Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

275

Participants

Timeline

Start Date

November 18, 2014

Primary Completion Date

May 23, 2016

Study Completion Date

March 15, 2019

Conditions
Acute Oral Mucositis Pain
Interventions
DRUG

doxepin hydrochloride oral solution

2.5 mL (25 mg) doxepin and 2.5 mL water administered orally

DRUG

DLA (diphenhydramine, lidocaine and antacids) rinse

5.0 mL administered orally

OTHER

Placebo

2.5 mL placebo and 2.5 mL water administered orally

Trial Locations (350)

11040

North Shore-LIJ Health System/Center for Advanced Medicine, New Hyde Park

14215

Veterans Affairs Western New York Health Care System-Buffalo, Buffalo

14263

Roswell Park Cancer Institute, Buffalo

16801

Geisinger Medical Group, State College

17044

Lewistown Hospital, Lewistown

17325

Adams Cancer Center, Gettysburg

17405

WellSpan Health-York Hospital, York

17822

Geisinger Medical Center, Danville

17901

Geisinger Medical Oncology-Pottsville, Pottsville

18201

Geisinger Medical Center-Cancer Center Hazelton, Hazleton

18711

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre

20422

Veterans Affairs Medical Center - Washington, DC, Washington D.C.

22901

Martha Jefferson Hospital, Charlottesville

27030

Novant Health Oncology Specialists-Mount Airy, Mount Airy

27103

Novant Health Forsyth Medical Center, Winston-Salem

Novant Health Oncology Specialists, Winston-Salem

Winston-Salem Health Care, Winston-Salem

27203

Randolph Hospital, Asheboro

27284

Novant Health Oncology Specialists-Kernersville, Kernersville

27295

Novant Health Oncology Specialists-Davidson County, Lexington

27320

Annie Penn Memorial Hospital, Reidsville

27403

Cone Health Cancer Center, Greensboro

27534

Southeastern Medical Oncology Center-Goldsboro, Goldsboro

Wayne Memorial Hospital, Goldsboro

27893

Southeastern Medical Oncology Center-Wilson, Wilson

28054

CaroMont Regional Medical Center, Gastonia

28078

Lake Norman Hematology Oncology Specialists-Huntersville, Huntersville

Southern Oncology Specialists-Huntersville, Huntersville

28105

Matthews Radiation Oncology Center, Matthews

Novant Health Cancer Specialists-Matthews, Matthews

28117

Lake Norman Hematology Oncology Specialists-Mooresville, Mooresville

28144

Carolina Oncology Associates PA, Salisbury

28204

Novant Health Presbyterian Medical Center, Charlotte

28207

Carolina Surgical Clinic of Charlotte PA, Charlotte

Oncology Specialists of Charlotte, Charlotte

28262

Southern Oncology Specialists-Charlotte, Charlotte

28328

Southeastern Medical Oncology Center-Clinton, Clinton

28374

FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst

28546

Southeastern Medical Oncology Center-Jacksonville, Jacksonville

28625

Novant Health Oncology Specialists-Statesville, Statesville

28659

Novant Health Oncology Specialists-Wilkesboro, Wilkesboro

28739

Hendersonville Hematology and Oncology at Pardee, Hendersonville

28791

Margaret R Pardee Memorial Hospital, Hendersonville

29303

Spartanburg Medical Center, Spartanburg

29307

Greenville Health System Cancer Institute-Spartanburg, Spartanburg

29341

Gibbs Cancer Center-Gaffney, Gaffney

29605

Greenville Health System Cancer Institute - Butternut, Greenville

Greenville Health System Cancer Institute-Andrews, Greenville

Greenville Health System Cancer Institute-Faris, Greenville

Greenville Memorial Hospital, Greenville

29615

Greenville Health System Cancer Institute-Eastside, Greenville

29621

AnMed Health Cancer Center, Anderson

29640

Greenville Health System Cancer Institute-Easley, Easley

29650

Greenville Health System Cancer Institute-Greer, Greer

29651

Gibbs Cancer Center-Pelham, Greer

29672

