Randomized trial of a lifestyle intervention for women with early-stage breast cancer (BC) receiving adjuvant hormone therapy: Initial results.
Randomized trial of a lifestyle intervention for women with early-stage breast cancer (BC) receiving adjuvant hormone therapy: Initial results.
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对接受辅助激素治疗的早期乳腺癌 (BC) 女性进行生活方式干预的随机试验：初步结果。
DOI：
10.1200/jco.2011.29.15_suppl.512
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发表时间：
2011
期刊：
影响因子：
--
通讯作者：
P. Goodwin
中科院分区：
文献类型：
--
作者：
R. Segal;G. Pond;M. Vallis;M. Dion;K. Pritchard;J. Ligibel;M. Levine;P. Goodwin
512背景：肥胖是早期乳腺癌的不良预后因素。我们进行了一项随机临床试验（RCT），以评估2年，集中交付，基于电话的减肥干预（WLI）相比，邮寄的教育干预（EI）的复发，体重减轻和生活质量的绝经后妇女接受辅助来曲唑。由于失去资金，计划招募的2，150名妇女中有338名被终止。
方法
在加拿大和美国的20个中心，338名患有I-IIIa期BC的女性被随机分配至WLI组（n % 171）或单独EI组（n % 167）。入选标准包括BMI ≥24 kg/m2和明确手术时间<3年。WLI涉及19个电话、邮件和一份参与者手册。通过减少热量和脂肪摄入（500-1000 kcal/天，20%热量脂肪）和增加体力活动（150-200分钟/周），体重减轻目标为基线的10%。
结果
平均年龄和BMI为61岁和31.3 kg/m2。两组之间的基线BMI、辅助化疗和肿瘤特征平衡。87.5%的方案规定的WLI呼叫发生。平均体重变化见表。基线BMI ≥/<30 kg/m2和辅助化疗（是/否）的结果相似。在6个月（+4.1 WLI vs. + 2.1 C，p%0.046）和12个月（+3.9 WLI vs. + 2.7 EI，p%0.33）时，WLI与EI的平均SF 36标准化身体成分评分改善。
结论
一个2年，基于电话的WLI导致显着的体重减轻6，12和18个月在公元前早期。结果与BMI <30或30+以及有或无辅助化疗相似。随访继续评估长期效果。由Novartis Pharmaceuticals Inc.资助。由安大略临床肿瘤学小组赞助。[表：见正文]。
512 Background: Obesity is an adverse prognostic factor in early BC. We conducted a randomized clinical trial (RCT) to evaluate a 2-year, centrally delivered, telephone-based weight loss intervention (WLI) compared to a mailed educational intervention (EI) on recurrence, weight loss and QOL in postmenopausal women receiving adjuvant Letrozole. The trial was terminated after 338 of a planned 2,150 women were enrolled due to loss of funding.
METHODS
338 women with stage I-IIIa BC were randomized to WLI (n%171) or EI alone (n%167) at 20 centers in Canada and USA. Eligibility included BMI ≥24 kg/m2and <3 years of definitive surgery. WLI involved 19 calls, mailings and a participant manual. Weight loss goal was 10% of baseline via reduction of caloric and fat intake (500-1000 kcal/day, 20% calories fat) and increased physical activity (150-200 minutes/week).
RESULTS
Mean age and BMI were 61 years and 31.3 kg/m2. Baseline BMI, adjuvant chemotherapy, and tumor characteristics were balanced between arms. 87.5% of protocol mandated WLI calls took place. Mean weight change is shown in the table. Results were similar for baseline BMI ≥/<30 kg/m2 and adjuvant chemotherapy (yes/no). Mean SF 36 normalized physical component score was improved in WLI vs. EI at 6 (+ 4.1 WLI vs. + 2.1 C, p%0.046) and 12 months (+3.9 WLI vs. + 2.7 EI, p%0.33).
CONCLUSIONS
A 2-year, telephone-based WLI resulted in significant weight loss at 6, 12, and 18 months in early BC. Results were similar with BMI <30 or 30+ and with or without adjuvant chemotherapy. Follow-up continues to evaluate longer term effects. Funded by Novartis Pharmaceuticals Inc. Sponsored by the Ontario Clinical Oncology Group. [Table: see text].