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

NCT01262560 | Completed Phase 2 Results DMC

• 4 other identifiers: RTOG 1012RTOG-1012CDR0000690182NCI-2011-02620
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 59

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.

Conditions

Dysphagia; Lung Cancer; Pain; Esophagitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS)

  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).

  Baseline and 4 weeks from the start of treatment

Secondary Outcomes (9)

• 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

• Dysphagia Via Daily Patient Log

  Weekly during treatment and 12 weeks from the start of treatment

• 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

• Percentage of Participants With Radiation Esophagitis Grade 3-4 (CTCAE v. 4)

  Up to 12 weeks from the start of treatment

• Percent Change in Weight From Baseline to 4 Weeks

  Baseline and 4 weeks from the start of treatment

Study Arms (3)

Supportive Care

ACTIVE COMPARATOR

Standard supportive care

Drug: Standard supportive care

Liquid Manuka Honey

EXPERIMENTAL

Manuka honey in liquid form

Drug: Manuka honey in liquid form

Lozenge Manuka Honey

EXPERIMENTAL

Manuka honey in lozenge form

Drug: Manuka honey in lozenge form

Interventions

Manuka honey in liquid form 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.

Liquid Manuka Honey

Manuka honey in lozenge form 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.

Lozenge Manuka Honey

Standard supportive care 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.

Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (59)

Providence Cancer Center at Providence Hospital

Mobile, Alabama, 36608, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Stanford Cancer Center

Stanford, California, 94305-5824, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Florida Cancer Center - Palatka

Palatka, Florida, 32177, United States

Location

Piedmont Fayette Hospital

Fayetteville, Georgia, 30214, United States

Location

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Hawaii Medical Center - East

Honolulu, Hawaii, 96817, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61615-7827, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Parkview Regional Cancer Center at Parkview Health

Fort Wayne, Indiana, 46805, United States

Location

Cancer Center at Ball Memorial Hospital

Muncie, Indiana, 47303-3499, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, 56303, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

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

St Louis, Missouri, 63141, United States

Location

Payson Center for Cancer Care at Concord Hospital

Concord, New Hampshire, 03301, United States

Location

Seacoast Cancer Center at Wentworth - Douglass Hospital

Dover, New Hampshire, 03820, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Elliot Regional Cancer Center at Elliot Hospital

Manchester, New Hampshire, 03103, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, 08053, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

Highland Hospital of Rochester

Rochester, New York, 14620, United States

Location

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

Rochester, New York, 14642, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

Rex Cancer Center at Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Trinity CancerCare Center

Minot, North Dakota, 58701, United States

Location

Mercy Cancer Center at Mercy Medical Center

Canton, Ohio, 44708, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

Parma Community General Hospital

Parma, Ohio, 44129, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, 17822-0001, United States

Location

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, 18512, United States

Location

Adams Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Cherry Tree Cancer Center

Hanover, Pennsylvania, 17331, United States

Location

Cancer Center of Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

York Cancer Center at Apple Hill Medical Center

York, Pennsylvania, 17405, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0361, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, 54303, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Lung Neoplasms; Pain; Esophagitis; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Carcinoma, Bronchogenic; Bronchial Neoplasms

Results Point of Contact

• Title: Wendy Seiferheld, M.S.
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

Study Officials

• Lawrence B. Berk, MD, PhD

  Tampa General Hospital, University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: February 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 31, 2017
• Results First Posted: August 31, 2017

Record last verified: 2017-08

Locations

US (59)