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.

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
大幅提高文件上传限制,最高150M (2024-4-1)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
华仔应助钮祜禄·新语采纳,获得10
刚刚
keyan123完成签到,获得积分10
刚刚
零听发布了新的文献求助10
1秒前
伶俐寒凝发布了新的文献求助10
1秒前
2秒前
热心易绿完成签到 ,获得积分10
2秒前
4秒前
天天快乐应助xx采纳,获得10
4秒前
xiaodong发布了新的文献求助10
7秒前
7秒前
寒来暑往发布了新的文献求助10
9秒前
wubin69完成签到,获得积分20
10秒前
fcsafc完成签到,获得积分10
13秒前
14秒前
现实的幻露完成签到 ,获得积分10
14秒前
Wu完成签到,获得积分10
21秒前
Wyu应助shihui采纳,获得10
22秒前
领导范儿应助科研通管家采纳,获得10
23秒前
星辰大海应助科研通管家采纳,获得10
23秒前
彭于晏应助科研通管家采纳,获得10
23秒前
科研通AI2S应助科研通管家采纳,获得10
23秒前
杳鸢应助科研通管家采纳,获得10
23秒前
SciGPT应助科研通管家采纳,获得10
23秒前
领导范儿应助科研通管家采纳,获得10
24秒前
良辰应助科研通管家采纳,获得10
24秒前
科研通AI2S应助科研通管家采纳,获得10
24秒前
FashionBoy应助科研通管家采纳,获得10
24秒前
shinysparrow应助科研通管家采纳,获得200
24秒前
完美世界应助科研通管家采纳,获得10
24秒前
24秒前
24秒前
科研通AI2S应助科研通管家采纳,获得10
24秒前
24秒前
轩少的完成签到 ,获得积分10
27秒前
安静的小孙完成签到,获得积分20
29秒前
陈星锦发布了新的文献求助10
30秒前
sciq完成签到,获得积分10
30秒前
默默问芙完成签到,获得积分10
31秒前
orixero应助no_one采纳,获得10
33秒前
所所应助六六采纳,获得10
34秒前
高分求助中
Spray / Wall-interaction Modelling by Dimensionless Data Analysis 2000
Evolution 3rd edition 1500
保险藏宝图 1000
Lire en communiste 1000
Mantiden: Faszinierende Lauerjäger Faszinierende Lauerjäger 700
PraxisRatgeber: Mantiden: Faszinierende Lauerjäger 700
Mathematics and Finite Element Discretizations of Incompressible Navier—Stokes Flows 500
热门求助领域 (近24小时)
化学 医学 生物 材料科学 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3186336
求助须知:如何正确求助?哪些是违规求助? 2836575
关于积分的说明 8010249
捐赠科研通 2498970
什么是DOI,文献DOI怎么找? 1334049
科研通“疑难数据库(出版商)”最低求助积分说明 636981
邀请新用户注册赠送积分活动 604909