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Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

3. dubna 2018 aktualizováno: Alliance for Clinical Trials in Oncology

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

131

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Arizona
      • Scottsdale, Arizona, Spojené státy, 85259
        • Mayo Clinic Scottsdale
    • Florida
      • Jacksonville, Florida, Spojené státy, 32224
        • Mayo Clinic - Jacksonville
    • Georgia
      • Atlanta, Georgia, Spojené státy, 30342-1701
        • CCOP - Atlanta Regional
    • Hawaii
      • Honolulu, Hawaii, Spojené státy, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Peoria, Illinois, Spojené státy, 61615-7828
        • CCOP - Illinois Oncology Research Association
      • Urbana, Illinois, Spojené státy, 61801
        • CCOP - Carle Cancer Center
    • Iowa
      • Cedar Rapids, Iowa, Spojené státy, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, Spojené státy, 50309-1854
        • CCOP - Iowa Oncology Research Association
      • Sioux City, Iowa, Spojené státy, 51101-1733
        • Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
    • Kansas
      • Wichita, Kansas, Spojené státy, 67214-3882
        • CCOP - Wichita
    • Michigan
      • Ann Arbor, Michigan, Spojené státy, 48106
        • CCOP - Michigan Cancer Research Consortium
    • Minnesota
      • Duluth, Minnesota, Spojené státy, 55805
        • CCOP - Duluth
      • Rochester, Minnesota, Spojené státy, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, Spojené státy, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, Spojené státy, 55416
        • CCOP - Metro-Minnesota
    • Nebraska
      • Omaha, Nebraska, Spojené státy, 68106
        • CCOP - Missouri Valley Cancer Consortium
    • North Dakota
      • Bismarck, North Dakota, Spojené státy, 58501-5505
        • Cancer Care Center at Medcenter One Hospital
    • Ohio
      • Dayton, Ohio, Spojené státy, 45429
        • CCOP - Dayton
      • Toledo, Ohio, Spojené státy, 43623-3456
        • CCOP - Toledo Community Hospital
    • South Carolina
      • Spartanburg, South Carolina, Spojené státy, 29303
        • CCOP - Upstate Carolina
    • South Dakota
      • Rapid City, South Dakota, Spojené státy, 57709
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Spojené státy, 57104
        • CCOP - Sioux Community Cancer Consortium
    • Wisconsin
      • Green Bay, Wisconsin, Spojené státy, 54301
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: lamotrigin
Jiný: 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.
Jiný: Placebo

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)
Časové okno: From baseline to week 10
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.
From baseline to week 10
Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)
Časové okno: From baseline to week 10
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.
From baseline to week 10

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10
Časové okno: From baseline to week 10
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.
From baseline to week 10
Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]
Časové okno: From baseline to week 10
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.
From baseline to week 10
Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]
Časové okno: From baseline to week 10

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
Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]
Časové okno: From baseline to week 10
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.
From baseline to week 10
Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline]
Časové okno: From baseline to week 10
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.
From baseline to week 10
Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline]
Časové okno: From baseline to week 10
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.
From baseline to week 10
Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]
Časové okno: From baseline to week 10
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.
From baseline to week 10
Change in POMS Total Score [Week 10 Minus Baseline]
Časové okno: From baseline to week 10
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.
From baseline to week 10

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Alliance for Clinical Trials in Oncology

Spolupracovníci

National Cancer Institute (NCI)

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

  • 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.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. února 2004

Primární dokončení (Aktuální)

1. května 2006

Dokončení studie (Aktuální)

1. listopadu 2013

Termíny zápisu do studia

První předloženo

10. září 2003

První předloženo, které splnilo kritéria kontroly kvality

10. září 2003

První zveřejněno (Odhad)

11. září 2003

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. května 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. dubna 2018

Naposledy ověřeno

1. dubna 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • NCCTG-N01C3
  • CDR0000322830 (Identifikátor registru: PDQ (Physician Data Query))

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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