Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00058357
First received: April 7, 2003
Last updated: October 16, 2013
Last verified: October 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Pain intensity rating (NRS) [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Incidence of each toxicity reported in each treatment period [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Maximum severity reported of each toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Distribution of the overall toxicity score [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients who report a preference for lidocaine patch or placebo at study completion [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients who terminate treatment prematurely [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2004
Study Completion Date: July 2007
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: lidocaine
Placebo Comparator: 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.

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
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00058357     History of Changes
Other Study ID Numbers: CDR0000288824, NCCTG-N01CB
Study First Received: April 7, 2003
Last Updated: October 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
unspecified adult solid tumor, protocol specific
pain

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014