Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery
- Conditions
- Unspecified Adult Solid Tumor, Protocol SpecificPain
- Interventions
- Other: placebo
- Registration Number
- NCT00058357
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: A lidocaine patch may be effective in relieving numbness, tingling, and other symptoms of neuropathy. It is not yet known whether a lidocaine patch is effective in treating neuropathy in patients who have undergone surgery for cancer.
PURPOSE: This randomized phase III trial is studying lidocaine patch to see how well it works compared to a placebo patch in relieving numbness, tingling, and other symptoms of neuropathy in patients who have undergone surgery for cancer.
- Detailed Description
OBJECTIVES:
* Determine whether a lidocaine patch vs placebo improves postsurgical neuropathic pain in cancer patients.
* Compare the toxic effects of these regimens in these patients.
* Compare the effect of these regimens on mood states, functional abilities, and overall quality of life of these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to etiology of pain (breast surgery vs lung surgery vs amputation vs other), duration of pain (1-3 months vs 4-6 months vs more than 6 months), and current analgesic regimen (opioids \[including tramadol\] vs antidepressants vs anticonvulsants vs combination vs other vs none). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive a lidocaine transdermal patch (up to 3 patches) applied directly to the painful area for 18 hours once daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity. At the end of week 4, patients cross over to arm II.
* Arm II: Patients receive a placebo transdermal patch applied to the painful area as in arm I. At the end of week 4, patients cross over to arm I.
Pain and quality of life are assessed at baseline and weeks 4 and 8.
Patients are followed at 3-7 days.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo patch placebo Participants will be instructed to apply a patch or patches (up to 3 maximum simultaneously) directly to the affected area. The patch(es) should be applied during awake hours and then left on continuously for approximately 18 hours or until usual bedtime sleep. Lidocaine patch lidocaine Participants will be instructed to apply a patch or patches (up to 3 maximum simultaneously) directly to the affected area. The patch(es) should be applied during awake hours and then left on continuously for approximately 18 hours or until usual bedtime sleep.
- Primary Outcome Measures
Name Time Method Pain intensity rating (NRS) 4 and 8 weeks
- Secondary Outcome Measures
Name Time Method Pain as assessed by the Brief Pain Inventory-Short Form, Neuropathy Pain Scale, Subject Global Impression of Change, Pain Catastrophizing Scale, Profile of Mood States Short Form, and NCCTG Quality of Life 8 weeks Incidence of each toxicity reported in each treatment period 8 weeks Maximum severity reported of each toxicity 8 weeks Distribution of the overall toxicity score 8 weeks Proportion of patients who report a preference for lidocaine patch or placebo at study completion 8 weeks Proportion of patients who terminate treatment prematurely up to 8 weeks
Trial Locations
- Locations (156)
Mason District Hospital
🇺🇸Havana, Illinois, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
St. Joseph's Medical Center
🇺🇸Brainerd, Minnesota, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
Mercy Memorial Hospital System
🇺🇸Monroe, Michigan, United States
Chippewa County - Montevideo Hospital
🇺🇸Montevideo, Minnesota, United States
Deaconess Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
St. Mary's - Duluth Clinic Cancer Center
🇺🇸Duluth, Minnesota, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Internal Medicine Associates of Bozeman
🇺🇸Bozeman, Montana, United States
Miller-Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Haematology-Oncology Associates of Ohio and Michigan, P.C.
🇺🇸Lambertville, Michigan, United States
Park Nicollet Health Services
🇺🇸St. Louis Park, Minnesota, United States
Deaconess Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Sletten Regional Cancer Institute
🇺🇸Great Falls, Montana, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
🇺🇸Anderson, South Carolina, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Promedica Cancer Center at Flower Hospital
🇺🇸Sylvania, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
United States Air Force Medical Center Wright-Patterson
🇺🇸Wright-Patterson Afb, Ohio, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Toledo Surgical Specialists
🇺🇸Toledo, Ohio, United States
Cancer Center of Kansas, P.A. - Winfield
🇺🇸Winfield, Kansas, United States
Associates in Womens Health, P.A. - North Review
🇺🇸Wichita, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons
🇺🇸Parsons, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Cancer Center of Kansas, P.A. - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, P.A. - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, P.A. - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, P.A. - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, P.A. - Wellington
🇺🇸Wellington, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Pratt
🇺🇸Pratt, Kansas, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
St. James Community Hospital
🇺🇸Butte, Montana, United States
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
Saint Francis Cancer Center
🇺🇸Shakopee, Minnesota, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸St. Paul, Minnesota, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Providence Hospital
🇺🇸Washington, District of Columbia, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
MBCCOP-Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Cancer Care Center at Medcenter One Hospital
🇺🇸Bismarck, North Dakota, United States
Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Mercy Regional Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Reid Hospital & Health Care Services, Incorporated
🇺🇸Richmond, Indiana, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Siouxland Hematology-Oncology Associates
🇺🇸Sioux City, Iowa, United States
Brainerd Medical Center
🇺🇸Brainerd, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸Lichfield, Minnesota, United States
St. Joseph's Hospital
🇺🇸St Paul, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Kalispell Medical Oncology
🇺🇸Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Mid Dakota Clinic, P. C.
🇺🇸Bismarck, North Dakota, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Kenton Oncology, Incorporated
🇺🇸Kenton, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Cancer Center of Kansas, P.A. - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Eastern Montana Cancer Center
🇺🇸Miles City, Montana, United States