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
1秒前
fdpb发布了新的文献求助10
2秒前
5秒前
一个可爱的人完成签到 ,获得积分10
5秒前
向雅完成签到,获得积分10
6秒前
9秒前
Cat完成签到,获得积分0
10秒前
湖里发布了新的文献求助10
11秒前
ZhengYingqi发布了新的文献求助10
15秒前
15秒前
li完成签到 ,获得积分10
15秒前
支初晴完成签到 ,获得积分10
17秒前
17秒前
小小铱完成签到,获得积分10
17秒前
HAHA磾发布了新的文献求助10
19秒前
雪花发布了新的文献求助10
21秒前
月亮完成签到 ,获得积分10
23秒前
RmX完成签到,获得积分10
25秒前
Monologue完成签到 ,获得积分10
28秒前
差生文具多完成签到,获得积分10
29秒前
受伤的老头完成签到,获得积分10
32秒前
Allen完成签到,获得积分10
32秒前
打打应助dushicheng采纳,获得10
33秒前
36秒前
37秒前
37秒前
37秒前
共享精神应助湖里采纳,获得10
39秒前
iu发布了新的文献求助10
40秒前
务实的紫伊完成签到,获得积分10
40秒前
兰贵人发布了新的文献求助10
41秒前
CipherSage应助serayu123采纳,获得10
42秒前
丘比特应助干净含烟采纳,获得10
44秒前
Lucas应助晾猫人采纳,获得10
44秒前
prayme4完成签到,获得积分10
46秒前
wanci应助无情人达采纳,获得30
46秒前
唐瑾瑜完成签到,获得积分10
49秒前
sora98完成签到 ,获得积分10
49秒前
49秒前
50秒前
高分求助中
Spray / Wall-interaction Modelling by Dimensionless Data Analysis 2000
ALA生合成不全マウスでの糖代謝異常の分子機構解析 520
安全防范技术与工程 500
Mathematics and Finite Element Discretizations of Incompressible Navier—Stokes Flows 500
2-Acetyl-1-pyrroline: an important aroma component of cooked rice 500
A real-time energy management strategy based on fuzzy control and ECMS for PHEVs 400
2024 Medicinal Chemistry Reviews 400
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 3190618
求助须知:如何正确求助?哪些是违规求助? 2839902
关于积分的说明 8025837
捐赠科研通 2502907
什么是DOI,文献DOI怎么找? 1336666
科研通“疑难数据库(出版商)”最低求助积分说明 637915
邀请新用户注册赠送积分活动 606166