High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

June 5, 2025

Primary Completion Date

August 15, 2029

Study Completion Date

April 15, 2031

Conditions
Head and Neck Squamous Cell CarcinomaStage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Interventions
DRUG

Gabapentin

Given PO

DRUG

Placebo

Given PO

DRUG

Chemotheraphy

Receive standard of care chemotherapy

RADIATION

Radiation Therapy

Undergo standard of care radiation

DRUG

Analgesic Agent

Receive standard of care pain medication

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Survey Administration

Ancillary studies

Trial Locations (95)

10461

RECRUITING

Montefiore Medical Center-Einstein Campus, The Bronx

10467

RECRUITING

Montefiore Medical Center - Moses Campus, The Bronx

14263

RECRUITING

Roswell Park Cancer Institute, Buffalo

15025

RECRUITING

Jefferson Hospital, Jefferson Hills

15090

RECRUITING

Wexford Health and Wellness Pavilion, Wexford

15146

RECRUITING

Forbes Hospital, Monroeville

RECRUITING

UPMC Cancer Center - Monroeville, Monroeville

RECRUITING

UPMC Hillman Cancer Center - Monroeville, Monroeville

15212

RECRUITING

Allegheny General Hospital, Pittsburgh

15232

RECRUITING

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

RECRUITING

UPMC-Shadyside Hospital, Pittsburgh

15243

RECRUITING

UPMC-Saint Clair Hospital Cancer Center, Pittsburgh

15601

RECRUITING

UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg

16121

RECRUITING

UPMC Cancer Center at UPMC Horizon, Farrell

16346

RECRUITING

UPMC Cancer Center at UPMC Northwest, Seneca

16505

RECRUITING

UPMC Hillman Cancer Center Erie, Erie

16544

RECRUITING

Saint Vincent Hospital, Erie

17050

RECRUITING

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion, Mechanicsburg

17109

RECRUITING

UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg

17822

RECRUITING

Geisinger Medical Center, Danville

17837

RECRUITING

Geisinger Medical Oncology-Lewisburg, Lewisburg

17901

RECRUITING

Geisinger Cancer Services-Pottsville, Pottsville

18519

RECRUITING

Geisinger Cancer Center Dickson City, Dickson City

18711

RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre

44710

RECRUITING

Aultman Health Foundation, Canton

50010

RECRUITING

Mary Greeley Medical Center, Ames

RECRUITING

McFarland Clinic - Ames, Ames

50036

RECRUITING

McFarland Clinic - Boone, Boone

50129

RECRUITING

McFarland Clinic - Jefferson, Jefferson

50158

RECRUITING

McFarland Clinic - Marshalltown, Marshalltown

50501

RECRUITING

McFarland Clinic - Trinity Cancer Center, Fort Dodge

51503

RECRUITING

Methodist Jennie Edmundson Hospital, Council Bluffs

52402

RECRUITING

Saint Luke's Hospital, Cedar Rapids

52403

RECRUITING

Mercy Hospital, Cedar Rapids

RECRUITING

Oncology Associates at Mercy Medical Center, Cedar Rapids

54401

RECRUITING

Aspirus Regional Cancer Center, Wausau

54409

RECRUITING

Langlade Hospital and Cancer Center, Antigo

54451

RECRUITING

Aspirus Medford Hospital, Medford

54481

RECRUITING

Aspirus Cancer Care - Stevens Point, Stevens Point

54494

RECRUITING

Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids

54501

RECRUITING

Aspirus Cancer Care - James Beck Cancer Center, Rhinelander

56601

RECRUITING

Sanford Joe Lueken Cancer Center, Bemidji

57104

RECRUITING

Sanford Cancer Center Oncology Clinic, Sioux Falls

58122

RECRUITING

Sanford Broadway Medical Center, Fargo

RECRUITING

Sanford Roger Maris Cancer Center, Fargo

58501

RECRUITING

Sanford Bismarck Medical Center, Bismarck

59101

RECRUITING

Billings Clinic Cancer Center, Billings

59405

RECRUITING

Benefis Sletten Cancer Institute, Great Falls

59711

RECRUITING

Community Hospital of Anaconda, Anaconda

59804

RECRUITING

Community Medical Center, Missoula

59901

RECRUITING

Logan Health Medical Center, Kalispell

60504

RECRUITING

Rush-Copley Medical Center, Aurora

61021

RECRUITING

Illinois CancerCare-Dixon, Dixon

61265

RECRUITING

Trinity Medical Center, Moline

61350

RECRUITING

Illinois CancerCare-Ottawa Clinic, Ottawa

61354

RECRUITING

Illinois CancerCare-Peru, Peru

61356

RECRUITING

Illinois CancerCare-Princeton, Princeton

61401

RECRUITING

Illinois CancerCare-Galesburg, Galesburg

61443

RECRUITING

Illinois CancerCare-Kewanee Clinic, Kewanee

61455

RECRUITING

Illinois CancerCare-Macomb, Macomb

61520

RECRUITING

Illinois CancerCare-Canton, Canton

61530

RECRUITING

Illinois CancerCare-Eureka, Eureka

61554

RECRUITING

Illinois CancerCare-Pekin, Pekin

61571

RECRUITING

Illinois CancerCare - Washington, Washington

61615

RECRUITING

Illinois CancerCare-Peoria, Peoria

61704

RECRUITING

Illinois CancerCare-Bloomington, Bloomington

61761

RECRUITING

Carle BroMenn Medical Center, Normal

RECRUITING

Carle Cancer Institute Normal, Normal

61801

RECRUITING

Carle Cancer Center, Urbana

61832

RECRUITING

Carle at The Riverfront, Danville

61938

RECRUITING

Carle Physician Group-Mattoon/Charleston, Mattoon

62321

RECRUITING

Illinois CancerCare-Carthage, Carthage

62401

RECRUITING

Carle Physician Group-Effingham, Effingham

RECRUITING

Crossroads Cancer Center, Effingham

62526

RECRUITING

Cancer Care Specialists of Illinois - Decatur, Decatur

RECRUITING

Decatur Memorial Hospital, Decatur

62702

RECRUITING

Southern Illinois University School of Medicine, Springfield

RECRUITING

Springfield Clinic, Springfield

62781

RECRUITING

Springfield Memorial Hospital, Springfield

63128

RECRUITING

Mercy Hospital South, St Louis

63703

RECRUITING

Saint Francis Medical Center, Cape Girardeau

64804

RECRUITING

Freeman Health System, Joplin

68114

RECRUITING

Nebraska Methodist Hospital, Omaha

68118

RECRUITING

Nebraska Medicine-Village Pointe, Omaha

68123

RECRUITING

Nebraska Medicine-Bellevue, Bellevue

68198

RECRUITING

University of Nebraska Medical Center, Omaha

68847

SUSPENDED

CHI Health Good Samaritan, Kearney

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

83814

RECRUITING

Kootenai Health - Coeur d'Alene, Coeur d'Alene

83854

RECRUITING

Kootenai Clinic Cancer Services - Post Falls, Post Falls

83864

RECRUITING

Kootenai Clinic Cancer Services - Sandpoint, Sandpoint

90033

RECRUITING

Los Angeles General Medical Center, Los Angeles

RECRUITING

USC / Norris Comprehensive Cancer Center, Los Angeles

93301

RECRUITING

AIS Cancer Center at San Joaquin Community Hospital, Bakersfield

57117-5134

RECRUITING

Sanford USD Medical Center - Sioux Falls, Sioux Falls

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Alliance for Clinical Trials in Oncology

OTHER