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Lidocaine Patch in Treating C...

Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery

Last Updated: 2016-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Lidocaine 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.

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

Placebo patch

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Interventions

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lidocaine

Intervention Type DRUG

placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Loprinzi, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Providence Hospital

Washington D.C., District of Columbia, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

MBCCOP-Medical College of Georgia Cancer Center

Augusta, Georgia, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Kewanee Hospital

Kewanee, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

St. Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, United States

Site Status

St. Luke's Hospital

Cedar Rapids, Iowa, United States

Site Status

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

Site Status