Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery
Pain, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional supportive care trial for Pain focused on measuring unspecified adult solid tumor, protocol specific, pain
Eligibility 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
Sites / Locations
- Mayo Clinic Scottsdale
- Providence Hospital
- Mayo Clinic - Jacksonville
- MBCCOP-Medical College of Georgia Cancer Center
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- Kewanee Hospital
- McDonough District Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services, Incorporated
- St. Luke's Hospital
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates
- Siouxland Regional Cancer Center
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Cancer Center of Kansas, P.A. - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, P.A. - El Dorado
- Cancer Center of Kansas, P.A. - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, P.A. - Newton
- Cancer Center of Kansas, P.A. - Parsons
- Cancer Center of Kansas, P.A. - Pratt
- Cancer Center of Kansas, P.A. - Salina
- Cancer Center of Kansas, P.A. - Wellington
- Associates in Womens Health, P.A. - North Review
- Cancer Center of Kansas, P.A. - Medical Arts Tower
- Cancer Center of Kansas, P.A. - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, P.A. - Winfield
- Hickman Cancer Center at Bixby Medical Center
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
- Community Cancer Center of Monroe
- Mercy Memorial Hospital System
- Brainerd Medical Center
- St. Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- CCOP - Duluth
- Miller-Dwan Medical Center
- St. Mary's - Duluth Clinic Cancer Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- HealthEast Cancer Care at St. John's Hospital
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Chippewa County - Montevideo Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- Mayo Clinic Cancer Center
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- Saint Francis Cancer Center
- St. Joseph's Hospital
- CentraCare Clinic - River Campus
- Park Nicollet Health Services
- Regions Hospital Cancer Care Center
- United Hospital
- Ridgeview Medical Center
- Woodwinds Health Campus
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic Cancer Center
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Hospital
- Internal Medicine Associates of Bozeman
- St. James Community Hospital
- Sletten Regional Cancer Institute
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Eastern Montana Cancer Center
- Community Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Rutherford Hospital
- Bismarck Cancer Center
- Cancer Care Center at Medcenter One Hospital
- Mid Dakota Clinic, P. C.
- St. Alexius Medical Center
- Wood County Oncology Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Fremont Memorial Hospital
- Kenton Oncology, Incorporated
- Charles F. Kettering Memorial Hospital
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Middletown Regional Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care, Incorporated
- Promedica Cancer Center at Flower Hospital
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- Toledo Surgical Specialists
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- United States Air Force Medical Center Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sioux Valley Hospital and University of South Dakota Medical Center
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Lidocaine patch
Placebo patch
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.
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.