Aurora, Illinois 60507

  • Unspecified Adult Solid Tumor, Protocol Specific

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.


Study summary:

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.


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


Study is Available At:


Original ID:

NCCTG-N01CB


NCT ID:

NCT00058357


Secondary ID:

NCCTG-N01CB


Study Acronym:


Brief Title:

Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alliance for Clinical Trials in Oncology


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

Official Name:Charles Loprinzi, MD
Study Chair
Mayo Clinic

Study Dates

Start Date:May 2004
Completion Date:July 2007
Completion Type:Actual
Primary Completion Date:July 2006
Primary Completion Type:Actual
Verification Date:June 2016
Last Changed Date:June 27, 2016
First Received Date:April 7, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:Pain intensity rating (NRS)
Time Frame:4 and 8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of each toxicity reported in each treatment period
Time Frame:8 weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Maximum severity reported of each toxicity
Time Frame:8 weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Distribution of the overall toxicity score
Time Frame:8 weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Proportion of patients who report a preference for lidocaine patch or placebo at study completion
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of patients who terminate treatment prematurely
Time Frame:up to 8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:lidocaine
Arm Name:Lidocaine patch
Intervention Type:Other
Name:placebo
Arm Name:Placebo patch

Study Arms

Study Arm Type:Active Comparator
Arm Name:Lidocaine patch
Description: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.
Study Arm Type:Placebo Comparator
Arm Name:Placebo patch
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Alliance for Clinical Trials in Oncology
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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. doi: 10.1007/s00520-008-0542-x. Epub 2009 Jan 13.
PMID:19142669

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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