Investigational new drugs · 2010
Methylphenidate in the management of asthenia in breast cancer patients treated with docetaxel: results of a pilot study.
Клиническое исследование II фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Cueva Juan F, Calvo Marcos, Anido Urbano, León Luis, Gallardo Elena, Areses Carmen, Bernárdez Beatriz, Gayoso Lucía, García Jorge, Jesús Lamas María, Curiel Teresa, Vázquez Francisca, Candamio Sonia, Vidal Yolanda, Javier Barón Francisco, López Rafael
Аннотация
BACKGROUND: The objectives of this pilot study were to evaluate the safety and efficacy of the central nervous system stimulant methylphenidate in the management of asthenia in breast cancer patients treated with docetaxel.
PATIENTS AND METHODS: Patients with early breast cancer who presented asthenia >3 on the Visual Analogue Scale (VAS) after the first cycle of docetaxel-based chemotherapy were included. Patients received two additional cycles of chemotherapy, one with methylphenidate (10 mg bid) and the other without methylphenidate. Asthenia was evaluated using VAS and the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale. Distress was assessed using the Hospital Anxiety and Depression Scale (HADS), and quality of life using FACT-F.
RESULTS: Ten patients were included and evaluated for efficacy and safety. Overall, cycles with methylphenidate were better tolerated than those without methylphenidate in terms of asthenia (VAS, p = 0.004; FACT-F, p = 0.027) and quality of life (FACT-F, p = 0.047). No significant differences were observed in terms of distress (HADS, p = 0.297). Six (60%) patients continued with methylphenidate after study end. Main adverse events during study were palpitations and insomnia (30% of patients each).
CONCLUSIONS: This pilot study suggests that methylphenidate may reduce asthenia and improve quality of life in breast cancer patients treated with docetaxel.
PATIENTS AND METHODS: Patients with early breast cancer who presented asthenia >3 on the Visual Analogue Scale (VAS) after the first cycle of docetaxel-based chemotherapy were included. Patients received two additional cycles of chemotherapy, one with methylphenidate (10 mg bid) and the other without methylphenidate. Asthenia was evaluated using VAS and the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale. Distress was assessed using the Hospital Anxiety and Depression Scale (HADS), and quality of life using FACT-F.
RESULTS: Ten patients were included and evaluated for efficacy and safety. Overall, cycles with methylphenidate were better tolerated than those without methylphenidate in terms of asthenia (VAS, p = 0.004; FACT-F, p = 0.027) and quality of life (FACT-F, p = 0.047). No significant differences were observed in terms of distress (HADS, p = 0.297). Six (60%) patients continued with methylphenidate after study end. Main adverse events during study were palpitations and insomnia (30% of patients each).
CONCLUSIONS: This pilot study suggests that methylphenidate may reduce asthenia and improve quality of life in breast cancer patients treated with docetaxel.
Предметные рубрики MeSH
Activities of Daily LivingAdultAgedAntineoplastic Combined Chemotherapy ProtocolsAstheniaBreast NeoplasmsCentral Nervous System StimulantsCross-Over StudiesDocetaxelFemaleHumansMethylphenidateMiddle AgedPilot ProjectsProspective StudiesQuality of LifeSeverity of Illness IndexSpainSurveys and QuestionnairesTaxoidsTime FactorsTreatment Outcome