Other / unclassified | — | — |
| Comparator | Oxycodone | Other / unclassified | 5 mg | — |
| Comparator | Oxycodone | Other / unclassified | 10 mg | — |
| Comparator | magnesium aluminum oxide | Unknown | — | — |