High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Purpose
This phase III trial tests if gabapentin can prevent the need for opiate pain medication for mouth sores (oral mucositis) in patients undergoing treatment with chemotherapy and radiation for squamous cell carcinoma of the head and neck region. Oral mucositis is a common side effect of radiation treatment and can cause severe pain, dysphagia, and weight loss resulting in feeding tube placement, worse health-related quality of life, treatment interruptions, unplanned hospitalizations, and significant financial burden. Mucositis pain is often treated with opioid pain medications which do provide pain relief but have many known side effects not limited to mental clouding, constipation, fatigue, endocrinopathy, neurotoxicity, sleep-disordered breathing, and most distressingly persistent opioid use. Gabapentin may help relieve pain from oral mucositis caused by radiation while also reducing the need for opiate pain medications for patients receiving chemotherapy and radiation for squamous cell carcinoma of the head and neck region
Conditions
- Head and Neck Squamous Cell Carcinoma
- Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologic documentation of disease: Squamous cell carcinoma of the head and neck region. * Stage: I-IV - No prior treatment for head and neck cancer - Planned treatment with cisplatin-based chemoradiation therapy (weekly or once every 3 weeks [q 3 week]) - Able to swallow capsules whole - No known hypersensitivity to gabapentin or its ingredients - No patients on dialysis or with transplanted organs - No prior surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer. Patients with a history of surgery and radioactive iodine for the treatment of thyroid cancer are eligible. Concurrent cancer therapy for other cancers is not allowed - No planned surgery or chemotherapy or immunotherapy following 7 weeks of standard chemoradiation treatment - No known brain metastases - No nonprescribed use of any opioids (including heroin) within 6 months prior to registration - No prescribed medications for chronic and/or long-term pain and/or neuropathy, including patients under treatment of a pain specialist or substance abuse programs. Acute post-biopsy medications are allowed if the patient has discontinued them 3 days prior to study registration - No current treatment with mefloquine - Age ≥ 18 years - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 - Creatinine ≤ 1.5 x upper limit of normal (ULN) - Not pregnant and not nursing, because this study involves both radiation and chemotherapy. In addition, the genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential, a negative pregnancy test done < 7 days prior to registration is required. Women must agree to using contraception for the duration of receiving study drugs and for 6 months after completing chemoradiation - Not taking medications for a psychotic psychiatric illness - No existing diagnosis of sleep apnea - No acute narrow-angle glaucoma - No uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - No investigational agent within 30 days prior to registration - No enrollment on other studies of systemic pain control agents - Language: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish - Patients with impaired decision making are not eligible for study
Exclusion Criteria
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Arm I (Placebo) |
Starting by radiation treatment 8, patients receive placebo PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with placebo continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive placebo TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study. |
|
|
Experimental Arm II (Gabapentin) |
Starting by radiation treatment 8, patients receive gabapentin PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with gabapentin continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive gabapentin TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study. |
|
Recruiting Locations
Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona 85297
Gilbert, Arizona 85297
Arizona Center for Cancer Care-Peoria
Peoria, Arizona 85381
Peoria, Arizona 85381
Contact:
Site Public Contact
623-773-2873
Site Public Contact
623-773-2873
Arizona Center for Cancer Care - Biltmore
Phoenix, Arizona 85016
Phoenix, Arizona 85016
Arizona Center for Cancer Care - Phoenix
Phoenix, Arizona 85027
Phoenix, Arizona 85027
Arizona Center for Cancer Care - Osborn
Scottsdale, Arizona 85251
Scottsdale, Arizona 85251
Arizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Arizona Center for Cancer Care-Surprise
Surprise, Arizona 85374
Surprise, Arizona 85374
Arizona Center for Cancer Care
Tempe, Arizona 85284
Tempe, Arizona 85284
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California 93301
Bakersfield, California 93301
Contact:
Site Public Contact
661-323-4673
Site Public Contact
661-323-4673
Kaiser Permanente Dublin
Dublin, California 94568
Dublin, California 94568
Contact:
Site Public Contact
877-642-4691
Site Public Contact
877-642-4691
Kaiser Permanente-Fremont
Fremont, California 94538
Fremont, California 94538
Kaiser Permanente Fresno Orchard Plaza
Fresno, California 93720
Fresno, California 93720
Contact:
Site Public Contact
833-574-2273
Site Public Contact
833-574-2273
Kaiser Permanente- Modesto MOB II
Modesto, California 95356