Greenville Health System Cancer Institute-Seneca, Seneca

29902

Beaufort Memorial Hospital, Beaufort

33021

Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood

33028

Memorial Hospital West, Pembroke Pines

33140

Mount Sinai Medical Center, Miami Beach

33607

Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa

33756

Morton Plant Hospital, Clearwater

46544

Memorial Regional Cancer Center Day Road, Mishawaka

46601

Memorial Hospital of South Bend, South Bend

48060

Saint Joseph Mercy Port Huron, Port Huron

48073

William Beaumont Hospital - Royal Oak, Royal Oak

48093

Saint John Macomb-Oakland Hospital, Warren

48098

William Beaumont Hospital - Troy, Troy

48106

Saint Joseph Mercy Hospital, Ann Arbor

48124

Oakwood Hospital and Medical Center, Dearborn

48154

Saint Mary Mercy Hospital, Livonia

48236

Saint John Hospital and Medical Center, Detroit

48341

Saint Joseph Mercy Oakland, Pontiac

48503

Genesys Hurley Cancer Institute, Flint

Hurley Medical Center, Flint

48601

Saint Mary's of Michigan, Saginaw

48912

Sparrow Hospital, Lansing

49001

Borgess Medical Center, Kalamazoo

49007

Bronson Methodist Hospital, Kalamazoo

49017

Bronson Battle Creek, Battle Creek

49085

Lakeland Hospital, Saint Joseph

Marie Yeager Cancer Center, Saint Joseph

49120

Lakeland Community Hospital, Niles

49201

Allegiance Health, Jackson

49431

Green Bay Oncology - Escanaba, Escanaba

49444

Mercy Health Mercy Campus, Muskegon

49503

Mercy Health Saint Mary's, Grand Rapids

Spectrum Health at Butterworth Campus, Grand Rapids

49677

Spectrum Health Reed City Hospital, Reed City

49684

Munson Medical Center, Traverse City

49801

Green Bay Oncology - Iron Mountain, Iron Mountain

50266

Methodist West Hospital, West Des Moines

50309

Iowa Methodist Medical Center, Des Moines

Medical Oncology and Hematology Associates - Des Moines, Des Moines

50316

Iowa Lutheran Hospital, Des Moines

51101

Siouxland Regional Cancer Center, Sioux City

52403

Mercy Hospital, Cedar Rapids

Oncology Associates at Mercy Medical Center, Cedar Rapids

52722

Constantinou, Costas L MD (UIA Investigator), Bettendorf

53081

Saint Nicholas Hospital, Sheboygan

54017

Westfields Hospital/Cancer Center of Western Wisconsin, New Richmond

54143

Bay Area Medical Center, Marinette

54154

Green Bay Oncology - Oconto Falls, Oconto Falls

54221

Holy Family Memorial Hospital, Manitowoc

54235

Green Bay Oncology - Sturgeon Bay, Sturgeon Bay

54301

Green Bay Oncology at Saint Vincent Hospital, Green Bay

Saint Vincent Hospital, Green Bay

54303

Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay

Saint Mary's Hospital, Green Bay

54401

Marshfield Clinic-Wausau Center, Wausau

54449

Marshfield Clinic, Marshfield

Saint Joseph's Hospital, Marshfield

54476

Diagnostic and Treatment Center, Weston

Marshfield Clinic - Weston Center, Weston

Saint Clare's Hospital, Weston

54481

Marshfield Clinic at Saint Michael's Hospital, Stevens Point

Saint Michael's Hospital, Stevens Point

54494

Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids

54501

Marshfield Clinic at James Beck Cancer Center, Rhinelander

54548

Marshfield Clinic-Minocqua Center, Minocqua

54601

Mayo Clinic Health System-Franciscan Healthcare, La Crosse

54701

Marshfield Clinic Cancer Center at Sacred Heart, Eau Claire

Sacred Heart Hospital, Eau Claire

54729

Marshfield Clinic-Chippewa Center, Chippewa Falls

54868

Marshfield Clinic-Rice Lake Center, Rice Lake

54935

Saint Agnes Hospital/Agnesian Cancer Center, Fond du Lac

55082

Lakeview Hospital, Stillwater

55101

Regions Hospital, Saint Paul

55102

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology PA-Maplewood, Maplewood

