Abstract
BackgroundWeight 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/DesignApproximately 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.DiscussionWhile 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 RegistrationCA125243
Highlights
Weight loss in overweight or obese breast cancer patients is associated with an improved prognosis for long term survival
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
Study Design The study, called CHOICE, is a non-randomized, controlled trial in post-menopausal breast cancer survivors investigating whether an energy restricted dietary pattern, i.e. low carbohydrate, high fat or low fat, high carbohydrate, with progressive fat loss during a weight loss program can alter the likelihood of long term survival following treatment for breast cancer as reflected in metabolic and hormonal prognostic biomarkers
Summary
Weight loss in overweight or obese breast cancer patients is associated with an improved prognosis for long term survival. Case control and cohort data is conflicting on fat and carbohydrate intake and breast cancer risk [36,37,38,39,40], with little data available about dietary effects on breast cancer survival [41,42] It is not known whether improvement in biomarkers is progressive with increasing weight loss. This could result in very different clinical guidance related to weight loss in these women
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