Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery
Status: | Completed |
---|---|
Conditions: | Cancer, Chronic Pain |
Therapuetic Areas: | Musculoskeletal, Oncology |
Healthy: | No |
Age Range: | 18 - 120 |
Updated: | 6/29/2016 |
Start Date: | May 2004 |
End Date: | July 2007 |
The Efficacy Of Lidocaine Patch In The Management Of Postsurgical Neuropathic Pain In Patients With Cancer: A Phase III Double-Blind, Crossover Study
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.
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.
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.
- 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.
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
We found this trial at
159
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St. Peter's Hospital Welcome to St. Peter’s Hospital, providing premier health care to a five–county...
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Hutchinson Area Health Care Hutchinson Health is a team of medical professionals and support staff...
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Glacier Oncology, PLLC Glacier Oncology are physician clinics focusing exclusively on the medical subspecialties of...
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Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
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Cancer Center of Kansas, PA - Kingman Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Lima Memorial Hospital We also offer an extended network of primary care, pediatric and specialist...
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McDonough District Hospital McDonough District Hospital is centered in Macomb, Illinois, home to Division 1...
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1575 Beam Avenue
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
651-232-7970
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HealthEast Cancer Care at St. John's Hospital From the moment patients and visitors walk into...
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Northwest Ohio Oncology Center The Northwest Ohio Oncology Center, located on the campus of ProMedica...
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Saint Anthony Memorial Health Centers Franciscan St. Anthony Health - Michigan City is proud to...
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800 E 28th St
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
612-863-4000
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Virginia Piper Cancer Institute at Abbott - Northwestern Hospital As the largest hospital in the...
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701 Park Ave
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
(612) 873-3000
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Hennepin County Medical Center - Minneapolis Hennepin Healthcare System, Inc. operates Hennepin County Medical Center...
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Montana Cancer Center at St. Patrick Hospital and Health Sciences Center St. Patrick Hospital is...
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Community Cancer Center of Monroe The Monroe Cancer Center, a joint venture between the Barbara...
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Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
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BroMenn Regional Medical Center Advocate BroMenn Medical Center is a general medical and surgical hospital...
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Community Hospital of Ottawa Ottawa Regional Hospital, an acute care medical facility, is located on...
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Cancer Center of Kansas, PA - Parsons Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Cancer Treatment Center at Pekin Hospital Since 1913, Pekin Hospital has been dedicated to improving...
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