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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 ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Deaconess Billings Clinic Cancer CenterBillings, Montana  59107
Internal Medicine Associates of BozemanBozeman, Montana  59715
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
Sletten Regional Cancer InstituteGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Eastern Montana Cancer CenterMiles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
MBCCOP-Medical College of Georgia Cancer CenterAugusta, Georgia  30912-4000
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, P.A. - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, P.A. - KingmanKingman, Kansas  67068
Cancer Center of Kansas, P.A. - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - PrattPratt, Kansas  67124
Cancer Center of Kansas, P.A. - SalinaSalina, Kansas  67042
Cancer Center of Kansas, P.A. - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A. - Medical Arts TowerWichita, Kansas  67208
Associates in Womens Health, P.A. - North ReviewWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WinfieldWinfield, Kansas  67156
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Haematology-Oncology Associates of Ohio and Michigan, P.C.Lambertville, Michigan  48144
Community Cancer Center of MonroeMonroe, Michigan  48162
Mercy Memorial Hospital SystemMonroe, Michigan  48162
Alexandria, Minnesota  56308
Brainerd Medical CenterBrainerd, Minnesota  56401
St. Joseph's Medical CenterBrainerd, Minnesota  56401
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Chippewa County - Montevideo HospitalMontevideo, Minnesota  56265
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
Mid Dakota Clinic, P. C.Bismarck, North Dakota  58501
Wood County Oncology CenterBowling Green, Ohio  43402
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Fremont Memorial HospitalFremont, Ohio  43420
Kenton Oncology, IncorporatedKenton, Ohio  43326
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Middletown Regional HospitalMiddletown, Ohio  45044
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Promedica Cancer Center at Flower HospitalSylvania, Ohio  43560
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Toledo Surgical SpecialistsToledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Fulton County Health CenterWauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
Miller-Dwan Medical CenterDuluth, Minnesota  55805
Saint Francis Cancer CenterShakopee, Minnesota  55379
St. Joseph's HospitalSt Paul, Minnesota  55102
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Providence HospitalWashington, District of Columbia  20017
Woodwinds Health CampusWoodbury, Minnesota  55125
United States Air Force Medical Center Wright-PattersonWright-Patterson Afb, Ohio  45433-5529