Modesto, California 95356
Contact:
Site Public Contact
877-642-4691
Site Public Contact
877-642-4691
Kaiser Permanente-Modesto
Modesto, California 95356
Modesto, California 95356
Kaiser Permanente-Oakland
Oakland, California 94611
Oakland, California 94611
Kaiser Permanente-Roseville
Roseville, California 95661
Roseville, California 95661
Kaiser Permanente Downtown Commons
Sacramento, California 95814
Sacramento, California 95814
Kaiser Permanente-South Sacramento
Sacramento, California 95823
Sacramento, California 95823
Kaiser Permanente-San Francisco
San Francisco, California 94115
San Francisco, California 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
San Jose, California 95119
Kaiser Permanente San Leandro
San Leandro, California 94577
San Leandro, California 94577
Kaiser San Rafael-Gallinas
San Rafael, California 94903
San Rafael, California 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Santa Clara, California 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
Santa Rosa, California 95403
Kaiser Permanente-South San Francisco
South San Francisco, California 94080
South San Francisco, California 94080
Kaiser Permanente-Vallejo
Vallejo, California 94589
Vallejo, California 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Walnut Creek, California 94596
Saint Anthony Hospital
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii 96819
Honolulu, Hawaii 96819
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Boise, Idaho 83712
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Coeur d'Alene, Idaho 83814
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Fruitland, Idaho 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
Nampa, Idaho 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Post Falls, Idaho 83854
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
Sandpoint, Idaho 83864
Rush-Copley Medical Center
Aurora, Illinois 60504
Aurora, Illinois 60504
Advocate Outpatient Center - Aurora
Aurora, Illinois 60506
Aurora, Illinois 60506
Advocate Good Shepherd Hospital
Barrington, Illinois 60010
Barrington, Illinois 60010
Contact:
Site Public Contact
847-842-4847
Site Public Contact
847-842-4847
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
Illinois CancerCare-Carthage
Carthage, Illinois 62321
Carthage, Illinois 62321
Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
Chicago, Illinois 60657
Contact:
Site Public Contact
773-296-5360
Site Public Contact
773-296-5360
AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
Crystal Lake, Illinois 60014
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Illinois CancerCare-Dixon
Dixon, Illinois 61021
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800
Site Public Contact
815-285-7800
Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
Downers Grove, Illinois 60515
Carle Physician Group-Effingham
Effingham, Illinois 62401
Effingham, Illinois 62401
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Advocate Sherman Hospital
Elgin, Illinois 60123
Elgin, Illinois 60123
Contact:
Site Public Contact
847-429-2907
Site Public Contact
847-429-2907
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Eureka, Illinois 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
Hazel Crest, Illinois 60429
Contact:
Site Public Contact
708-799-9995
Site Public Contact
708-799-9995
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Kewanee, Illinois 61443
AMG Libertyville - Oncology
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Condell Memorial Hospital
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Illinois CancerCare-Macomb
Macomb, Illinois 61455
Macomb, Illinois 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Mattoon, Illinois 61938
Trinity Medical Center
Moline, Illinois 61265
Moline, Illinois 61265
Contact:
Site Public Contact
309-779-2000
Site Public Contact
309-779-2000
Carle BroMenn Medical Center
Normal, Illinois 61761
Normal, Illinois 61761
Carle Cancer Institute Normal
Normal, Illinois 61761
Normal, Illinois 61761
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
Oak Lawn, Illinois 60453-2699
Contact:
Site Public Contact
800-323-8622
Site Public Contact
800-323-8622
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois 60453
Oak Lawn, Illinois 60453
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Advocate High Tech Medical Park
Palos Heights, Illinois 60463
Palos Heights, Illinois 60463
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Park Ridge, Illinois 60068
Contact:
Site Public Contact
847-384-3621
Site Public Contact
847-384-3621
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Princeton, Illinois 61356
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Springfield Memorial Hospital
Springfield, Illinois 62781
Springfield, Illinois 62781
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
Mary Greeley Medical Center
Ames, Iowa 50010
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Ames
Ames, Iowa 50010
Ames, Iowa 50010
Saint Luke's Hospital
Cedar Rapids, Iowa 52402
Cedar Rapids, Iowa 52402
Mercy Hospital
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-365-4673
Site Public Contact
319-365-4673
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-363-2690
Site Public Contact
319-363-2690
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
Marshalltown, Iowa 50158
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Bemidji, Minnesota 56601