Saint John's Hospital - Healtheast, Maplewood

55125

Minnesota Oncology Hematology PA-Woodbury, Woodbury

55337

Fairview Ridges Hospital, Burnsville

55350

Hutchinson Area Health Care, Hutchinson

55379

Saint Francis Regional Medical Center, Shakopee

55387

Ridgeview Medical Center, Waconia

55407

Abbott-Northwestern Hospital, Minneapolis

55415

Hennepin County Medical Center, Minneapolis

55416

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55422

North Memorial Medical Health Center, Robbinsdale

55432

Unity Hospital, Fridley

55433

Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

55454

Health Partners Inc, Minneapolis

55905

Mayo Clinic, Rochester

56073

New Ulm Medical Center, New Ulm

56201

Rice Memorial Hospital, Willmar

56601

Sanford Clinic North-Bemidji, Bemidji

57104

Sanford Cancer Center Oncology Clinic, Sioux Falls

57105

Avera Cancer Institute, Sioux Falls

57117

Sanford USD Medical Center - Sioux Falls, Sioux Falls

57401

Avera Saint Luke's Hospital and Cancer Center, Aberdeen

58102

Sanford Clinic North-Fargo, Fargo

58122

Sanford Medical Center-Fargo, Fargo

Sanford Roger Maris Cancer Center, Fargo

58201

Altru Cancer Center, Grand Forks

58501

Sanford Bismarck Medical Center, Bismarck

61108

OSF Saint Anthony Medical Center, Rockford

61265

Garneau, Stewart C MD (UIA Investigator), Moline

Spector, David MD (UIA Investigator), Moline

Trinity Medical Center, Moline

61350

Illinois CancerCare- Ottawa Clinic, Ottawa

Radiation Oncology of Northern Illinois, Ottawa

61354

Illinois CancerCare-Peru, Peru

Valley Radiation Oncology, Peru

61356

Illinois CancerCare-Princeton, Princeton

61401

Illinois CancerCare - Galesburg, Galesburg

Western Illinois Cancer Treatment Center, Galesburg

61443

Illinois CancerCare - Kewanee Clinic, Kewanee

61455

Illinois CancerCare - Macomb, Macomb

61520

Illinois CancerCare - Canton, Canton

61530

Illinois CancerCare - Eureka, Eureka

61554

Illinois CancerCare-Pekin, Pekin

Pekin Cancer Treatment Center, Pekin

61603

Methodist Medical Center of Illinois, Peoria

61615

Illinois CancerCare-Peoria, Peoria

61637

OSF St. Francis Medical Center, Peoria

61701

Illinois CancerCare - Bloomington, Bloomington

Saint Joseph Medical Center, Bloomington

62226

Cancer Care Specialists of Illinois-Swansea, Swansea

62401

Crossroads Cancer Center, Effingham

62526

Cancer Care Specialists of Central Illinois, Decatur

Decatur Memorial Hospital, Decatur

Heartland Cancer Research NCORP, Decatur

62702

Central Illinois Hematology Oncology Center, Springfield

62703

Springfield Clinic, Springfield

62801

Centralia Oncology Clinic, Centralia

62902

Memorial Hospital of Carbondale, Carbondale

63080

Missouri Baptist Sullivan Hospital, Sullivan

63109

Saint Louis Cancer and Breast Institute - South City, St Louis

63110

Washington University School of Medicine, St Louis

63127

Missouri Baptist Outpatient Center-Sunset Hills, Sunset Hills

63129

Siteman Cancer Center-South County, St Louis

63131

Missouri Baptist Medical Center, St Louis

63141

Barnes-Jewish West County Hospital, St Louis

Mercy Hospital Saint Louis, St Louis

63628

Parkland Health Center-Bonne Terre, Bonne Terre

63670

Sainte Genevieve County Memorial Hospital, Sainte Genevieve

63703

Saint Francis Medical Center, Cape Girardeau

Southeast Cancer Center, Cape Girardeau

65109

Capital Region Medical Center-Goldschmidt Cancer Center, Jefferson City

65401

Mercy Clinic-Rolla-Cancer and Hematology, Rolla

Phelps County Regional Medical Center, Rolla

65613

Central Care Center - Carrie J. Babb Cancer Center, Bolivar

65616

Cox Cancer Center Branson, Branson

65804

Cancer Research for the Ozarks NCORP, Springfield

Mercy Hospital Springfield, Springfield

65807

Cox Health South Hospital, Springfield

66044

Lawrence Memorial Hospital, Lawrence

66701

