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
元谷雪发布了新的文献求助10
刚刚
刚刚
天真香烟完成签到,获得积分10
2秒前
Lucas应助可耐的手机采纳,获得10
4秒前
不配.应助LaVineYoung采纳,获得30
5秒前
6秒前
orixero应助sterne采纳,获得20
7秒前
8秒前
8秒前
9秒前
JamesPei应助quan采纳,获得10
9秒前
Benjamin完成签到,获得积分10
9秒前
清爽绮彤完成签到 ,获得积分10
10秒前
sinber完成签到 ,获得积分10
11秒前
puff完成签到,获得积分10
11秒前
你说发布了新的文献求助10
12秒前
追忆发布了新的文献求助10
14秒前
14秒前
大个应助温暖的数据线采纳,获得100
15秒前
ddbuxiang完成签到,获得积分10
16秒前
16秒前
YUNJIE完成签到,获得积分10
17秒前
18秒前
18秒前
天天快乐应助默默的雁易采纳,获得10
19秒前
19秒前
Lbro发布了新的文献求助20
20秒前
20秒前
文艺的爆米花完成签到,获得积分20
21秒前
zuoyou发布了新的文献求助10
21秒前
chen完成签到,获得积分20
21秒前
21秒前
21秒前
小慧儿发布了新的文献求助10
21秒前
RoyChen发布了新的文献求助10
21秒前
1+1应助社恐的金鱼姬采纳,获得30
22秒前
李健的小迷弟应助叮叮叮采纳,获得10
22秒前
shuigui56发布了新的文献求助10
22秒前
Echo完成签到,获得积分10
22秒前
Painkiller_发布了新的文献求助10
22秒前
高分求助中
Spray / Wall-interaction Modelling by Dimensionless Data Analysis 2000
Mixed-anion Compounds 600
ALA生合成不全マウスでの糖代謝異常の分子機構解析 520
Aspects of Babylonian celestial divination: the lunar eclipse tablets of Enūma Anu Enlil 500
Geochemistry, 2nd Edition 地球化学经典教科书第二版 401
2024 Medicinal Chemistry Reviews 400
Dictionary of socialism 350
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 3199095
求助须知:如何正确求助?哪些是违规求助? 2848000
关于积分的说明 8065901
捐赠科研通 2512793
什么是DOI,文献DOI怎么找? 1344804
科研通“疑难数据库(出版商)”最低求助积分说明 639896
邀请新用户注册赠送积分活动 609663