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota 56303
Saint Cloud, Minnesota 56303
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Freeman Health System
Joplin, Missouri 64804
Joplin, Missouri 64804
Mercy Hospital South
St Louis, Missouri 63128
St Louis, Missouri 63128
Mercy Hospital Saint Louis
St Louis, Missouri 63141
St Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Community Hospital of Anaconda
Anaconda, Montana 59711
Anaconda, Montana 59711
Billings Clinic Cancer Center
Billings, Montana 59101
Billings, Montana 59101
Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
Bozeman, Montana 59715
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Great Falls, Montana 59405
Logan Health Medical Center
Kalispell, Montana 59901
Kalispell, Montana 59901
Community Medical Center
Missoula, Montana 59804
Missoula, Montana 59804
Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
Bellevue, Nebraska 68123
Nebraska Methodist Hospital
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-354-5144
Site Public Contact
402-354-5144
Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
Omaha, Nebraska 68118
Contact:
Site Public Contact
402-559-5600
Site Public Contact
402-559-5600
University of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
Roswell Park Cancer Institute
Buffalo, New York 14263
Buffalo, New York 14263
Northwell Health Physicians Partners Radiation Medicine at Queens
Forest Hills, New York 11375
Forest Hills, New York 11375
Contact:
Site Public Contact
718-520-6620
Site Public Contact
718-520-6620
Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
Lake Success, New York 11042
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
Manhattan Eye Ear and Throat Hospital
New York, New York 10065
New York, New York 10065
Contact:
Site Public Contact
212-434-4460
Site Public Contact
212-434-4460
Lenox Hill Hospital
New York, New York 10075
New York, New York 10075
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
Queens Cancer Center
Rego Park, New York 11374
Rego Park, New York 11374
Contact:
Site Public Contact
718-312-3446
Site Public Contact
718-312-3446
Montefiore Medical Center-Einstein Campus
The Bronx, New York 10461
The Bronx, New York 10461
Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
The Bronx, New York 10467
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
Sanford Broadway Medical Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Aultman Health Foundation
Canton, Ohio 44710
Canton, Ohio 44710
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Geisinger Medical Center
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania 18519
Dickson City, Pennsylvania 18519
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Erie, Pennsylvania 16505
Saint Vincent Hospital
Erie, Pennsylvania 16544
Erie, Pennsylvania 16544
Contact:
Site Public Contact
814-452-5000
Site Public Contact
814-452-5000
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania 16121
Farrell, Pennsylvania 16121
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
Greensburg, Pennsylvania 15601
Contact:
Site Public Contact
724-838-1900
Site Public Contact
724-838-1900
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
Harrisburg, Pennsylvania 17109
Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
Jefferson Hills, Pennsylvania 15025
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Lewisburg, Pennsylvania 17837
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania 17050
Mechanicsburg, Pennsylvania 17050
Forbes Hospital
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
Contact:
Site Public Contact
412-858-7746
Site Public Contact
412-858-7746
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania 19114
Philadelphia, Pennsylvania 19114
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
Contact:
Site Public Contact
877-284-2000
Site Public Contact
877-284-2000
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073
Site Public Contact
412-647-8073
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-621-2334
Site Public Contact
412-621-2334
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania 15243
Pittsburgh, Pennsylvania 15243
Contact:
Site Public Contact
412-502-3920
Site Public Contact
412-502-3920
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania 17901
Pottsville, Pennsylvania 17901
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania 16346
Seneca, Pennsylvania 16346
Contact:
Site Public Contact
814-676-7900
Site Public Contact
814-676-7900
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
Wexford, Pennsylvania 15090
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
Willow Grove, Pennsylvania 19090
Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
Greer, South Carolina 29651
Spartanburg Medical Center
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
Farmington Health Center
Farmington, Utah 84025
Farmington, Utah 84025
University of Utah Sugarhouse Health Center
Salt Lake City, Utah 84106
Salt Lake City, Utah 84106
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
South Jordan Health Center
South Jordan, Utah 84009
South Jordan, Utah 84009
United Hospital Center
Bridgeport, West Virginia 26330
Bridgeport, West Virginia 26330
WVUH-Berkely Medical Center
Martinsburg, West Virginia 25401
Martinsburg, West Virginia 25401
West Virginia University Healthcare
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Camden Clark Medical Center
