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

PHASE2CompletedINTERVENTIONAL
Enrollment

163

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

February 28, 2014

Study Completion Date

November 30, 2014

Conditions
DysphagiaLung CancerPainEsophagitis
Interventions
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."

Trial Locations (59)

13057

CCOP - Hematology-Oncology Associates of Central New York, East Syracuse

14620

Highland Hospital of Rochester, Rochester

14642

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

17325

Adams Cancer Center, Gettysburg

17331

Cherry Tree Cancer Center, Hanover

17405

York Cancer Center at Apple Hill Medical Center, York

18512

Northeast Radiation Oncology Center, Dunmore

19001

Rosenfeld Cancer Center at Abington Memorial Hospital, Abington

19010

Bryn Mawr Hospital, Bryn Mawr

19096

Lankenau Cancer Center at Lankenau Hospital, Wynnewood

19713

CCOP - Christiana Care Health Services, Newark

27607

Rex Cancer Center at Rex Hospital, Raleigh

27710

Duke Cancer Institute, Durham

28374

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center, Pinehurst

28791

Pardee Memorial Hospital, Hendersonville

29303

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg

30214

Piedmont Fayette Hospital, Fayetteville

31405

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

32177

Florida Cancer Center - Palatka, Palatka

32207

Baptist Cancer Institute - Jacksonville, Jacksonville

33140

CCOP - Mount Sinai Medical Center, Miami Beach

36608

Providence Cancer Center at Providence Hospital, Mobile

39581

Regional Cancer Center at Singing River Hospital, Pascagoula

44111

Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland

44124

Hillcrest Cancer Center at Hillcrest Hospital, Mayfield Heights

44129

Parma Community General Hospital, Parma

44131

Cleveland Clinic Cancer Center, Independence

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

44708

Mercy Cancer Center at Mercy Medical Center, Canton

46805

Parkview Regional Cancer Center at Parkview Health, Fort Wayne

54303

St. Mary's Hospital Medical Center - Green Bay, Green Bay

56303

CentraCare Clinic - River Campus, Saint Cloud

58701

Trinity CancerCare Center, Minot

61801

CCOP - Carle Cancer Center, Urbana

63110

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St Louis

63141

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

94115

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

96813

Queen's Cancer Institute at Queen's Medical Center, Honolulu

96817

Hawaii Medical Center - East, Honolulu

98225

St. Joseph Cancer Center, Bellingham

94305-5824

Stanford Cancer Center, Stanford

61615-7827

OSF St. Francis Medical Center, Peoria

47303-3499

Cancer Center at Ball Memorial Hospital, Muncie

40536-0093

Lucille P. Markey Cancer Center at University of Kentucky, Lexington

02601

Cape Cod Hospital, Hyannis

03301

Payson Center for Cancer Care at Concord Hospital, Concord

03820

Seacoast Cancer Center at Wentworth - Douglass Hospital, Dover

03756-0002

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon

03103

Elliot Regional Cancer Center at Elliot Hospital, Manchester

07740-6395

Monmouth Medical Center, Long Branch

08053

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton

28233-3549

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte

27157-1096

Wake Forest University Comprehensive Cancer Center, Winston-Salem

44106-5065

Case Comprehensive Cancer Center, Cleveland

17822-0001

Geisinger Cancer Institute at Geisinger Health, Danville

19301-1792

Cancer Center of Paoli Memorial Hospital, Paoli

77555-0361

University of Texas Medical Branch, Galveston

78229-3900

University of Texas Health Science Center at San Antonio, San Antonio

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK