Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer
- Conditions
- DysphagiaLung CancerPainEsophagitis
- Interventions
- Drug: Standard supportive careDrug: Manuka honey in liquid formDrug: Manuka honey in lozenge form
- Registration Number
- NCT01262560
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supportive Care Standard supportive care Standard supportive care Liquid Manuka Honey Manuka honey in liquid form Manuka honey in liquid form Lozenge Manuka Honey Manuka honey in lozenge form Manuka honey in lozenge form
- Primary Outcome Measures
Name Time Method Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS) 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).
- Secondary Outcome Measures
Name Time Method Quality of Life and Pain, as Measured by the EORTC QLQ-30 Global QOL Score and Pain Symptom Subscale at 4 and 12 Weeks 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.
Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks) Baseline and 4 weeks from the start of treatment Percentage of Patients Using Opioids 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.
Radiation Esophagitis-related Pain During Treatment as Measured During Treatment and 12 Weeks by the Numerical Rating Pain Scale (NRPS) 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 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".
Percentage of Participants With Radiation Esophagitis Grade 3-4 (CTCAE v. 4) 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 Baseline and 4 weeks from the start of treatment Adverse Events Associated With Manuka Honey Using CTCAE v4.0 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) 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.
Trial Locations
- Locations (59)
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
York Cancer Center at Apple Hill Medical Center
🇺🇸York, Pennsylvania, United States
Parkview Regional Cancer Center at Parkview Health
🇺🇸Fort Wayne, Indiana, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
Providence Cancer Center at Providence Hospital
🇺🇸Mobile, Alabama, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Florida Cancer Center - Palatka
🇺🇸Palatka, Florida, United States
Piedmont Fayette Hospital
🇺🇸Fayetteville, Georgia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
🇺🇸Savannah, Georgia, United States
Queen's Cancer Institute at Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Hawaii Medical Center - East
🇺🇸Honolulu, Hawaii, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Cancer Center at Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
Regional Cancer Center at Singing River Hospital
🇺🇸Pascagoula, Mississippi, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
CentraCare Clinic - River Campus
🇺🇸Saint Cloud, Minnesota, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
Payson Center for Cancer Care at Concord Hospital
🇺🇸Concord, New Hampshire, United States
Seacoast Cancer Center at Wentworth - Douglass Hospital
🇺🇸Dover, New Hampshire, United States
Elliot Regional Cancer Center at Elliot Hospital
🇺🇸Manchester, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
🇺🇸Marlton, New Jersey, United States
Highland Hospital of Rochester
🇺🇸Rochester, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Rex Cancer Center at Rex Hospital
🇺🇸Raleigh, North Carolina, United States
Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Trinity CancerCare Center
🇺🇸Minot, North Dakota, United States
Cleveland Clinic Cancer Center
🇺🇸Independence, Ohio, United States
Mercy Cancer Center at Mercy Medical Center
🇺🇸Canton, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
🇺🇸Mayfield Heights, Ohio, United States
Parma Community General Hospital
🇺🇸Parma, Ohio, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health
🇺🇸Danville, Pennsylvania, United States
Northeast Radiation Oncology Center
🇺🇸Dunmore, Pennsylvania, United States
Adams Cancer Center
🇺🇸Gettysburg, Pennsylvania, United States
Cherry Tree Cancer Center
🇺🇸Hanover, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States