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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01262560
First Posted: December 17, 2010
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
December 16, 2010
December 17, 2010
December 13, 2016
August 31, 2017
August 31, 2017
February 2012
February 2014   (Final data collection date for primary outcome measure)
Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS) [ Time Frame: Baseline and 4 weeks from the start of treatment ]
Esophagitis-related pain was measured using patient-reported pain on swallowing as assessed by the Numerical Rating Pain Scale (NRPS), an 11-point scale (0-10) in which 0 indicates no pain and 10 indicates the worst pain imaginable. Generally, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Change was calculated by subtracting the baseline value from the 4-week value. The experimental arms (honey) were compared to the standard arm (supportive care).
Radiation esophagitis-related pain, 4 weeks from the start of treatment as measured by the Numerical Rating Pain Scale for pain on swallowing (NRPS)
Complete list of historical versions of study NCT01262560 on ClinicalTrials.gov Archive Site
  • Radiation Esophagitis-related Pain During Treatment as Measured During Treatment and 12 Weeks by the Numerical Rating Pain Scale (NRPS) [ Time Frame: Baseline, weekly during treatment, and 12 weeks from the start of treatment ]
    Esophagitis-related pain was measured using patient-reported pain on swallowing as assessed by the Numerical Rating Pain Scale (NRPS), an 11-point scale (0-10) in which 0 indicates no pain and 10 indicates the worst pain imaginable. Generally, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Change was calculated by subtracting the baseline value from values at the later time points. The experimental arms (honey) were compared to the standard arm (supportive care).
  • Dysphagia Via Daily Patient Log [ Time Frame: Weekly during treatment and 12 weeks from the start of treatment ]
    Dysphagia, as reported by the patient, was measured by the patient swallowing diary. Swallowing score has increasing severity 1-5, where 1 = "none" and 5 = "cannot swallow liquids".
  • 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 ]
    The pain symptom subscale (2 items) evaluated pain and the global score (30 items) evaluated quality of life. Each ranges from 0-100 with lower scores indicating lesser burden and improved symptoms or quality of life.
  • Percentage of Participants With Radiation Esophagitis Grade 3-4 (CTCAE v. 4) [ Time Frame: Up to 12 weeks from the start of treatment ]
    Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For esophagitis specifically, Grade 3 criteria includes severely altered eating/swallowing, tube feeding, total parenteral nutrition (TPN) or hospitalization indicated. Grade 4 criteria include life-threatening consequences, urgent operative intervention indicated.
  • Percent Change in Weight From Baseline to 4 Weeks [ Time Frame: Baseline and 4 weeks from the start of treatment ]
  • Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks) [ Time Frame: Baseline and 4 weeks from the start of treatment ]
  • Percentage of Patients Using Opioids [ Time Frame: Baseline, 4 weeks, end of radiation treatment, and 12 weeks from the start of treatment ]
    The percentage of patients using opioid analgesics is reported. Use of opioid analgesics was assessed for a 24-hour period before completing the assessment. Patients with at least one reported administration of opioid analgesic were considered to have received opioid analgesics.
  • Adverse Events Associated With Manuka Honey Using CTCAE v4.0 [ Time Frame: Until 12 weeks from the start of treatment ]
    Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
  • 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) [ Time Frame: Baseline and 4 weeks from the start of treatment ]
    Change from baseline to four weeks in patient-reported difficulty in swallowing via the PRO-CTCAE. PRO-CTCAE is an item bank consisting of individual items to assess adverse symptom events from the patient perspective. There are 78 symptoms included in the survey but the primary item of interest assesses difficulty swallowing. For each AE in the PRO-CTCAE, between 1 and 3 items are included to assess the frequency, severity, and/or interference with activities related to that AE. Frequency questions have responses ranging from never, which is scored as a 0, to almost constantly, which is scored as a 4. Severity questions have responses ranging from none, which is scored as a 0, to very severe, which is scored as a 4. Interference questions have responses ranging from not at all, which is scored as a 0, to very much, which is scored as a 4. Difficulty in swallowing only has a severity question.
  • Radiation esophagitis during treatment as measured weekly during treatment and 12 weeks from the start of treatment by the NRPS
  • Dysphagia Via Daily Patient Log
  • Quality of Life and Pain, as Measured by the EORTC QLQ-30 Global QOL Score and Pain Symptom Subscale at 4 and 12 Weeks
  • Radiation esophagitis grade 3-4 (CTCAE, v. 4)
  • Weight loss (percent change from baseline to 4 weeks)
  • Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks)
  • Opioid use
  • Adverse events associated with Manuka honey using CTCAE, v. 4
  • Patient reported adverse events associated with Manuka honey using the PRO-CTCAE
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 Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (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 QLQ-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: None (Open Label)
Primary Purpose: Supportive Care
  • Dysphagia
  • Lung Cancer
  • Pain
  • Esophagitis
  • Drug: Manuka honey in liquid form
    Patients swallow 10 cc (approximately 2 level teaspoons) of liquid Manuka honey 4 times per day while awake over an approximately 12 hour period (e.g. 8 a.m., Noon, 4 p.m., and 8 p.m.) 7 days/week during concurrent chemotherapy and radiation treatment.
  • Drug: Manuka honey in lozenge form
    Patients place 2 lozenges (the equivalent of 10 cc of liquid Manuka honey), one at a time, in the mouth, allowing each lozenge to dissolve on the tongue/in the mouth, swallowing the honey as it dissolves. Patients do this 4 times per day while awake over an approximately 12 hour period (e.g. 8 a.m., Noon, 4 p.m., and 8 p.m.) 7 days/week during concurrent chemotherapy and radiation treatment.
  • Drug: Standard supportive care

    Patients receive standard supporting care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment. The following regimen is recommended, but the local standard of care is permitted.

    1. A compound containing viscous lidocaine and magnesium aluminum oxide (Maalox®);
    2. Liquid or solid oxycodone, 5-10 mg, every 3 hours as needed.
  • Active Comparator: Supportive Care
    Standard supportive care
    Intervention: Drug: Standard supportive care
  • Experimental: Liquid Manuka Honey
    Manuka honey in liquid form
    Intervention: Drug: Manuka honey in liquid form
  • Experimental: Lozenge Manuka Honey
    Manuka honey in lozenge form
    Intervention: Drug: Manuka honey in lozenge form
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
November 2014
February 2014   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01262560
RTOG 1012
RTOG-1012
CDR0000690182
NCI-2011-02620 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Yes
Not Provided
Not Provided
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
August 2017

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