Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery - Full Text View

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:	Allocation: Randomized Control: Placebo Control Masking: Double-Blind Primary Purpose: Supportive Care
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:

MedlinePlus related topics: Cancer Surgery

Drug Information available for: Lidocaine

U.S. FDA Resources

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

Show 159 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Cheville AL, Sloan JA, Northfelt DW, Jillella AP, Wong GY, Bearden Iii JD, Liu H, Schaefer PL, Marchello BT, Christensen BJ, Loprinzi CL. Use of a lidocaine patch in the management of postsurgical neuropathic pain in patients with cancer: a phase III double-blind crossover study (N01CB). Support Care Cancer. 2009 Apr;17(4):451-60. Epub 2009 Jan 13.

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 March 18, 2010