Phase 2
Completed N=163
Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer
Source: ClinicalTrials.gov NCT01262560 ↗Enrolled (actual)
163
Serious AEs
25.7%
Results posted
Aug 2017
Primary outcomePrimary: Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS) — 1; 1; 1 units on a scale — p=0.92
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS) |
1; 1; 1 | 0.92 |
| SECONDARY Radiation Esophagitis-related Pain During Treatment as Measured During Treatment and 12 Weeks by the Numerical Rating Pain Scale (NRPS) |
0; 0; 0; 0; 0; 0 | 0.87 |
| SECONDARY Dysphagia Via Daily Patient Log |
1; 1; 1; 1; 1; 1 | 0.70 |
| SECONDARY Quality of Life and Pain, as Measured by the EORTC QLQ-30 Global QOL Score and Pain Symptom Subscale at 4 and 12 Weeks |
66.67; 66.67; 66.67; 16.67; 16.67; 16.67 | 0.086 |
| SECONDARY Percentage of Participants With Radiation Esophagitis Grade 3-4 (CTCAE v. 4) |
12.5; 2.0; 6.0 | 0.06 |
| SECONDARY Percent Change in Weight From Baseline to 4 Weeks |
-2.22; -0.62; -2.64 | 0.53 |
| SECONDARY Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks) |
-3.34; 5.25; 0.17 | 0.20 |
| SECONDARY Percentage of Patients Using Opioids |
13.2; 9.4; 13.0; 37.0; 14.3; 29.2 | — |
| SECONDARY Adverse Events Associated With Manuka Honey Using CTCAE v4.0 |
6.3; 16.0; 12.0; 20.8; 26.0; 18.0 | — |
| SECONDARY Patient Reported Difficulty in Swallowing Associated With Manuka Honey Using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) |
1; 1; 1 | 0.39 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01262560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.