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Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery
This study has been completed.
First Received: April 7, 2003   Last Updated: November 24, 2009   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00058357
  Purpose

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.


Condition Intervention Phase
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Drug: lidocaine
Phase III

Study Type: Interventional
Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title: The Efficacy Of Lidocaine Patch In The Management Of Postsurgical Neuropathic Pain In Patients With Cancer: A Phase III Double-Blind, Crossover Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pain intensity rating (NRS)

Secondary Outcome Measures:
  • 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
  • Incidence of each toxicity reported in each treatment period
  • Maximum severity reported of each toxicity
  • Distribution of the overall toxicity score
  • Proportion of patients who report a preference for lidocaine patch or placebo at study completion
  • Proportion of patients who terminate treatment prematurely

Estimated Enrollment: 100
Study Start Date: May 2004
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058357

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, District of Columbia
Providence Hospital
Washington, District of Columbia, United States, 20017
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Mason District Hospital
Havana, Illinois, United States, 62644
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Proctor Hospital
Peoria, Illinois, United States, 61614
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
United States, Indiana
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States, 47374
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
St. Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States, 51101
United States, Kansas
Associates in Womens Health, P.A. - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, P.A. - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, P.A. - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, P.A. - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, P.A. - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, P.A. - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, P.A. - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, P.A. - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A. - Winfield
Winfield, Kansas, United States, 67156
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
CCOP - Wichita
Wichita, Kansas, United States, 67214
Southwest Medical Center
Liberal, Kansas, United States, 67901
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Michigan
Mercy Memorial Hospital System
Monroe, Michigan, United States, 48162
Haematology-Oncology Associates of Ohio and Michigan, P.C.
Lambertville, Michigan, United States, 48144
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
United States, Minnesota
Brainerd Medical Center
Brainerd, Minnesota, United States, 56401
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422-2900
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
CentraCare Clinic - River Campus
St. Cloud, Minnesota, United States, 56303
Chippewa County - Montevideo Hospital
Montevideo, Minnesota, United States, 56265
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Saint Francis Cancer Center
Shakopee, Minnesota, United States, 55379
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
St. Joseph's Hospital
St Paul, Minnesota, United States, 55102
St. Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
United Hospital
St. Paul, Minnesota, United States, 55102
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Fergus Falls, Minnesota, United States, 56537
Alexandria, Minnesota, United States, 56308
Alexandria, Minnesota, United States, 56308
Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
United States, Montana
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Community Medical Center
Missoula, Montana, United States, 59801
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Deaconess Billings Clinic Cancer Center
Billings, Montana, United States, 59107-5100
Eastern Montana Cancer Center
Miles City, Montana, United States, 59301
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Internal Medicine Associates of Bozeman
Bozeman, Montana, United States, 59715
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Sletten Regional Cancer Institute
Great Falls, Montana, United States, 59405
St. James Community Hospital
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare
Billings, Montana, United States, 59101
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, P. C.
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center
Bismarck, North Dakota, United States, 58502
United States, Ohio
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
CCOP - Dayton
Dayton, Ohio, United States, 45429
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Promedica Cancer Center at Flower Hospital
Sylvania, Ohio, United States, 43560
Grandview Hospital
Dayton, Ohio, United States, 45405
Kenton Oncology, Incorporated
Kenton, Ohio, United States, 43326
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
St. Luke's Hospital
Maumee, Ohio, United States, 43537
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
United States Air Force Medical Center Wright-Patterson
Wright-Patterson AFB, Ohio, United States, 45433-5529
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
Toledo Surgical Specialists
Toledo, Ohio, United States, 43623
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States, 29621
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
Investigator: James D. Bearden, MD Palmetto Hematology Oncology, PC at Gibbs Regional Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000288824, NCCTG-N01CB
Study First Received: April 7, 2003
Last Updated: November 24, 2009
ClinicalTrials.gov Identifier: NCT00058357     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
pain

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Lidocaine
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on November 27, 2009