A Phase III Randomized, Trial of Gabapentin Alone or in Conjunction With an Antidepressant in the Management of Hot Flashes in Women Who Have Inadequate Control With an Antidepressant Alone
gabapentin
+ antidepressant
Maladies du sein+6
+ Néoplasmes du sein
+ Néoplasmes par site
Soins de support
Résumé
Date de début de l'étude : 1 novembre 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: * Compare the efficacy of gabapentin with vs without an antidepressant, as measured by the frequency and intensity of hot flashes, in patients with a history of breast cancer or a concern about taking hormonal therapy due to a fear of developing breast cancer. * Compare adverse events in patients treated with these regimens. * Correlate a reduction in hot flash scores with improvement in quality of life and related outcomes in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to duration of hot flash symptoms (< 9 months vs ≥ 9 months), average frequency of hot flashes per day (2-3 vs 4-9 vs ≥ 10), and antidepressant currently being used (venlafaxine vs paroxetine vs other). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. * Arm II: Patients receive gabapentin as in arm I. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone (per arm I schedule). Patients in both arms complete a hot flash diary at baseline and then daily during study treatment. Quality of life is assessed at baseline and then weekly during study treatment. PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study within 2 years.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.118 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Soins de support
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * History of breast cancer OR a concern about taking hormonal therapy due to a fear of developing breast cancer * Experiencing bothersome hot flashes, defined as patient-reported occurrence ≥ 14 times per week AND sufficiently severe to prompt desire for additional therapeutic intervention despite current use of an antidepressant * Currently (≥ 2 weeks) being treated with a stable dose of an antidepressant * No monoamine oxidase inhibitors or tricyclics * No current evidence of malignant disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Performance status * ECOG 0-1 Life expectancy * At least 6 months Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Chemotherapy * More than 4 weeks since prior antineoplastic chemotherapy * No concurrent antineoplastic chemotherapy Endocrine therapy * More than 4 weeks since prior androgens, estrogens, or progestational agents * More than 2 weeks since prior dehydroepiandrosterone (DHEA) for treatment of hot flashes * No concurrent androgens, estrogens, or progestational agents, including oral contraceptives * No concurrent DHEA for treatment of hot flashes * Concurrent tamoxifen, raloxifene, or aromatase inhibitor therapy allowed if on a stable dose for at least 4 weeks prior to study entry and during study treatment Other * No prior gabapentin * More than 2 weeks since other prior treatment for hot flashes (e.g., clonidine or Bellergal-S®) * Concurrent vitamin E or soy supplements allowed if on a stable dose for at least 1 month prior to study entry and during study treatment * No other concurrent treatment for hot flashes (e.g., clonidine or Bellergal-S®) * No other concurrent antidepressants
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 162 sites
Trinity Medical Center - East
Moline, United StatesBroMenn Regional Medical Center
Normal, United StatesFremont Area Medical Center
Fremont, United States