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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01262560
First received: December 16, 2010
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Dysphagia
Lung Cancer
Pain
Esophagitis
Drug: Manuka honey
Drug: Viscous lidocaine and magnesium aluminum oxide (Maalox®); Liquid or solid oxycodone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Radiation esophagitis-related pain, 4 weeks from the start of treatment as measured by the Numerical Rating Pain Scale for pain on swallowing (NRPS) [ Time Frame: Baseline and 4 weeks from the start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiation esophagitis during treatment as measured weekly during treatment and 12 weeks from the start of treatment by the NRPS [ Time Frame: Weekly during treatment and 12 weeks from the start of treatment ] [ Designated as safety issue: No ]
  • Dysphagia via daily patient log [ Time Frame: Weekly during treatment and 12 weeks from the start of treatment ] [ Designated as safety issue: No ]
  • Quality of life and pain, as measured by the EORTC QLQ-30 global QOL score and pain symptom subscale at 4 and 12 weeks [ Time Frame: Baseline, 4 and 12 weeks from the start of treatment ] [ Designated as safety issue: No ]
  • Radiation esophagitis grade 3-4 (CTCAE, v. 4) [ Time Frame: Until 12 weeks from the start of treatment ] [ Designated as safety issue: No ]
  • Weight loss (percent change from baseline to 4 weeks) [ Time Frame: Baseline and 4 weeks from the start of treatment ] [ Designated as safety issue: No ]
  • Nutritional status (change in serum prealbumin levels from baseline to 4 weeks) [ Time Frame: Baseline and 4 weeks from the start of treatment ] [ Designated as safety issue: No ]
  • Opioid use [ Time Frame: Baseline, weekly during treatment and 12 weeks from the start of treatment ] [ Designated as safety issue: No ]
  • Adverse events associated with Manuka honey using CTCAE, v. 4 [ Time Frame: Until 12 weeks from the start of treatment ] [ Designated as safety issue: Yes ]
  • Patient reported adverse events associated with Manuka honey using the PRO-CTCAE [ Time Frame: Baseline, 4 and 12 weeks from the start of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Maalox®; Liquid or solid oxycodone
Arm 1: Standard supportive care (Viscous lidocaine and magnesium aluminum oxide (Maalox®); Liquid or solid oxycodone)
Drug: Viscous lidocaine and magnesium aluminum oxide (Maalox®); Liquid or solid oxycodone
Standard supportive care
Experimental: Arm 2: Liquid Manuka honey
Arm 2: Liquid Manuka honey
Drug: Manuka honey
Experimental: Arm 3: Lozenge Manuka honey
Arm 3: Lozenge Manuka honey
Drug: Manuka honey

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262560

  Show 59 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Lawrence B. Berk, MD, PhD Tampa General Hospital, University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01262560     History of Changes
Other Study ID Numbers: RTOG 1012, RTOG-1012, CDR0000690182, NCI-2011-02620
Study First Received: December 16, 2010
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiation Therapy Oncology Group:
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

Additional relevant MeSH terms:
Deglutition Disorders
Esophagitis
Lung Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Gastroenteritis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Lidocaine
Oxycodone
Aluminum hydroxide, magnesium hydroxide, drug combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014