- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00516503
Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
The Use of Topical Baclofen, Amitriptyline HCI, and Ketamine (BAK) in a PLO Gel vs. Placebo for the Treatment of Chemotherapy Induced Peripheral Neuropathy: A Phase III Randomized Double-Blind Placebo Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES Primary
- 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 neuropathy in these patients.
- Assess the adverse event profile of topical BAK gel.
- Explore whether topical BAK gel is absorbed systemically. 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259-5499
- Mayo Clinic Scottsdale
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic - Jacksonville
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Illinois
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Aurora, Illinois, United States, 60504
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, United States, 61701
- St. Joseph Medical Center
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Canton, Illinois, United States, 61520
- Graham Hospital
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Carthage, Illinois, United States, 62321
- Memorial Hospital
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Eureka, Illinois, United States, 61530
- Eureka Community Hospital
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Galesburg, Illinois, United States, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, United States, 61401
- Galesburg Clinic, PC
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Havana, Illinois, United States, 62644
- Mason District Hospital
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Hopedale, Illinois, United States, 61747
- Hopedale Medical Complex
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Joliet, Illinois, United States, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Macomb, Illinois, United States, 61455
- Mcdonough District Hospital
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Moline, Illinois, United States, 61265
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Normal, Illinois, United States, 61761
- Community Cancer Center
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Ottawa, Illinois, United States, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, United States, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, United States, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, United States, 61614
- Proctor Hospital
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Peoria, Illinois, United States, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, United States, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, United States, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, United States, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, United States, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, United States, 61362
- St. Margaret's Hospital
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Urbana, Illinois, United States, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, United States, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Elkhart, Indiana, United States, 46515
- Elkhart General Hospital
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Kokomo, Indiana, United States, 46904
- Howard Community Hospital
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La Porte, Indiana, United States, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Michigan City, Indiana, United States, 46360
- Saint Anthony Memorial Health Centers
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Richmond, Indiana, United States, 47374
- Reid Hospital & Health Care Services
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South Bend, Indiana, United States, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, United States, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Ames, Iowa, United States, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, United States, 52722
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Cedar Rapids, Iowa, United States, 52403
- Cedar Rapids Oncology Associates
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Sioux City, Iowa, United States, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, United States, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, United States, 51104
- Mercy Medical Center - Sioux City
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Michigan
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Adrian, Michigan, United States, 49221
- Hickman Cancer Center at Bixby Medical Center
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Lambertville, Michigan, United States, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Monroe, Michigan, United States, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, United States, 48162
- Mercy Memorial Hospital - Monroe
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Saint Joseph, Michigan, United States, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Minnesota
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Bemidji, Minnesota, United States, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, United States, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Duluth, Minnesota, United States, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, United States, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, United States, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Mankato, Minnesota, United States, 56002
- Immanuel St. Joseph's
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Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Minneapolis, Minnesota, United States, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Robbinsdale, Minnesota, United States, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, United States, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, United States, 55102
- United Hospital
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Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, United States, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Montana
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Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, United States, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, United States, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, United States, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, United States, 59107-7000
- Billings Clinic - Downtown
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Butte, Montana, United States, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, United States, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, United States, 59405
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Great Falls, Montana, United States, 59405-5309
- Big Sky Oncology
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Great Falls, Montana, United States, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Kalispell, Montana, United States, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, United States, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, United States, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, United States, 59801
- Community Medical Center
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Missoula, Montana, United States, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, United States, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, United States, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Lincoln, Nebraska, United States, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, United States, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, United States, 68122
- Immanuel Medical Center
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Omaha, Nebraska, United States, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, United States, 68131-2197
- Creighton University Medical Center
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North Carolina
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Rutherfordton, North Carolina, United States, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, United States, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, United States, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, United States, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, United States, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, United States, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, United States, 58122
- MeritCare Broadway
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Grand Forks, North Dakota, United States, 58201
- Altru Cancer Center at Altru Hospital
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Ohio
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Bellefontaine, Ohio, United States, 43311
- Mary Rutan Hospital
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Bowling Green, Ohio, United States, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, United States, 45601
- Adena Regional Medical Center
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Clyde, Ohio, United States, 43410
- North Coast Cancer Care - Clyde
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Columbus, Ohio, United States, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, United States, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, United States, 43215
- CCOP - Columbus
