RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused
by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in
treating peripheral neuropathy caused by chemotherapy .
PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works
compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients
with cancer.
- Compare the effectiveness of baclofen-amitriptyline hydrochloride-ketamine (BAK) gel
versus placebo, in terms of improving sensory neuropathy, in cancer patients with
chemotherapy-induced peripheral neuropathy.
Secondary
- Compare motor and autonomic symptoms and functioning, mood states, pain, and peripheral
OUTLINE: Patients are stratified according to neurotoxic chemotherapy (active vs
non-active), current use of opioids or oral pain medications (yes vs no), pain rating (4-7
vs 8-10), and prior ineffective pharmacologic treatment for peripheral neuropathy (yes vs
no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel
topically to each area of pain, numbness, and/or tingling on the feet and/or hands
twice daily for 4 weeks.
- Arm II: Patients apply 1 spoonful of placebo gel topically to each area of pain,
numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.
Some patients in both arms may choose to continue on the active gel or, if on placebo, begin
the active gel for an additional 8 weeks off study.
Patients complete health, pain, mood, and quality of life questionnaires at baseline and
periodically during study. Patients also record adverse symptoms weekly in a Symptom
Experience Diary.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Mayo Clinic Scottsdale, Scottsdale, Arizona 85259-5499, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States
Rush-Copley Cancer Care Center, Aurora, Illinois 60504, United States
St. Joseph Medical Center, Bloomington, Illinois 61701, United States
Graham Hospital, Canton, Illinois 61520, United States
Memorial Hospital, Carthage, Illinois 62321, United States
Eureka Community Hospital, Eureka, Illinois 61530, United States
Galesburg Clinic, PC, Galesburg, Illinois 61401, United States
Galesburg Cottage Hospital, Galesburg, Illinois 61401, United States
Mason District Hospital, Havana, Illinois 62644, United States
Hopedale Medical Complex, Hopedale, Illinois 61747, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States
McDonough District Hospital, Macomb, Illinois 61455, United States
Moline, Illinois 61265, United States
Community Cancer Center, Normal, Illinois 61761, United States
Community Hospital of Ottawa, Ottawa, Illinois 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois 61350, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois 61554, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615, United States
Methodist Medical Center of Illinois, Peoria, Illinois 61636, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois 61615, United States
OSF St. Francis Medical Center, Peoria, Illinois 61637, United States
Proctor Hospital, Peoria, Illinois 61614, United States
Illinois Valley Community Hospital, Peru, Illinois 61354, United States
Perry Memorial Hospital, Princeton, Illinois 61356, United States
St. Margaret's Hospital, Spring Valley, Illinois 61362, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana 46107, United States
Elkhart General Hospital, Elkhart, Indiana 46515, United States
Howard Community Hospital, Kokomo, Indiana 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana 46350, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States
Reid Hospital & Health Care Services, Richmond, Indiana 47374, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States
Memorial Hospital of South Bend, South Bend, Indiana 46601, United States
Saint Joseph Regional Medical Center, South Bend, Indiana 46617, United States
McFarland Clinic, PC, Ames, Iowa 50010, United States
Bettendorf, Iowa 52722, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa 52403, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, United States
St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States
Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan 49221, United States
Haematology-Oncology Associates of Ohio and Michigan, PC, Lambertville, Michigan 48144, United States
Community Cancer Center of Monroe, Monroe, Michigan 48162, United States
Mercy Memorial Hospital - Monroe, Monroe, Michigan 48162, United States
Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan 49085, United States
MeritCare Bemidji, Bemidji, Minnesota 56601, United States
Fairview Ridges Hospital, Burnsville, Minnesota 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota 55433, United States
CCOP - Duluth, Duluth, Minnesota 55805, United States
Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota 55805-1983, United States
Miller - Dwan Medical Center, Duluth, Minnesota 55805, United States
Fairview Southdale Hospital, Edina, Minnesota 55435, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota 55432, United States
Immanuel St. Joseph's, Mankato, Minnesota 56002, United States
Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota 55422-2900, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota 55416, United States
United Hospital, Saint Paul, Minnesota 55102, United States
Ridgeview Medical Center, Waconia, Minnesota 55387, United States
Willmar Cancer Center at Rice Memorial Hospital, Willmar, Minnesota 56201, United States
Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota 55125, United States
Billings Clinic - Downtown, Billings, Montana 59107-7000, United States
CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana 59101, United States
Northern Rockies Radiation Oncology Center, Billings, Montana 59101, United States
St. Vincent Healthcare Cancer Care Services, Billings, Montana 59101, United States
St. James Healthcare Cancer Care, Butte, Montana 59701, United States
Great Falls, Montana 59405, United States
Big Sky Oncology, Great Falls, Montana 59405-5309, United States
Great Falls Clinic - Main Facility, Great Falls, Montana 59405, United States
Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana 59405, United States
Glacier Oncology, PLLC, Kalispell, Montana 59901, United States
Kalispell Medical Oncology at KRMC, Kalispell, Montana 59901, United States
Kalispell Regional Medical Center, Kalispell, Montana 59901, United States
Community Medical Center, Missoula, Montana 59801, United States
Guardian Oncology and Center for Wellness, Missoula, Montana 59804, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana 59807, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana 59807-7877, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska 68510, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha, Nebraska 68124, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States
Creighton University Medical Center, Omaha, Nebraska 68131-2197, United States
Immanuel Medical Center, Omaha, Nebraska 68122, United States
Rutherford Hospital, Rutherfordton, North Carolina 28139, United States
Bismarck Cancer Center, Bismarck, North Dakota 58501, United States
Medcenter One Hospital Cancer Care Center, Bismarck, North Dakota 58501, United States
Mid Dakota Clinic, PC, Bismarck, North Dakota 58501, United States
St. Alexius Medical Center Cancer Center, Bismarck, North Dakota 58502, United States
CCOP - MeritCare Hospital, Fargo, North Dakota 58122, United States
MeritCare Broadway, Fargo, North Dakota 58122, United States
Altru Cancer Center at Altru Hospital, Grand Forks, North Dakota 58201, United States
Mary Rutan Hospital, Bellefontaine, Ohio 43311, United States
Wood County Oncology Center, Bowling Green, Ohio 43402, United States
Adena Regional Medical Center, Chillicothe, Ohio 45601, United States
North Coast Cancer Care - Clyde, Clyde, Ohio 43410, United States
CCOP - Columbus, Columbus, Ohio 43215, United States
Doctors Hospital at Ohio Health, Columbus, Ohio 43228, United States
Grant Medical Center Cancer Care, Columbus, Ohio 43215, United States
Mount Carmel Health - West Hospital, Columbus, Ohio 43222, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio 43214-3998, United States
CCOP - Dayton, Dayton, Ohio 45429, United States
Good Samaritan Hospital, Dayton, Ohio 45406, United States
Grandview Hospital, Dayton, Ohio 45405, United States
Samaritan North Cancer Care Center, Dayton, Ohio 45415, United States
Grady Memorial Hospital, Delaware, Ohio 43015, United States
Hematology Oncology Center, Elyria, Ohio 44035, United States
Blanchard Valley Medical Associates, Findlay, Ohio 45840, United States
Middletown Regional Hospital, Franklin, Ohio 45005-1066, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio 45429, United States
Fairfield Medical Center, Lancaster, Ohio 43130, United States
Lima Memorial Hospital, Lima, Ohio 45804, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio 45750, United States
Northwest Ohio Oncology Center, Maumee, Ohio 43537, United States
St. Luke's Hospital, Maumee, Ohio 43537, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio 43055, United States
St. Charles Mercy Hospital, Oregon, Ohio 43616, United States
Toledo Clinic - Oregon, Oregon, Ohio 43616, United States
North Coast Cancer Care, Incorporated, Sandusky, Ohio 44870, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio 45505, United States
Mercy Medical Center, Springfield, Ohio 45504, United States
Flower Hospital Cancer Center, Sylvania, Ohio 43560, United States
Mercy Hospital of Tiffin, Tiffin, Ohio 44883, United States
CCOP - Toledo Community Hospital, Toledo, Ohio 43617, United States
Medical University of Ohio Cancer Center, Toledo, Ohio 43614, United States
St. Anne Mercy Hospital, Toledo, Ohio 43623, United States
St. Vincent Mercy Medical Center, Toledo, Ohio 43608, United States
Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio 43623, United States
Toledo Hospital, Toledo, Ohio 43606, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio 45373-1300, United States
Fulton County Health Center, Wauseon, Ohio 43567, United States
Mount Carmel St. Ann's Cancer Center, Westerville, Ohio 43081, United States
Clinton Memorial Hospital, Wilmington, Ohio 45177, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio 45385, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio 43701, United States
Legacy Mount Hood Medical Center, Gresham, Oregon 97030, United States
Providence Milwaukie Hospital, Milwaukie, Oregon 97222, United States
Adventist Medical Center, Portland, Oregon 97216, United States
CCOP - Columbia River Oncology Program, Portland, Oregon 97225, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon 97227, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center, Portland, Oregon 97210, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon 97213-2967, United States
Providence St. Vincent Medical Center, Portland, Oregon 97225, United States
Legacy Meridian Park Hospital, Tualatin, Oregon 97062, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania 17822-0001, United States
Geisinger Hazleton Cancer Center, Hazleton, Pennsylvania 18201, United States
Guthrie Cancer Center at Guthrie Clinic Sayre, Sayre, Pennsylvania 18840, United States
Geisinger Medical Group - Scenery Park, State College, Pennsylvania 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania 18711, United States
Mercy Hospital at Wilkes-Barre, Wilkes-Barre, Pennsylvania 18765, United States
AnMed Cancer Center, Anderson, South Carolina 29621, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States
Rapid City Regional Hospital, Rapid City, South Dakota 57701, United States
Avera Cancer Institute, Sioux Falls, South Dakota 57105, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota 57105, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota 57117-5039, United States
Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia 22401, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington 98668, United States
Franciscan Skemp Healthcare - La Crosse Campus, La Crosse, Wisconsin 54601, United States