Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery

Last updated: June 27, 2016
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Completed

Phase

3

Condition

Pain

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00058357
NCCTG-N01CB
CDR0000288824
NCCTG-N01CB
  • Ages 18-120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Underwent surgical procedure for cancer diagnosis or treatment

  • Experiencing persistent pain for at least 1 month

  • Pain must have neuropathic features (e.g., burning, shooting, stabbing, tingling, or pain from light touch)

  • Anatomically related to the surgical site and compatible with nerve injury

  • Pain rating of at least 4 out of 10 on the pain scale

  • No pain of multiple etiologies at the proposed treatment site (e.g., pain of neuropathic and muscular or skeletal origin)

  • Painful area must be no larger than can be covered by 3 lidocaine patches* NOTE: *Each patch size is 5.5 x 4 inches

  • No skin disease, breakdown, infection, or extreme thinning at the site of pain

  • No skin or soft tissue malignancy in the painful area

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • At least 6 months

Hematopoietic

  • Not specified

Hepatic

  • AST ≤ 2 times upper limit of normal

Renal

  • Not specified

Other

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective contraception

  • Able to understand and complete questionnaires

  • No recent history of or concurrent drug or alcohol abuse

  • No mental or psychiatric condition that would preclude giving informed consent

  • No history of allergic reaction or intolerance to lidocaine or other amide local anesthetics (e.g., bupivacaine)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior neurotoxic chemotherapy* with pain in the same area as postsurgical neuropathic pain, except for pain that was present before neurotoxic chemotherapy administration

  • No concurrent neurotoxic chemotherapy* NOTE: *Including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., cisplatin or carboplatin), or vinca alkaloids (e.g., vincristine or vinblastine)

Endocrine therapy

  • More than 7 days since prior topical corticosteroids to the painful area

  • No new corticosteroids may be initiated during study participation

Radiotherapy

  • No concurrent radiotherapy to the painful area

Surgery

  • See Disease Characteristics

Other

  • More than 7 days since other prior topical medications to the painful area (including capsaicin)

  • No change in current analgesic regimen within the past 10 days

  • No new analgesic or adjuvant drugs (e.g., antidepressants, anticonvulsants, or anxiolytics) may be initiated during study participation

  • Concurrent stable doses of nonopioid, opioid, and adjuvant analgesic drugs are allowed (including antidepressants or anticonvulsants)

  • No concurrent class I antiarrhythmic drugs (e.g., tocainide and mexiletine)

  • Concurrent skin lubricants and sunscreen are allowed provided they are not heavily applied

Study Design

Total Participants: 30
Study Start date:
May 01, 2004
Estimated Completion Date:
July 31, 2007

Study 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.

Connect with a study center

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Providence Hospital

    Washington, District of Columbia 20017
    United States

    Site Not Available

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • MBCCOP-Medical College of Georgia Cancer Center

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Rush-Copley Cancer Care Center

    Aurora, Illinois 60507
    United States

    Site Not Available

  • St. Joseph Medical Center

    Bloomington, Illinois 61701
    United States

    Site Not Available

  • Graham Hospital

    Canton, Illinois 61520
    United States

    Site Not Available

  • Memorial Hospital

    Carthage, Illinois 62321
    United States

    Site Not Available

  • Eureka Community Hospital

    Eureka, Illinois 61530
    United States

    Site Not Available

  • Galesburg Clinic

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Galesburg Cottage Hospital

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Mason District Hospital

    Havana, Illinois 62644
    United States

    Site Not Available

  • Hopedale Medical Complex

    Hopedale, Illinois 61747
    United States

    Site Not Available

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois 60435
    United States

    Site Not Available

  • Kewanee Hospital

    Kewanee, Illinois 61443
    United States

    Site Not Available

  • McDonough District Hospital

    Macomb, Illinois 61455
    United States

    Site Not Available

  • BroMenn Regional Medical Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Community Cancer Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Community Hospital of Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois 61554
    United States

    Site Not Available

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Methodist Medical Center of Illinois