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Columbus, Ohio, United States, 43215
- Grant Medical Center Cancer Care
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Columbus, Ohio, United States, 43228
- Doctors Hospital at Ohio Health
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Dayton, Ohio, United States, 45405
- Grandview Hospital
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Dayton, Ohio, United States, 45406
- Good Samaritan Hospital
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Dayton, Ohio, United States, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, United States, 45429
- CCOP - Dayton
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Delaware, Ohio, United States, 43015
- Grady Memorial Hospital
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Elyria, Ohio, United States, 44035
- Hematology Oncology Center
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Findlay, Ohio, United States, 45840
- Blanchard Valley Medical Associates
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Franklin, Ohio, United States, 45005-1066
- Middletown Regional Hospital
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Kettering, Ohio, United States, 45429
- Charles F. Kettering Memorial Hospital
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Lancaster, Ohio, United States, 43130
- Fairfield Medical Center
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Lima, Ohio, United States, 45804
- Lima Memorial Hospital
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Marietta, Ohio, United States, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Maumee, Ohio, United States, 43537
- Northwest Ohio Oncology Center
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Maumee, Ohio, United States, 43537
- St. Luke's Hospital
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Newark, Ohio, United States, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Oregon, Ohio, United States, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, United States, 43616
- Toledo Clinic - Oregon
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Sandusky, Ohio, United States, 44870
- North Coast Cancer Care, Incorporated
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Springfield, Ohio, United States, 45505
- Community Hospital of Springfield and Clark County
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Springfield, Ohio, United States, 45504
- Mercy Medical Center
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Sylvania, Ohio, United States, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, United States, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, United States, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, United States, 43606
- Toledo Hospital
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Toledo, Ohio, United States, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, United States, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, United States, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, United States, 43623
- St. Anne Mercy Hospital
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Troy, Ohio, United States, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wauseon, Ohio, United States, 43567
- Fulton County Health Center
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Westerville, Ohio, United States, 43081
- Mount Carmel St. Ann's Cancer Center
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Wilmington, Ohio, United States, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, United States, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Zanesville, Ohio, United States, 43701
- Genesis - Good Samaritan Hospital
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Oregon
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Gresham, Oregon, United States, 97030
- Legacy Mount Hood Medical Center
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Milwaukie, Oregon, United States, 97222
- Providence Milwaukie Hospital
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Portland, Oregon, United States, 97216
- Adventist Medical Center
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Portland, Oregon, United States, 97210
- Legacy Good Samaritan Hospital & Comprehensive Cancer Center
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Portland, Oregon, United States, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
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Portland, Oregon, United States, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, United States, 97225
- Providence St. Vincent Medical Center
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Portland, Oregon, United States, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Tualatin, Oregon, United States, 97062
- Legacy Meridian Park Hospital
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hazleton, Pennsylvania, United States, 18201
- Geisinger Hazleton Cancer Center
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Sayre, Pennsylvania, United States, 18840
- Guthrie Cancer Center at Guthrie Clinic Sayre
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State College, Pennsylvania, United States, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, United States, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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Wilkes-Barre, Pennsylvania, United States, 18765
- Mercy Hospital at Wilkes-Barre
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South Carolina
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Anderson, South Carolina, United States, 29621
- AnMed Cancer Center
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Spartanburg, South Carolina, United States, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, United States, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, United States, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Virginia
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Fredericksburg, Virginia, United States, 22401
- Fredericksburg Oncology, Incorporated
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Washington
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Vancouver, Washington, United States, 98668
- Southwest Washington Medical Center Cancer Center
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Wisconsin
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La Crosse, Wisconsin, United States, 54601
- Franciscan Skemp Healthcare - La Crosse Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:>
- Diagnosis of cancer>
- Received or currently receiving neurotoxic chemotherapy including, but not limited to, taxanes (e.g., paclitaxel or docetaxel); platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin); vinca alkaloids (e.g., vincristine or vinblastine); or other neurotoxic chemotherapy agents (e.g., bortezomib, lenalidomide, or thalidomide)>
Must have pain or symptoms of peripheral neuropathy attributable to chemotherapy for ≥ 1 month>
- Neuropathy is limited to either hands and/or feet where gel can be applied>
- Neuropathic pain score of ≥ 4 out of 10 on the numbness/tingling/pain numeric analogue scale>
- No pre-existing or history of peripheral neuropathy due to any cause other than chemotherapy (e.g., diabetes, alcohol, toxin, heredity)> PATIENT CHARACTERISTICS:>
- ECOG performance status 0-2>
- Life expectancy ≥ 4 months>
- Creatinine ≤ 1.5 times upper limit of normal>
- Not pregnant or nursing>
No ability to bear children defined by 1 of the criteria:>
- Menopausal (12 months and no menstrual period if natural menopause)>
- Underwent a hysterectomy and/or oophorectomy>
- Permanent surgical sterilization (tubal ligation)>
- Fertile patients must use effective contraception>
- Able to complete questionnaires independently or with assistance>
- Able to sign informed consent and understand the nature of a placebo-controlled trial>
- No history of an allergic reaction to baclofen, amitriptyline hydrochloride, and/or ketamine>
- No diagnosis of any New York Heart Association class I-IV congestive heart failure>
- No diagnosis of coronary artery disease including, but not limited to, myocardial infarction, within the past 5 years>
- No other medical condition that, in the opinion of the treating physician or allied health professional, would make this clinical trial unreasonably hazardous for the patient>
- No skin abnormalities at the intended application sites (hands and feet) of study gel (i.e., skin breakdown)> PRIOR CONCURRENT THERAPY:>
- See Disease Characteristics>
More than 30 days since prior anticonvulsants, tricyclic antidepressants, monoamine oxidase inhibitor, or other neuropathic pain medication (e.g., carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch or gel, capsaicin cream, or amifostine)>
- Patients treated with any of these agents for peripheral neuropathy for ≤ 1 week during the past 30 days are eligible provided they are no longer taking the agent>
More than 5 years since prior percutaneous transluminal coronary angioplasty or coronary artery bypass graft>
- Prior heart valve replacement surgery allowed provided patient has fully recovered from the surgery>
- No concurrent use of study agents other than as specified in the trial>
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Applied topically
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Placebo Comparator: 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.
