Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design.

Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design.
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DOI:
10.1038/s41523-017-0040-8
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发表时间:
2017
期刊:
影响因子:
5.9
通讯作者:
Goodwin PJ
Goodwin PJ
中科院分区:
医学2区
文献类型:
--
作者:
Ligibel JA;Barry WT;Alfano C;Hershman DL;Irwin M;Neuhouser M;Thomson CA;Delahanty L;Frank E;Spears P;Paskett ED;Hopkins J;Bernstein V;Stearns V;White J;Hahn O;Hudis C;Winer EP;Wadden TA;Goodwin PJ

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超重是早期乳腺癌女性的不良预后因素,但体重减轻对乳腺癌复发风险和乳腺癌诊断时超重或肥胖女性死亡率的影响尚未得到评估。肿瘤临床试验联盟乳腺癌减肥试验(也称为A011401)正在测试基于电话的减肥计划对3136名体重指数≥27 kg/m2的女性无侵袭性疾病生存率的影响,这些女性最近被诊断为II-III期HER-2阴性乳腺癌。试验的次要结局包括减肥干预对总生存期、体重、体力活动、饮食摄入、合并症发生率、血清生物标志物和患者报告结局的影响。参与者以1:1的比例随机分配到一个为期2年的基于电话的减肥干预组或一个教育对照组。干预措施通过42个电话进行,由达纳-法伯癌症研究所的健康教练提供。电话是由一个干预工作簿,以及一些工具,以帮助促进减肥补充。干预目标包括通过限制热量和增加体力活动来减轻基线体重的10%。这项大规模的研究测试了癌症诊断后有目的的减肥对乳腺癌复发和死亡风险的影响,有可能使减肥计划成为乳腺癌治疗的标准部分。
Excess body weight is a poor prognostic factor in women with early breast cancer, but the effect of weight loss on the risk of breast cancer recurrence and mortality in women who are overweight or obese at the time of breast cancer diagnosis has not been evaluated. The Alliance for Clinical Trials in Oncology Breast Cancer Weight Loss trial, also known as A011401, is testing the impact of a telephone-based weight loss program on invasive disease-free survival in 3136 women with a body mass index ≥27 kg/m2 who have recently been diagnosed with stage II-III, HER-2 negative breast cancer. Secondary outcomes of the trial include the impact of the weight loss intervention on overall survival, body weight, physical activity, dietary intakes, incidence of comorbidities, serum biomarkers and patient reported outcomes. Participants are randomized 1:1 to a 2-year, telephone-based weight loss intervention or to an education control group. The intervention is delivered through 42 telephone calls, delivered by health coaches based at the Dana-Farber Cancer Institute. Calls are supplemented by an intervention workbook, as well as a number of tools to help facilitate weight loss. Intervention goals include loss of 10% of baseline body weight, achieved through caloric restriction and increased physical activity. This large-scale study testing the impact of purposeful weight loss after cancer diagnosis on the risk of breast cancer recurrence and mortality has the potential to make weight loss programs a standard part of breast cancer treatment.
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