Cancer Center of Kansas - Fort Scott, Fort Scott

66720

Cancer Center of Kansas - Chanute, Chanute

67042

Cancer Center of Kansas - El Dorado, El Dorado

67068

Cancer Center of Kansas - Kingman, Kingman

67114

Cancer Center of Kansas - Newton, Newton

67124

Cancer Center of Kansas - Pratt, Pratt

67152

Cancer Center of Kansas - Wellington, Wellington

67156

Cancer Center of Kansas - Winfield, Winfield

67208

Associates In Womens Health, Wichita

Cancer Center of Kansas - Wichita Medical Arts Tower, Wichita

67214

Cancer Center of Kansas - Main Office, Wichita

Via Christi Regional Medical Center, Wichita

Wesley Medical Center, Wichita

67301

Cancer Center of Kansas - Independence, Independence

67357

Cancer Center of Kansas - Parsons, Parsons

67401

Cancer Center of Kansas - Salina, Salina

67801

Cancer Center of Kansas - Dodge City, Dodge City

67901

Cancer Center of Kansas - Liberal, Liberal

73120

Mercy Hospital Oklahoma City, Oklahoma City

80012

Rocky Mountain Cancer Centers-Aurora, Aurora

The Medical Center of Aurora, Aurora

80033

Exempla Lutheran Medical Center, Wheat Ridge

80110

Swedish Medical Center, Englewood

80111

Rocky Mountain Cancer Centers-Greenwood Village, Greenwood Village

80113

Comprehensive Cancer Care and Research Institute of Colorado LLC, Englewood

80120

Rocky Mountain Cancer Centers-Littleton, Littleton

80122

Littleton Adventist Hospital, Littleton

80124

Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree

Sky Ridge Medical Center, Lone Tree

80138

Parker Adventist Hospital, Parker

Rocky Mountain Cancer Centers-Parker, Parker

80210

Porter Adventist Hospital, Denver

80218

Exempla Saint Joseph Hospital, Denver

Presbyterian - Saint Lukes Medical Center - Health One, Denver

Rocky Mountain Cancer Centers-Midtown, Denver

80220

Rocky Mountain Cancer Centers-Rose, Denver

Rose Medical Center, Denver

80228

Rocky Mountain Cancer Centers-Lakewood, Lakewood

Saint Anthony Hospital, Lakewood

80260

Rocky Mountain Cancer Centers-Thornton, Thornton

80301

Boulder Community Hospital, Boulder

80304

Rocky Mountain Cancer Centers-Boulder, Boulder

80401

Mountain Blue Cancer Care Center, Golden

80501

Longmont United Hospital, Longmont

Rocky Mountain Cancer Centers-Longmont, Longmont

80539

McKee Medical Center, Loveland

80631

North Colorado Medical Center, Greeley

80907

Penrose-Saint Francis Healthcare, Colorado Springs

Rocky Mountain Cancer Centers-Penrose, Colorado Springs

Colorado Blood Cancer Institute, Denver

81004

Saint Mary Corwin Medical Center, Pueblo

81008

Rocky Mountain Cancer Centers - Pueblo, Pueblo

81301

Mercy Medical Center, Durango

Southwest Oncology PC, Durango

82001

Cheyenne Regional Medical Center-West, Cheyenne

83301

Saint Luke's Mountain States Tumor Institute-Twin Falls, Twin Falls

83619

Saint Luke's Mountain States Tumor Institute - Fruitland, Fruitland

83642

Saint Luke's Mountain States Tumor Institute - Meridian, Meridian

83686

Saint Luke's Mountain States Tumor Institute - Nampa, Nampa

83706

Saint Alphonsus Cancer Care Center-Boise, Boise

83712

Saint Luke's Mountain States Tumor Institute, Boise

89052

Comprehensive Cancer Centers of Nevada - Henderson, Henderson

Las Vegas Cancer Center-Henderson, Henderson

89074

21st Century Oncology-Henderson, Henderson

Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson

89102

University Medical Center of Southern Nevada, Las Vegas

89106

Cancer and Blood Specialists-Henderson, Las Vegas

Nevada Cancer Research Foundation NCORP, Las Vegas

Radiation Oncology Centers of Nevada Central, Las Vegas

89109

21st Century Oncology, Las Vegas

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway, Las Vegas

89113

HealthCare Partners Medical Group Oncology/Hematology-San Martin, Las Vegas

89119

Radiation Oncology Centers of Nevada Southeast, Las Vegas

89121

