Effect of a low fat versus a low carbohydrate weight loss dietary intervention on biomarkers of long term survival in breast cancer patients ('CHOICE'): study protocol

BMC Cancer

Henry J Thompson¹  Zongjian Zhu¹  Weiqin Jiang¹  Elizabeth A Daeninck¹  Mark R Wisthoff¹  John N McGinley¹  Pamela Wolfe²  Mary C Playdon¹  Scot M Sedlacek³ 

[1]Cancer Prevention Laboratory, Colorado State University, Fort Collins, CO, USA

[2]Colorado Biostatistics Consortium, University of Colorado, Denver, CO, USA

[3]Rocky Mountain Cancer Centers, Denver CO, USA

关键词: long term survival;    breast cancer;    weight loss;    low carbohydrate;    low fat;    dietary patterns;    biomarkers;   

Others  :  1080848
DOI  :  10.1186/1471-2407-11-287

 received in 2011-06-16, accepted in 2011-07-06,  发布年份 2011

【 摘 要 】

Background

Weight loss in overweight or obese breast cancer patients is associated with an improved prognosis for long term survival. However, it is not clear whether the macronutrient composition of the chosen weight loss dietary plan imparts further prognostic benefit. A study protocol is presented for a dietary intervention to investigate the effects of weight loss dietary patterns that vary markedly in fat and carbohydrate contents on biomarkers of exposure to metabolic processes that may promote tumorigenesis and that are predictive of long term survival. The study will also determine how much weight must be lost for biomarkers to change in a favorable direction.

Methods/Design

Approximately 370 overweight or obese postmenopausal breast cancer survivors (body mass index: 25.0 to 34.9 kg/m²) will be accrued and assigned to one of two weight loss intervention programs or a non-intervention control group. The dietary intervention is implemented in a free living population to test the two extremes of popular weight loss dietary patterns: a high carbohydrate, low fat diet versus a low carbohydrate, high fat diet. The effects of these dietary patterns on biomarkers for glucose homeostasis, chronic inflammation, cellular oxidation, and steroid sex hormone metabolism will be measured. Participants will attend 3 screening and dietary education visits, and 7 monthly one-on-one dietary counseling and clinical data measurement visits in addition to 5 group visits in the intervention arms. Participants in the control arm will attend two clinical data measurement visits at baseline and 6 months. The primary outcome is high sensitivity C-reactive protein. Secondary outcomes include interleukin-6, tumor necrosis factor-α, insulin-like growth factor-1 (IGF), IGF binding protein-3, 8-isoprostane-F2-alpha, estrone, estradiol, progesterone, sex hormone binding globulin, adiponectin, and leptin.

Discussion

While clinical data indicate that excess weight for height is associated with poor prognosis for long term survival, little attention is paid to weight control in the clinical management of breast cancer. This study will provide information that can be used to answer important patient questions about the effects of dietary pattern and magnitude of weight loss on long term survival following breast cancer treatment.

Clinical Trial Registration

CA125243

【 授权许可】

   
2011 Sedlacek et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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