Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial
RATIONALE: Lamotrigine may be effective in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether lamotrigine is effective in treating peripheral neuropathy caused by chemotherapy.
PURPOSE: This randomized phase III trial is studying how well lamotrigine works in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy caused by chemotherapy in patients with cancer.
연구 개요
상세 설명
OBJECTIVES:
- Compare the efficacy of lamotrigine vs placebo in reducing pain and symptoms of chemotherapy-induced peripheral neuropathy in patients with cancer.
- Compare symptom distress, mood states, functional abilities, and overall quality of life of patients treated with these agents.
- Determine the toxic effects of lamotrigine in these patients.
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to neurotoxic chemotherapy received (taxanes vs platinum-based compounds vs vinca alkaloids vs combination vs other), status of neurotoxic chemotherapy (actively receiving therapy vs discontinued or completed), and duration of pain or neuropathy symptoms (1-3 months vs 3-6 months vs more than 6 months). Patients are randomized to 1 of 2 treatment arms.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Arizona
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Scottsdale, Arizona, 미국, 85259
- Mayo Clinic Scottsdale
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Florida
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic - Jacksonville
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Georgia
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Atlanta, Georgia, 미국, 30342-1701
- CCOP - Atlanta Regional
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Hawaii
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Honolulu, Hawaii, 미국, 96813
- MBCCOP - Hawaii
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Illinois
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Peoria, Illinois, 미국, 61615-7828
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, 미국, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, 미국, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, 미국, 50309-1854
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, 미국, 51101-1733
- Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
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Kansas
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Wichita, Kansas, 미국, 67214-3882
- CCOP - Wichita
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Michigan
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Ann Arbor, Michigan, 미국, 48106
- CCOP - Michigan Cancer Research Consortium
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Minnesota
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Duluth, Minnesota, 미국, 55805
- CCOP - Duluth
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, 미국, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, 미국, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, 미국, 68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, 미국, 58501-5505
- Cancer Care Center at Medcenter One Hospital
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Ohio
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Dayton, Ohio, 미국, 45429
- CCOP - Dayton
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Toledo, Ohio, 미국, 43623-3456
- CCOP - Toledo Community Hospital
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South Carolina
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Spartanburg, South Carolina, 미국, 29303
- CCOP - Upstate Carolina
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South Dakota
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Rapid City, South Dakota, 미국, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, 미국, 57104
- CCOP - Sioux Community Cancer Consortium
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Wisconsin
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Green Bay, Wisconsin, 미국, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
Received, or are currently receiving, neurotoxic chemotherapy, including any of the following:
- Taxanes (e.g., paclitaxel or docetaxel)
- Platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin)
- Vinca alkaloids (e.g., vincristine or vinblastine)
Experiencing pain or symptoms of peripheral neuropathy for at least 1 month attributed to chemotherapy
- Average daily pain rating of at least 4 out of 10 OR
- Peripheral neuropathy at least grade 1 out of 3 using ECOG sensory neuropathy rating
PATIENT CHARACTERISTICS:
Age
- 18 and over
Life expectancy
- At least 6 months
Hepatic
- Bilirubin < 2 times upper limit of normal (ULN)
Renal
- Creatinine ≤ 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reaction or intolerance to lamotrigine
- No extreme difficulty swallowing pills
No other identified causes of painful paresthesia preceding chemotherapy, including any of the following:
- Radiation or malignant plexopathy
- Lumbar or cervical radiculopathy
Pre-existing peripheral neuropathy of another etiology, such as any of the following:
- Cyanocobalamin deficiency
- AIDS
- Monoclonal gammopathy
- Diabetes
- Heavy metal poisoning amyloidosis
- Syphilis
- Hyperthyroidism or hypothyroidism
- Inherited neuropathy
- No significant psychiatric illness (e.g., mania, psychosis, or schizophrenia) that would preclude study participation
- Able to complete questionnaires
PRIOR CONCURRENT THERAPY:
Chemotherapy
- See Disease Characteristics
- More than 7 days since prior methotrexate or other dihydrofolate inhibitors
Other
More than 7 days since prior, and no concurrent use of any of the following:
Tricyclic antidepressants (e.g., amitriptyline, nortriptyline, or desipramine)
- Concurrent selective serotonin reuptake inhibitors allowed
- Monoamine oxidase inhibitors
- Opioid analgesics
- Anticonvulsants (e.g., gabapentin, topiramate, valproic acid, or clonazepam)
Adjuvant analgesics (e.g., mexiletine)
- Prior nonsteroidal anti-inflammatory drugs allowed
- Topical analgesics (e.g., lidocaine gel or patch) to the affected area
- Amifostine
- More than 30 days since prior investigational agents for pain control
- No other concurrent investigational agents for pain control
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Arm I - lamotrigine
Patients receive oral lamotrigine once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks in the absence of unacceptable toxicity. Quality of life, pain, mood states, and symptom distress are assessed at baseline and at 4, 6, 8, and 10 weeks. Patients are followed at 3-7 days. |
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다른: Arm II - placebo
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks in the absence of unacceptable toxicity. Quality of life, pain, mood states, and symptom distress are assessed at baseline and at 4, 6, 8, and 10 weeks. Patients are followed at 3-7 days. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)
기간: From baseline to week 10
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The change in mean score for average daily pain from baseline to week 10 using the Pain Intensity Rating (NRS) are reported below.
The NRS scale ranges from 0 to 10 with higher scores corresponding to having more pain.
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From baseline to week 10
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Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)
기간: From baseline to week 10
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The change in mean score for average daily pain from baseline to week 10 using the European Cooperative Oncology Group (ECOG) neuropathy scale (ENS) are reported below.
The ENS scale goes from 0 to 3 with 0=none, 1=mild paresthesias, 2=mild or moderate sensory loss and/or moderate paresthesias, and 3=severe sensory loss or paresthesias that interfere with function.
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From baseline to week 10
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10
기간: From baseline to week 10
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The change in overall quality of life as measured by the Uniscale QOL (Week 10 minus Baseline) using the Wilcoxon test is reported for each arm below.
The Uniscale is a score that ranges from 0 to 100, with 0 being QOL as bad as it can be and 100 being as good as it can be.
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From baseline to week 10
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Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]
기간: From baseline to week 10
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The average change in Brief Pain Inventory (BPI) Worst Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below.
The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
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From baseline to week 10
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Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]
기간: From baseline to week 10
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The average change in Brief Pain Inventory (BPI) Least Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. Time Frame: Up to 1 week post-treatment |
From baseline to week 10
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Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]
기간: From baseline to week 10
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The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below.
The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
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From baseline to week 10
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Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline]
기간: From baseline to week 10
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The average change in Brief Pain Inventory (BPI) Pain Now scores between baseline and week 10 using Wilcoxon test are reported for each arm below.
The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
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From baseline to week 10
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Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline]
기간: From baseline to week 10
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The average change in Brief Pain Inventory (BPI) Pain Relief scores between baseline and week 10 using Wilcoxon test are reported for each arm below.
The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
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From baseline to week 10
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Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]
기간: From baseline to week 10
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The average change in Brief Pain Inventory (BPI) Pain Interference scores between baseline and week 10 using Wilcoxon test are reported for each arm below.
The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
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From baseline to week 10
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Change in POMS Total Score [Week 10 Minus Baseline]
기간: From baseline to week 10
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The average change in POMS Total scores between baseline and week 10 using Wilcoxon test are reported for each arm below.
The POMS scales are calculated from patient responses on 30 questions asking how they have been feeling during the past week.
The scores are all transformed so that 0 is the worst possible value and 100 is the best possible value.
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From baseline to week 10
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Renno SI, Rao RD, Sloan J, et al.: The efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase III randomized, double blind, placebo-controlled NCCTG trial, N01C3. [Abstract] J Clin Oncol 24 (Suppl 18): A-8530, 475s, 2006.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NCCTG-N01C3
- CDR0000322830 (레지스트리 식별자: PDQ (Physician Data Query))
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