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Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Dysphagia, Lung Cancer, Pain, Esophagitis

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Trial Information

Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer



- 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


- Evaluate the trend of severity of radiation esophagitis-related pain during combined
chemotherapy and radiation therapy for lung cancer using weekly measurements of the

- 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

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

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

Inclusion Criteria


- 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


- Able to swallow thick liquids prior to treatment

- Able to complete required forms (verbal completion is adequate)

- No patients with poorly controlled diabetes

- No known hypersensitivity to honey


- 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

- Amifostine is not permitted

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Radiation esophagitis-related pain, 4 weeks from the start of treatment as measured by the Numerical Rating Pain Scale for pain on swallowing (NRPS)

Outcome Time Frame:

Baseline and 4 weeks from the start of treatment

Safety Issue:


Principal Investigator

Lawrence B. Berk, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tampa General Hospital, University of South Florida


United States: Food and Drug Administration

Study ID:

RTOG 1012



Start Date:

February 2012

Completion Date:

Related Keywords:

  • Dysphagia
  • Lung Cancer
  • Pain
  • Esophagitis
  • pain
  • dysphagia
  • recurrent non-small cell lung cancer
  • stage IA non-small cell lung cancer
  • stage IB non-small cell lung cancer
  • stage IIA non-small cell lung cancer
  • stage IIB non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • extensive stage small cell lung cancer
  • limited stage small cell lung cancer
  • recurrent small cell lung cancer
  • esophagitis
  • Deglutition Disorders
  • Esophagitis
  • Lung Neoplasms



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