Cancer Therapy and Integrative Medicine, Las Vegas

89128

21st Century Oncology-Vegas Tenaya, Las Vegas

Cancer and Blood Specialists-Shadow, Las Vegas

Cancer and Blood Specialists-Tenaya, Las Vegas

Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas

HealthCare Partners Medical Group Oncology/Hematology-Tenaya, Las Vegas

89144

Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas

89148

21st Century Oncology-Fort Apache, Las Vegas

Cancer and Blood Specialists-Fort Apache, Las Vegas

89149

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills, Las Vegas

89169

Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas

Comprehensive Cancer Centers of Nevada, Las Vegas

91505

Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank

94568

Epic Care-Dublin, Dublin

94608

Bay Area Breast Surgeons Inc, Emeryville

Epic Care Partners in Cancer Care, Emeryville

94609

Alta Bates Summit Medical Center - Summit Campus, Oakland

Bay Area Tumor Institute CCOP, Oakland

Hematology and Oncology Associates-Oakland, Oakland

97015

Clackamas Radiation Oncology Center, Clackamas

Providence Oncology and Hematology Care Southeast, Clackamas

97045

Providence Willamette Falls Medical Center, Oregon City

97132

Providence Newberg Medical Center, Newberg

97213

Providence Portland Medical Center, Portland

97225

Providence Saint Vincent Medical Center, Portland

97420

Bay Area Hospital, Coos Bay

97701

Saint Charles Health System, Bend

98005

Swedish Cancer Institute-Eastside Oncology Hematology, Bellevue

98026

Swedish Medical Center-Edmonds, Edmonds

98029

Swedish Medical Center - Issaquah, Issaquah

98104

Minor and James Medical PLLC, Seattle

Pacific Gynecology Specialists, Seattle

98107

Swedish Medical Center-Ballard Campus, Seattle

98112

Group Health Cooperative-Seattle, Seattle

98122

Swedish Medical Center-First Hill, Seattle

98201

Providence Regional Cancer Partnership, Everett

98221

Cancer Care Center at Island Hospital, Anacortes

98225

PeaceHealth Saint Joseph Medical Center, Bellingham

98503

Providence Regional Cancer System-Lacey, Lacey

98520

Providence Regional Cancer System-Aberdeen, Aberdeen

98531

Providence Regional Cancer System-Centralia, Centralia

98548

Providence Regional Cancer System-Shelton, Shelton

98597

Providence Regional Cancer System-Yelm, Yelm

98632

Saint John Medical Center, Longview

98664

PeaceHealth Southwest Medical Center, Vancouver

98902

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima

99204

Rockwood Cancer Treatment Center-DHEC-Downtown, Spokane

99216

Rockwood Clinic Cancer Treatment Center-Valley, Spokane Valley

99218

Evergreen Hematology and Oncology PS, Spokane

99362

Providence Saint Mary Regional Cancer Center, Walla Walla

99504

Anchorage Radiation Therapy Center, Anchorage

99508

Alaska Breast Care and Surgery LLC, Anchorage

Alaska Oncology and Hematology LLC, Anchorage

Alaska Regional Hospital, Anchorage

Alaska Women's Cancer Care, Anchorage

Anchorage Oncology Centre, Anchorage

Katmai Oncology Group, Anchorage

Providence Alaska Medical Center, Anchorage

287078

Lake Norman Hematology Oncology Specialists-Huntersville, Huntersville

94553-3156

Contra Costa Regional Medical Center, Martinez

06105

Saint Francis Hospital and Medical Center, Hartford

06457

Middlesex Hospital, Middletown

61615-7827

OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC, Peoria

62781-0001

Memorial Medical Center, Springfield

04102

Maine Medical Center - Bramhall Campus, Portland

49007-3731

West Michigan Cancer Center, Kalamazoo

89148-2405

Las Vegas Cancer Center-Medical Center, Las Vegas

54235-1495

Door County Cancer Center, Sturgeon Bay

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Alliance for Clinical Trials in Oncology

OTHER

NCT02229539 - Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy | Biotech Hunter | Biotech Hunter