Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
- Conditions
- Myelodysplastic/Myeloproliferative NeoplasmsLymphomaLymphoproliferative DisorderChronic Myeloproliferative DisordersMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesLeukemiaPainUnspecified Adult Solid Tumor, Protocol SpecificNeurotoxicity
- Interventions
- Drug: baclofen/amitriptyline/ketamine gelOther: placebo
- Registration Number
- NCT00516503
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I baclofen/amitriptyline/ketamine gel 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 placebo 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.
- Primary Outcome Measures
Name Time Method 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] 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.
- Secondary Outcome Measures
Name Time Method Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4 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.
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 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.
Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks 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.
Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4 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.
Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS) 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.
Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4 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.
Trial Locations
- Locations (162)
Graham Hospital
🇺🇸Canton, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Medcenter One Hospital Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
MeritCare Bemidji
🇺🇸Bemidji, Minnesota, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Miller - Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
Immanuel St. Joseph's
🇺🇸Mankato, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸Maplewood, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
🇺🇸Robbinsdale, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Park Nicollet Cancer Center
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
Mary Rutan Hospital
🇺🇸Bellefontaine, Ohio, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
North Coast Cancer Care - Clyde
🇺🇸Clyde, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Hematology Oncology Center
🇺🇸Elyria, Ohio, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Mercy Medical Center
🇺🇸Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
St. Anne Mercy Hospital
🇺🇸Toledo, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Clinton Memorial Hospital
🇺🇸Wilmington, Ohio, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Legacy Mount Hood Medical Center
🇺🇸Gresham, Oregon, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Guthrie Cancer Center at Guthrie Clinic Sayre
🇺🇸Sayre, Pennsylvania, United States
Legacy Meridian Park Hospital
🇺🇸Tualatin, Oregon, United States
Geisinger Hazleton Cancer Center
🇺🇸Hazleton, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health
🇺🇸Danville, Pennsylvania, United States
Geisinger Medical Group - Scenery Park
🇺🇸State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Mercy Hospital at Wilkes-Barre
🇺🇸Wilkes-Barre, Pennsylvania, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Fredericksburg Oncology, Incorporated
🇺🇸Fredericksburg, Virginia, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
Franciscan Skemp Healthcare - La Crosse Campus
🇺🇸La Crosse, Wisconsin, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
MeritCare Broadway
🇺🇸Fargo, North Dakota, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Adventist Medical Center
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
🇺🇸Portland, Oregon, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States