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:
Collaborators:
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01262560
First received: December 16, 2010
Last updated: July 9, 2014
Last verified: July 2014

December 16, 2010
July 9, 2014
February 2012
April 2016   (final data collection date for primary 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) [ Time Frame: Baseline and 4 weeks from the start of treatment ] [ Designated as safety issue: No ]
Radiation esophagitis-related pain, 4 weeks from the start of treatment as measured by the Numerical Rating Pain Scale for pain on swallowing (NRPS) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01262560 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Radiation esophagitis during treatment as measured weekly during treatment and 12 weeks from the start of treatment by the NRPS [ Designated as safety issue: No ]
  • Dysphagia via daily patient log [ 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 [ Designated as safety issue: No ]
  • Radiation esophagitis grade 3-4 (CTCAE, v. 4) [ Designated as safety issue: No ]
  • Weight loss (percent change from baseline to 4 weeks) [ Designated as safety issue: No ]
  • Nutritional status (change in serum prealbumin levels from baseline to 4 weeks) [ Designated as safety issue: No ]
  • Opioid use [ Designated as safety issue: No ]
  • Adverse events associated with Manuka honey using CTCAE, v. 4 [ Designated as safety issue: Yes ]
  • Patient reported adverse events associated with Manuka honey using the PRO-CTCAE [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer
Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Dysphagia
  • Lung Cancer
  • Pain
  • Esophagitis
  • Drug: Manuka honey
  • Drug: Viscous lidocaine and magnesium aluminum oxide (Maalox®); Liquid or solid oxycodone
    Standard supportive care
  • 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)
    Intervention: Drug: Viscous lidocaine and magnesium aluminum oxide (Maalox®); Liquid or solid oxycodone
  • Experimental: Arm 2: Liquid Manuka honey
    Arm 2: Liquid Manuka honey
    Intervention: Drug: Manuka honey
  • Experimental: Arm 3: Lozenge Manuka honey
    Arm 3: Lozenge Manuka honey
    Intervention: Drug: Manuka honey
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
163
Not Provided
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01262560
RTOG 1012, RTOG-1012, CDR0000690182, NCI-2011-02620
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
  • National Cancer Institute (NCI)
  • NRG Oncology
Principal Investigator: Lawrence B. Berk, MD, PhD Tampa General Hospital, University of South Florida
Radiation Therapy Oncology Group
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP