- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00068445
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Arizona
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Scottsdale, Arizona, Vereinigte Staaten, 85259
- Mayo Clinic Scottsdale
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32224
- Mayo Clinic - Jacksonville
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30342-1701
- CCOP - Atlanta Regional
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Hawaii
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Honolulu, Hawaii, Vereinigte Staaten, 96813
- MBCCOP - Hawaii
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Illinois
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Peoria, Illinois, Vereinigte Staaten, 61615-7828
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Vereinigte Staaten, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Vereinigte Staaten, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Vereinigte Staaten, 50309-1854
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Vereinigte Staaten, 51101-1733
- Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
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Kansas
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Wichita, Kansas, Vereinigte Staaten, 67214-3882
- CCOP - Wichita
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48106
- CCOP - Michigan Cancer Research Consortium
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Minnesota
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Duluth, Minnesota, Vereinigte Staaten, 55805
- CCOP - Duluth
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Rochester, Minnesota, Vereinigte Staaten, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Vereinigte Staaten, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Vereinigte Staaten, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, Vereinigte Staaten, 58501-5505
- Cancer Care Center at Medcenter One Hospital
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Ohio
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Dayton, Ohio, Vereinigte Staaten, 45429
- CCOP - Dayton
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Toledo, Ohio, Vereinigte Staaten, 43623-3456
- CCOP - Toledo Community Hospital
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South Carolina
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Spartanburg, South Carolina, Vereinigte Staaten, 29303
- CCOP - Upstate Carolina
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South Dakota
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Rapid City, South Dakota, Vereinigte Staaten, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Vereinigte Staaten, 57104
- CCOP - Sioux Community Cancer Consortium
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Wisconsin
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Green Bay, Wisconsin, Vereinigte Staaten, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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. |
|
Sonstiges: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)
Zeitfenster: 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.
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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)
Zeitfenster: 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.
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From baseline to week 10
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10
Zeitfenster: 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
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Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]
Zeitfenster: 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
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Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]
Zeitfenster: 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
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Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]
Zeitfenster: 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.
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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]
Zeitfenster: 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.
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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]
Zeitfenster: 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]
Zeitfenster: 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.
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From baseline to week 10
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Change in POMS Total Score [Week 10 Minus Baseline]
Zeitfenster: 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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Mitarbeiter und Ermittler
Mitarbeiter
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Chemisch induzierte Störungen
- Erkrankungen des Nervensystems
- Neuromuskuläre Erkrankungen
- Vergiftung
- Erkrankungen des peripheren Nervensystems
- Neurotoxizitätssyndrome
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Depressiva des zentralen Nervensystems
- Antipsychotische Mittel
- Beruhigende Agenten
- Psychopharmaka
- Membrantransportmodulatoren
- Antikonvulsiva
- Natriumkanalblocker
- Calciumregulierende Hormone und Wirkstoffe
- Kalziumkanalblocker
- Lamotrigin
Andere Studien-ID-Nummern
- NCCTG-N01C3
- CDR0000322830 (Registrierungskennung: PDQ (Physician Data Query))
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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