Parkersburg, West Virginia 26101
Parkersburg, West Virginia 26101
Princeton Community Hospital
Princeton, West Virginia 24740
Princeton, West Virginia 24740
Contact:
Site Public Contact
304-487-7515
Site Public Contact
304-487-7515
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia 26003
Wheeling, West Virginia 26003
Contact:
Site Public Contact
304-243-6442
Site Public Contact
304-243-6442
Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Antigo, Wisconsin 54409
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Burlington, Wisconsin 53105
Aurora Saint Luke's South Shore
Cudahy, Wisconsin 53110
Cudahy, Wisconsin 53110
Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Germantown, Wisconsin 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Grafton, Wisconsin 53024
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Green Bay, Wisconsin 54311
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Kenosha, Wisconsin 53142
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Marinette, Wisconsin 54143
Aspirus Medford Hospital
Medford, Wisconsin 54451
Medford, Wisconsin 54451
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
Menomonee Falls, Wisconsin 53051
Contact:
Site Public Contact
262-257-5100
Site Public Contact
262-257-5100
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666
Site Public Contact
414-805-3666
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Milwaukee, Wisconsin 53233
Drexel Town Square Health Center
Oak Creek, Wisconsin 53154
Oak Creek, Wisconsin 53154
Contact:
Site Public Contact
414-805-0505
Site Public Contact
414-805-0505
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Racine, Wisconsin 53406
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin 54501
Rhinelander, Wisconsin 54501
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin 54481
Stevens Point, Wisconsin 54481
Aurora Medical Center in Summit
Summit, Wisconsin 53066
Summit, Wisconsin 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
Two Rivers, Wisconsin 54241
Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Wausau, Wisconsin 54401
Contact:
Site Public Contact
877-405-6866
Site Public Contact
877-405-6866
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
Aurora West Allis Medical Center
West Allis, Wisconsin 53227
West Allis, Wisconsin 53227
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin 53095
West Bend, Wisconsin 53095
Contact:
Site Public Contact
414-805-0505
Site Public Contact
414-805-0505
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
Wisconsin Rapids, Wisconsin 54494
Contact:
Site Public Contact
715-422-7718
Site Public Contact
715-422-7718
More Details
- Status
- Recruiting
- Sponsor
- Alliance for Clinical Trials in Oncology
Detailed Description
PRIMARY OBJECTIVE: I. To determine whether prophylactic high dose gabapentin, titrated to a dose of 3600 mg (1200 mg three times per day [TID]), is superior to placebo in increasing the proportion of patients not needing opiates while undergoing chemoradiation therapy. SECONDARY OBJECTIVES: I. To determine whether prophylactic high dose gabapentin is superior to placebo in prolonging the time to first opioid use while undergoing chemoradiation therapy. II. To determine whether prophylactic high dose gabapentin is superior to placebo in improving patient reported pain scores using the 0-10 numerical rating scale (NRS) from baseline to 4 weeks after the end of chemoradiation therapy. EXPLORATORY OBJECTIVES: I. To explore the duration of opioid use from the time of initiation to cessation by arm as well as describe the proportion of patients remaining on opioids at 3 months, 6 months, and 1 year by arm. II. To explore the trajectory of patient reported symptom and quality of life outcomes using the Oral Mucositis Weekly Questionnaire (OMWQ) by arm. III. To explore the trajectory of patient reported symptom and quality of life outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-30) by arm. IV. To explore the trajectory of patient reported symptom and quality of life outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck-43 (EORTC QLQ-H&N43) by arm. V. To evaluate the adverse event profiles of prophylactic high dose gabapentin versus placebo. VI. To assess the tolerance of high dose gabapentin. VII. To explore the trajectory of patient health using patient body mass index (BMI) and creatinine, absolute neutrophil count (ANC) as routinely obtained by arm. VIII. To describe the incidence of feeding tube requirement during and after chemoradiation therapy by arm. IX. To describe the dose of prescribed opioids standardized using the Morphine Milligram Equivalent calculator by arm. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Starting by radiation treatment 8, patients receive placebo orally (PO) once daily (QD) on day 1, twice daily (BID) on day 2, then three times daily (TID) starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with placebo continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive placebo TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study. ARM II: Starting by radiation treatment 8, patients receive gabapentin PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with gabapentin continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive gabapentin TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up at 4 weeks, 3 months and 6 months after the last dose of chemoradiation therapy.