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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IISupportive care, TreatmentClosed18 and overNCI, OtherRTOG 1012
CDR0000690182, NCI-2011-02620, NCT01262560

Trial Description

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.

Further Study Information

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 chemotherapy and radiation therapy for lung cancer) as compared to standard supportive treatment, as measured at week 4 by Numerical Rating Pain Scale (NRPS) for pain upon swallowing.

Secondary

  • Evaluate the trend of severity of radiation esophagitis-related pain during combined chemotherapy and radiation therapy for lung cancer using weekly measurements of the NRPS.
  • Evaluate the adverse events associated with Manuka honey, as measured by CTCAE, v. 4.
  • Evaluate the severity of radiation esophagitis (grade 3-4, CTCAE, v. 4).
  • Assess weight loss (percent weight change from baseline to 4 weeks).
  • Assess quality of life (QOL) and pain, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-30) global QOL score and pain symptom subscale.
  • Assess patient-reported dysphagia via a daily patient log.
  • Assess nutritional status, as measured by the mean change in serum prealbumin levels from baseline to 4 weeks.
  • Assess opioid use by collecting the patient's narcotic use in the previous 24-hour period at each weekly evaluation.
  • Evaluate patient-reported adverse events associated with Manuka honey using the PRO-CTCAE.

OUTLINE: This is a multicenter study. Patients are stratified according to the percentage of esophagus in the radiation field (V60 < 30% vs V60 ≥ 30%). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive standard supportive care for esophagitis-related pain as needed during chemoradiotherapy.
  • Arm II: Patients swallow liquid Manuka honey slowly over 3-5 minutes. Patients must refrain from eating and drinking for 1 hour after administration. Treatment continues 4 times per day during chemoradiotherapy.
  • Arm III: Patients place Manuka honey lozenges in their mouth one at a time and swallow the honey as it dissolves (no chewing or swallowing it whole). Patients must refrain from eating and drinking for 1 hour after administration. Treatment continues 4 times per day during chemoradiotherapy.

Patients complete quality of life, pain swallowing diary, and pain assessments (Numerical Rating Pain Scale, EORTC ALA-30 and Pain Subscale, and PRO-CTCAE) periodically during study treatment.

Patients are followed up at 12 weeks from the start of study treatment.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

NRG Oncology

Lawrence B. Berk, MD, PhDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01262560
ClinicalTrials.gov processed this data on October 20, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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