    Peoria, Illinois 61636
    United States

    Site Not Available

  • OSF St. Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Proctor Hospital

    Peoria, Illinois 61614
    United States

    Site Not Available

  • Illinois Valley Community Hospital

    Peru, Illinois 61354
    United States

    Site Not Available

  • Perry Memorial Hospital

    Princeton, Illinois 61356
    United States

    Site Not Available

  • St. Margaret's Hospital

    Spring Valley, Illinois 61362
    United States

    Site Not Available

  • CCOP - Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Site Not Available

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana 46107
    United States

    Site Not Available

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana 46360
    United States

    Site Not Available

  • Reid Hospital & Health Care Services, Incorporated

    Richmond, Indiana 47374
    United States

    Site Not Available

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • St. Luke's Hospital

    Cedar Rapids, Iowa 52402
    United States

    Site Not Available

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa 50316-2301
    United States

    Site Not Available

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Mercy Capitol Hospital

    Des Moines, Iowa 50307
    United States

    Site Not Available

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Siouxland Hematology-Oncology Associates

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • Siouxland Regional Cancer Center

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • St. Luke's Regional Medical Center

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates - West Des Moines

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - Chanute

    Chanute, Kansas 66720
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas 67801
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - El Dorado

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - Kingman

    Kingman, Kansas 67068
    United States

    Site Not Available

  • Southwest Medical Center

    Liberal, Kansas 67901
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - Newton

    Newton, Kansas 67114
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - Parsons

    Parsons, Kansas 67357
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - Pratt

    Pratt, Kansas 67124
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - Salina

    Salina, Kansas 67042
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - Wellington

    Wellington, Kansas 67152
    United States

    Site Not Available

  • Associates in Womens Health, P.A. - North Review

    Wichita, Kansas 67203
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - Medical Arts Tower

    Wichita, Kansas 67208
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - Winfield

    Winfield, Kansas 67156
    United States

    Site Not Available

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan 49221
    United States

    Site Not Available

  • Haematology-Oncology Associates of Ohio and Michigan, P.C.

    Lambertville, Michigan 48144
    United States

    Site Not Available

  • Community Cancer Center of Monroe

    Monroe, Michigan 48162
    United States

    Site Not Available

  • Mercy Memorial Hospital System

    Monroe, Michigan 48162
    United States

    Site Not Available

  • Alexandria, Minnesota 56308
    United States

    Site Not Available

  • Brainerd Medical Center

    Brainerd, Minnesota 56401
    United States

    Site Not Available

  • St. Joseph's Medical Center

    Brainerd, Minnesota 56401
    United States

    Site Not Available

  • Fairview Ridges Hospital

    Burnsville, Minnesota 55337
    United States

    Site Not Available

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota 55433
    United States

    Site Not Available

  • CCOP - Duluth

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Miller-Dwan Medical Center

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Fairview Southdale Hospital

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Fergus Falls, Minnesota 56537
    United States

    Site Not Available

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Hutchinson Area Health Care

    Hutchinson, Minnesota 55350
    United States

    Site Not Available

  • Meeker County Memorial Hospital

    Lichfield, Minnesota 55355
    United States

    Site Not Available

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota 55109
    United States

    Site Not Available

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Chippewa County - Montevideo Hospital

    Montevideo, Minnesota 56265
    United States

    Site Not Available

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota 55422-2900
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Coborn Cancer Center

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Saint Francis Cancer Center

    Shakopee, Minnesota 55379
    United States

    Site Not Available

  • St. Joseph's Hospital

    St Paul, Minnesota 55102
    United States

    Site Not Available

  • CentraCare Clinic - River Campus

    St. Cloud, Minnesota 56303
    United States

    Site Not Available

  • Park Nicollet Health Services

    St. Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Regions Hospital Cancer Care Center