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Applied topically
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Sensory Neuropathy as Measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life [QLQ] - Chemo-induced Peripheral Neuropathy [CIPN20]
Time Frame: From baseline to 4 weeks
|
The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0-100 scales so that a high score corresponds to better condition or less symptom.
The primary analysis was the change in sensory neuropathy subscale of the CIPN-20 from baseline to week 4.
The area under the curve (AUC) from baseline to week 4 was calculated for each patient's sensory neuropathy score.
The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.
|
From baseline to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4
Time Frame: From Baseline to week 4
|
The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0-100 scales so that a high score corresponds to better condition or less symptom.
The secondary analysis was to compare changes from baseline at 4 weeks for the motor neuropathy subscale of the CIPN-20.
To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score.
The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.
|
From Baseline to week 4
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Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4
Time Frame: Up to 4 weeks
|
The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0-100 scales so that a high score corresponds to better condition or less symptom.
The secondary analysis was to compare changes from baseline at 4 weeks for the autonomic neuropathy subscale of the CIPN-20.
To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score.
The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.
|
Up to 4 weeks
|
Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS)
Time Frame: At 4 weeks
|
Each mood scale (0 - 100, higher is better mood) will be analyzed as an endpoint along with the total mood disturbance score.
|
At 4 weeks
|
Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4
Time Frame: Up to 4 weeks
|
Pain severity, defined by the four items addressing worst, least, and average pain and pain right now as measured by the BPI will be analyzed identical to the primary endpoint.
Additionally, total pain interference as measured by the BPI will be transformed onto a 0-100 ( higher is less pain) point scale.
The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score.
The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.
|
Up to 4 weeks
|
Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks
Time Frame: Up to 4 weeks
|
The Peripheral Neuropathy Questionnaire was used to analyze this endpoint.
Patient neuropathy symptoms were scored on a 0 - 100 scale (higher score represents less symptomatic).
The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score.
The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.
|
Up to 4 weeks
|
Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > Frequency and Severity of Adverse Events Reported by the Patient in the > Symptom Experience Diary and Evaluated Through Clinical Assessment by NCI CTCAE v3.0
Time Frame: Up to 4 weeks
|
Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0.
The number of patients reporting grade 3 or higher events are reported in this outcome measure.
For a full list of all events, please refer to the Adverse Events section of this report.
|
Up to 4 weeks
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Wolf SL, Barton DL, Qin R, Wos EJ, Sloan JA, Liu H, Aaronson NK, Satele DV, Mattar BI, Green NB, Loprinzi CL. The relationship between numbness, tingling, and shooting/burning pain in patients with chemotherapy-induced peripheral neuropathy (CIPN) as measured by the EORTC QLQ-CIPN20 instrument, N06CA. Support Care Cancer. 2012 Mar;20(3):625-32. doi: 10.1007/s00520-011-1141-9. Epub 2011 Apr 12.
- Barton DL, Wos EJ, Qin R, Mattar BI, Green NB, Lanier KS, Bearden JD 3rd, Kugler JW, Hoff KL, Reddy PS, Rowland KM Jr, Riepl M, Christensen B, Loprinzi CL. A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA. Support Care Cancer. 2011 Jun;19(6):833-41. doi: 10.1007/s00520-010-0911-0. Epub 2010 May 25.
- Barton DL, Wos E, Qin R, et al.: A randomized controlled trial evaluating a topical treatment for chemotherapy-induced neuropathy: NCCTG trial N06CA. [Abstract] J Clin Oncol 27 (Suppl 15): A-9531, 2009.
- Wolf SL, Qin R, Barton DL, et al.: Relationship of sensory symptoms and motor function in patients with chemotherapy-induced peripheral neuropathy (CIPN) utilizing the EORTC QLQ CIPN20: NCCTG study N06CA. [Abstract] J Clin Oncol 27 (Suppl 15): A-9587, 2009.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Neuromuscular Diseases
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms
- Myelodysplastic Syndromes
- Disease
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Peripheral Nervous System Diseases
- Plasmacytoma
- Lymphoproliferative Disorders
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Non-Narcotic
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- GABA Agents
- Antidepressive Agents, Tricyclic
- Neuromuscular Agents
- Adrenergic Uptake Inhibitors
- Muscle Relaxants, Central
- GABA Agonists
- GABA-B Receptor Agonists
- Ketamine
- Amitriptyline
- Baclofen
Other Study ID Numbers
- NCCTG-N06CA
- NCI-2011-01768 (Registry Identifier: CTRP (Clinical Trials Reporting System))
- CDR0000560732 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
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University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
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Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
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Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
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Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
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George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
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Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
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Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
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Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
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susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
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University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on placebo
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SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
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National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
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Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
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West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States