- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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Arizona
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Scottsdale, Arizona, Yhdysvallat, 85259
- Mayo Clinic Scottsdale
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Florida
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Jacksonville, Florida, Yhdysvallat, 32224
- Mayo Clinic - Jacksonville
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30342-1701
- CCOP - Atlanta Regional
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Hawaii
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Honolulu, Hawaii, Yhdysvallat, 96813
- MBCCOP - Hawaii
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Illinois
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Peoria, Illinois, Yhdysvallat, 61615-7828
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Yhdysvallat, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Yhdysvallat, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Yhdysvallat, 50309-1854
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Yhdysvallat, 51101-1733
- Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
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Kansas
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Wichita, Kansas, Yhdysvallat, 67214-3882
- CCOP - Wichita
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Michigan
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Ann Arbor, Michigan, Yhdysvallat, 48106
- CCOP - Michigan Cancer Research Consortium
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Minnesota
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Duluth, Minnesota, Yhdysvallat, 55805
- CCOP - Duluth
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Rochester, Minnesota, Yhdysvallat, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Yhdysvallat, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Yhdysvallat, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, Yhdysvallat, 68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, Yhdysvallat, 58501-5505
- Cancer Care Center at Medcenter One Hospital
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Ohio
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Dayton, Ohio, Yhdysvallat, 45429
- CCOP - Dayton
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Toledo, Ohio, Yhdysvallat, 43623-3456
- CCOP - Toledo Community Hospital
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South Carolina
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Spartanburg, South Carolina, Yhdysvallat, 29303
- CCOP - Upstate Carolina
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South Dakota
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Rapid City, South Dakota, Yhdysvallat, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Yhdysvallat, 57104
- CCOP - Sioux Community Cancer Consortium
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Wisconsin
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Green Bay, Wisconsin, Yhdysvallat, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: 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. |
|
Muut: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)
Aikaikkuna: 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
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Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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
|
Change in POMS Total Score [Week 10 Minus Baseline]
Aikaikkuna: 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.
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From baseline to week 10
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Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Kemiallisesti aiheutetut häiriöt
- Hermoston sairaudet
- Neuromuskulaariset sairaudet
- Myrkytys
- Ääreishermoston sairaudet
- Neurotoksisuusoireyhtymät
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Keskushermostoa lamaavat aineet
- Antipsykoottiset aineet
- Rauhoittavat aineet
- Psykotrooppiset lääkkeet
- Kalvon kuljetusmodulaattorit
- Antikonvulsantit
- Natriumkanavan salpaajat
- Kalsiumia säätelevät hormonit ja aineet
- Kalsiumkanavan salpaajat
- Lamotrigiini
Muut tutkimustunnusnumerot
- NCCTG-N01C3
- CDR0000322830 (Rekisterin tunniste: PDQ (Physician Data Query))
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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