    St. Paul, Minnesota 55101
    United States

    Site Not Available

  • United Hospital

    St. Paul, Minnesota 55102
    United States

    Site Not Available

  • Ridgeview Medical Center

    Waconia, Minnesota 55387
    United States

    Site Not Available

  • Woodwinds Health Campus

    Woodbury, Minnesota 55125
    United States

    Site Not Available

  • CCOP - Montana Cancer Consortium

    Billings, Montana 59101
    United States

    Site Not Available

  • Deaconess Billings Clinic - Downtown

    Billings, Montana 59107-7000
    United States

    Site Not Available

  • Deaconess Billings Clinic Cancer Center

    Billings, Montana 59107-5100
    United States

    Site Not Available

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana 59101
    United States

    Site Not Available

  • Northern Rockies Radiation Oncology Center

    Billings, Montana 59101
    United States

    Site Not Available

  • St. Vincent Healthcare

    Billings, Montana 59101
    United States

    Site Not Available

  • Bozeman Deaconess Hospital

    Bozeman, Montana 59715
    United States

    Site Not Available

  • Internal Medicine Associates of Bozeman

    Bozeman, Montana 59715
    United States

    Site Not Available

  • St. James Community Hospital

    Butte, Montana 59701
    United States

    Site Not Available

  • Sletten Regional Cancer Institute

    Great Falls, Montana 59405
    United States

    Site Not Available

  • St. Peter's Hospital

    Helena, Montana 59601
    United States

    Site Not Available

  • Glacier Oncology, PLLC

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Kalispell Medical Oncology

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Kalispell Regional Medical Center

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Eastern Montana Cancer Center

    Miles City, Montana 59301
    United States

    Site Not Available

  • Community Medical Center

    Missoula, Montana 59801
    United States

    Site Not Available

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana 59807
    United States

    Site Not Available

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana 59807-7877
    United States

    Site Not Available

  • Rutherford Hospital

    Rutherfordton, North Carolina 28139
    United States

    Site Not Available

  • Bismarck Cancer Center

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Cancer Care Center at Medcenter One Hospital

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Mid Dakota Clinic, P. C.

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • St. Alexius Medical Center

    Bismarck, North Dakota 58502
    United States

    Site Not Available

  • Wood County Oncology Center

    Bowling Green, Ohio 43402
    United States

    Site Not Available

  • CCOP - Dayton

    Dayton, Ohio 45429
    United States

    Site Not Available

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio 45409
    United States

    Site Not Available

  • Good Samaritan Hospital

    Dayton, Ohio 45406
    United States

    Site Not Available

  • Grandview Hospital

    Dayton, Ohio 45405
    United States

    Site Not Available

  • Samaritan North Cancer Care Center

    Dayton, Ohio 45415
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio 45428
    United States

    Site Not Available

  • Blanchard Valley Medical Associates

    Findlay, Ohio 45840
    United States

    Site Not Available

  • Fremont Memorial Hospital

    Fremont, Ohio 43420
    United States

    Site Not Available

  • Kenton Oncology, Incorporated

    Kenton, Ohio 43326
    United States

    Site Not Available

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio 45429
    United States

    Site Not Available

  • Lima Memorial Hospital

    Lima, Ohio 45804
    United States

    Site Not Available

  • Northwest Ohio Oncology Center

    Maumee, Ohio 43537
    United States

    Site Not Available

  • St. Luke's Hospital

    Maumee, Ohio 43537
    United States

    Site Not Available

  • Middletown Regional Hospital

    Middletown, Ohio 45044
    United States

    Site Not Available

  • St. Charles Mercy Hospital

    Oregon, Ohio 43616
    United States

    Site Not Available

  • Toledo Clinic - Oregon

    Oregon, Ohio 43616
    United States

    Site Not Available

  • Firelands Regional Medical Center

    Sandusky, Ohio 44870
    United States

    Site Not Available

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio 44870
    United States

    Site Not Available

  • Promedica Cancer Center at Flower Hospital

    Sylvania, Ohio 43560
    United States

    Site Not Available

  • Mercy Hospital of Tiffin

    Tiffin, Ohio 44883
    United States

    Site Not Available

  • CCOP - Toledo Community Hospital

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Medical University of Ohio Cancer Center

    Toledo, Ohio 43614
    United States

    Site Not Available

  • St. Vincent Mercy Medical Center

    Toledo, Ohio 43608
    United States

    Site Not Available

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Toledo Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Toledo Surgical Specialists

    Toledo, Ohio 43623
    United States

    Site Not Available

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio 45373-1300
    United States

    Site Not Available

  • Fulton County Health Center

    Wauseon, Ohio 43567
    United States

    Site Not Available

  • United States Air Force Medical Center Wright-Patterson

    Wright-Patterson Afb, Ohio 45433-5529
    United States

    Site Not Available

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio 45385
    United States

    Site Not Available

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota 57117-5039
    United States

    Site Not Available

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming 82801
    United States

    Site Not Available

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