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

NCT ID: NCT01262560

Last Updated: 2017-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-11-30

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.

Conditions

Dysphagia; Lung Cancer; Pain; Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive Care

Standard supportive care

Group Type: ACTIVE_COMPARATOR

Standard supportive care

Intervention Type: DRUG

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.

Liquid Manuka Honey

Manuka honey in liquid form

Group Type: EXPERIMENTAL

Manuka honey in liquid form

Intervention Type: DRUG

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.

Lozenge Manuka Honey

Manuka honey in lozenge form

Group Type: EXPERIMENTAL

Manuka honey in lozenge form

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

NRG Oncology

OTHER

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence B. Berk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampa General Hospital, University of South Florida

Locations

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

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Florida Cancer Center - Palatka

Palatka, Florida, United States

Piedmont Fayette Hospital

Fayetteville, Georgia, 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

Hawaii Medical Center - East

Honolulu, Hawaii, United States

OSF St. Francis Medical Center

Peoria, Illinois, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Parkview Regional Cancer Center at Parkview Health

Fort Wayne, Indiana, United States

Cancer Center at Ball Memorial Hospital

Muncie, Indiana, United States

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, United States

Cape Cod Hospital

Hyannis, Massachusetts, United States

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, United States

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 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

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Elliot Regional Cancer Center at Elliot Hospital

Manchester, New Hampshire, 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

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, United States

Highland Hospital of Rochester

Rochester, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, United States

Duke Cancer Institute

Durham, North Carolina, United States

Pardee Memorial Hospital

Hendersonville, North Carolina, United States

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

Pinehurst, North Carolina, United States

Rex Cancer Center at Rex Hospital

Raleigh, North Carolina, United States

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Trinity CancerCare Center

Minot, North Dakota, United States

Mercy Cancer Center at Mercy Medical Center

Canton, Ohio, 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

Cleveland Clinic Cancer Center

Independence, Ohio, United States

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, United States

Parma Community General Hospital

Parma, Ohio, United States

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, United States

Bryn Mawr Hospital

Bryn Mawr, 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

York Cancer Center at Apple Hill Medical Center

York, Pennsylvania, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

University of Texas Medical Branch

Galveston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

St. Joseph Cancer Center

Bellingham, Washington, United States

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, United States

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Countries

United States

Other Identifiers

RTOG-1012

Identifier Type: -

Identifier Source: secondary_id

CDR0000690182

Identifier Type: -

Identifier Source: secondary_id

NCI-2011-02620

Identifier Type: REGISTRY

Identifier Source: secondary_id

RTOG 1012

Identifier Type: -

Identifier Source: org_study_id