Phase II randomized, placebo-controlled trial of phytotherapeutic product Catuama for breast cancer women undergoing adjuvant radiation therapy.

医学 安慰剂 乳腺癌 医院焦虑抑郁量表 内科学 随机对照试验 生活质量(医疗保健) 癌症 不利影响 萧条(经济学) 外科 焦虑 精神科 病理 护理部 经济 替代医学 宏观经济学
作者
Felipe Melo Cruz,Daniel de Iracema Gomes Cubero,Patrícia Xavier Santi,Luciana Garcia Landeiro,Andressa Sayuri Tamashiro,Larisse Soares Ribeiro,Auro del Giglio
出处
期刊:Journal of Clinical Oncology [American Society of Clinical Oncology]
卷期号:31 (15_suppl): e20524-e20524
标识
DOI:10.1200/jco.2013.31.15_suppl.e20524
摘要

e20524 Background: Fatigue and Depression are common in patients undergoing Breast Cancer (BC) treatment. Catuama is a registered phytotherapic that contains 4 brazilian herbs per capsule: Trichilia catigua (87.5mg), Ptychopetalum olacoides (87.5mg), Paullinia cupana (125 mg) and Zingiber officinale (10mg). Objectives: Since one of its constituents is Guarana (Paulinia cupana) which we already reported to have anti-fatigue effects, we decided to test Catuama potential anti-fatigue effects in BC women undergoing adjuvant 4 weeks of Radiation Therapy (RxT). Methods: This is a double blinded, randomized, placebo-controlled, Phase II cross-over trial. Patients with histologically proven BC with the indication of adjuvant RxT, non-pregnant nor breastfeeding, older than 18 years of age, with ECOG PS 0 or 1, without a history of cardiac, renal, hepatic or psychiatric decompensation, received Catuama 1 capsule twice daily versus a matching placebo for the first 2 weeks of RxT treatment, followed by a week of wash out, followed by an additional two weeks of treatment with crossover of experimental arms. Patients were evaluated on days 1, 15 and 36 with the Brief Fatigue Inventory (BFI), Hospital Anxiety and Depression Scale (HADS), Quality of Life FACIT-F, FACIT-ES questionnaires, and Chalder Fatigue scale. Results: We enrolled 90 patients with a median age of 53 years (26 – 80). We saw no statistically significant differences of FACIT ES, FACIT F, HADS, Chalder or BFI scores treated with Catuama or Placebo when we considered all included patients. When we selected only patients with a BFI score above 30, Catuama significantly decreased BFI scores as compared to baseline (p<0.0001). We observed one instance of grade 3 hypermagnesemia in the Catuama arm and one patient had hyperglicemia grade 3 both in the Catuama and in the placebo arm. No grade 4 toxicities were seen. Conclusions: Catuama may help selected patients who already start RxT with evidence of fatigue.

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