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The Efficacy Of Lidocaine Patch In The Management Of Postsurgical Neuropathic Pain In Patients With Cancer: A Phase III Double-Blind, Crossover Study


Phase 3
18 Years
N/A
Not Enrolling
Both
Pain, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

The Efficacy Of Lidocaine Patch In The Management Of Postsurgical Neuropathic Pain In Patients With Cancer: A Phase III Double-Blind, Crossover Study


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Pain intensity rating (NRS)

Outcome Time Frame:

4 and 8 weeks

Safety Issue:

No

Principal Investigator

Charles L. Loprinzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000288824

NCT ID:

NCT00058357

Start Date:

May 2004

Completion Date:

July 2007

Related Keywords:

  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • pain
  • Neuralgia

Name

Location

Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
St. Luke's Regional Medical Center Sioux City, Iowa  51104
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
CCOP - Duluth Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Methodist Medical Center of Illinois Peoria, Illinois  61636
CCOP - Montana Cancer Consortium Billings, Montana  59101
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
St. Vincent Mercy Medical Center Toledo, Ohio  43608
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
St. Mary's - Duluth Clinic Cancer Center Duluth, Minnesota  55805
Siouxland Hematology-Oncology Associates Sioux City, Iowa  51101
Siouxland Regional Cancer Center Sioux City, Iowa  51101-1733
Cancer Center of Kansas, P.A. - El Dorado El Dorado, Kansas  67042
Southwest Medical Center Liberal, Kansas  67901
Cancer Center of Kansas, P.A. - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, P.A. - Wichita Wichita, Kansas  67214
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
Deaconess Billings Clinic Cancer Center Billings, Montana  59107
Internal Medicine Associates of Bozeman Bozeman, Montana  59715
Bozeman Deaconess Hospital Bozeman, Montana  59715
St. James Community Hospital Butte, Montana  59701
Sletten Regional Cancer Institute Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Eastern Montana Cancer Center Miles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
MBCCOP-Medical College of Georgia Cancer Center Augusta, Georgia  30912-4000
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Reid Hospital & Health Care Services, Incorporated Richmond, Indiana  47374
St. Luke's Hospital Cedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Cancer Center of Kansas, P.A. - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas, P.A. - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, P.A. - Newton Newton, Kansas  67114
Cancer Center of Kansas, P.A. - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, P.A. - Salina Salina, Kansas  67042
Cancer Center of Kansas, P.A. - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, P.A. - Medical Arts Tower Wichita, Kansas  67208
Associates in Womens Health, P.A. - North Review Wichita, Kansas  67203
Cancer Center of Kansas, P.A. - Winfield Winfield, Kansas  67156
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
Haematology-Oncology Associates of Ohio and Michigan, P.C. Lambertville, Michigan  48144
Community Cancer Center of Monroe Monroe, Michigan  48162
Mercy Memorial Hospital System Monroe, Michigan  48162
Alexandria, Minnesota  56308
Brainerd Medical Center Brainerd, Minnesota  56401
St. Joseph's Medical Center Brainerd, Minnesota  56401
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Chippewa County - Montevideo Hospital Montevideo, Minnesota  56265
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Cancer Care Center at Medcenter One Hospital Bismarck, North Dakota  58501
Bismarck Cancer Center Bismarck, North Dakota  58501
St. Alexius Medical Center Bismarck, North Dakota  58502
Mid Dakota Clinic, P. C. Bismarck, North Dakota  58501
Wood County Oncology Center Bowling Green, Ohio  43402
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Fremont Memorial Hospital Fremont, Ohio  43420
Kenton Oncology, Incorporated Kenton, Ohio  43326
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Middletown Regional Hospital Middletown, Ohio  45044
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Firelands Regional Medical Center Sandusky, Ohio  44870
Promedica Cancer Center at Flower Hospital Sylvania, Ohio  43560
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
Toledo Surgical Specialists Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Fulton County Health Center Wauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Rose Ramer Cancer Clinic at Anderson Area Medical Center Anderson, South Carolina  29621
Miller-Dwan Medical Center Duluth, Minnesota  55805
Saint Francis Cancer Center Shakopee, Minnesota  55379
St. Joseph's Hospital St Paul, Minnesota  55102
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Providence Hospital Washington, District of Columbia  20017
Woodwinds Health Campus Woodbury, Minnesota  55125
United States Air Force Medical Center Wright-Patterson Wright-Patterson Afb, Ohio  45433-5529