Diet Composition, Weight Control, and Breast Carcinogenesis
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | September 2008 |
| End Date: | June 2012 |
| Contact: | Henry J Thompson, PhD |
| Email: | henry.thompson@colostate.edu |
| Phone: | 970.219.5345 |
In the United States, overweight (BMI > 25 but < 30 Kg/m2) and obesity (BMI > 30Kg/m2) are
increasing at epidemic rates. A significant association exists between being overweight or
obese and breast cancer recurrence and survival. However, evidence continues to accumulate
indicating that achieving or maintaining a healthy weight for height (Body Mass Index, BMI,
18.5-25Kg/m2) is associated with a reduced risk for breast cancer and with a decrease in
breast cancer associated mortality. Despite this, there is a lack of randomized controlled
trials exploring this association and how the process of fat loss or being successful in
actually reaching a healthy weight for height differentially affects biomarkers for cancer
recurrence.
Many dietary approaches for weight loss are currently available to the public, and each
purports to offer advantages. However, there is little scientific evidence to indicate how
these dietary approaches, some of which vary markedly in the foods that they limit or
exclude, affect biomarkers for breast cancer risk. In particular, it is not know whether
the critical factor in relation to weight and breast cancer is simply weight loss (negative
energy balance), irrespective of the manner in which it is achieved, or if certain dietary
approaches affect breast cancer risk biomarkers more favorably than others. Published data
from our laboratory suggest that dietary pattern does matter, and therefore the goal of this
study is to investigate the effects of two popular weight loss dietary approaches that
differ in the extent to which they limit carbohydrate or fat consumption (with effects on
dietary glycemic load) compared to a usual care group on prognostic markers for cancer
recurrence in postmenopausal breast cancer survivors. The investigators hypothesize that in
addition to the anticipated effects of fat loss on circulating levels of bioavailable sex
steroid hormones, that the effects of excess fat on breast cancer prognosis can be
attributed to three interrelated metabolic processes that affect cancer progression: altered
glucose metabolism, chronic inflammation and excessive cellular oxidation.
This study is designed to answer questions about how a dietary pattern either high or low in
dietary carbohydrate and fat availability and fat loss influence metabolic and hormonal
processes that may affect breast cancer recurrence. The investigators hypothesize that in
addition to the anticipated effects of fat loss on circulating levels of bioavailable sex
steroids, that the effects of excess fat on breast cancer prognosis can be attributed to
three interrelated metabolic processes: altered glucose metabolism (IGF-1, IGFBP-3, glycated
proteins), chronic inflammation (C-reactive protein, IL-6, TNF-alpha) and excessive cellular
oxidation (8-hydroxy-2-deoxyguanosine and 8-isoprostane F-2 alpha).
A 6 month intervention study involving 370 post menopausal women who have been treated for
breast cancer is proposed. Randomized women, stratified by resected stage, systemic adjuvant
therapy and body mass index (> 25 and < 35 Kg/m2), will serve as either a non-intervention
control group or will follow a tailored diet-physical activity program designed to create a
weekly negative energy balance equivalent to 3500 kcal. The intervention groups will receive
the same physical activity protocol, but one of two diets that differ in dietary pattern.
The specific aims are: Aim 1. Does a dietary pattern either high or low in available
carbohydrate and fat alter the pattern of change observed in circulating factors involved in
glucose homeostasis, chronic inflammation, cellular oxidation, and steroid hormone
metabolism during progressive loss of body fat? The investigators will also examine how
observed changes in these circulating factors related to changes indicators of breast cancer
recurrence. Aim 2. Do circulating factors associated with glucose homeostasis, chronic
inflammation, and cellular oxidation display the same pattern of change in response to
progressive fat loss as circulating analytes associated with sex steroid metabolism?
Analytes of interest will be measured monthly throughout the study. Aim 3. Does dietary
glycemic load affect the magnitude or rate of fat loss? Plasma adipokines such as leptin and
adiponectin and plasma ghrelin will be measured to provide biological determinants that may
help explain differences in response.
The work proposed in this application should provide quantitative data about the importance
of the magnitude of fat loss on metabolic and hormonal processes involved in cancer
recurrence and provide guidance about effective dietary approaches that maximize weight loss
benefits on breast cancer prognosis.
Inclusion Criteria:
- Female breast cancer survivors
- Staged, resected breast cancer (> 4-months post radiation treatment, chemotherapy or
surgery)
- Post-menopausal (no menses for > 6 months)
- No evidence of metastatic breast disease
- Willing to follow the diet plan prescribed
- Willing to follow the guidelines for alcohol consumption (no more than 1 standard
alcoholic drink per day where one serving is defined as 12oz beer, 5 oz wine OR 1 oz
hard liquor)
- Willing to maintain or increase current physical activity level
- Willing to wear a pedometer and keep a daily record of steps
- Willing to wear heart rate/ accelerometer device (Actiheart) continuously (24/7) for
one week at the start and end of the study
- Willing to wear a body or swim suit and cap for body composition tests
- Willing to record food intake daily
- Willing to come to RMCC Rose for 11 individual and 5 group sessions over a 6 month
period
- Willing to provide urine and fasting blood samples at 7 visits during the study
- Willing to make the commitment it takes to lose weight for the study
- Must have a Body Mass Index between 25Kg/m2 to 35Kg/m2.
Exclusion Criteria:
- Anticipates having surgery during the next 6 months
- Follows a special diet, e.g. gluten free, casein free, dairy free, vegetarian or
other
- Lost 4 or more pounds during the previous month
- Taking weight loss medications during the study
- Being treated by a physician for diabetes
- Has an eating disorder
- Has digestive problems such as IBS (Irritable Bowel Syndrome), Crohn's or other
- Has had surgery involving constriction or removal of any portion of the
gastrointestinal tract (gastric bypass, lap-band, bowel resection, colostomy etc.
- Diagnosed with hepatitis B, hepatitis C or HIV
- Has electronic devices implanted in their body (pacemaker, vagus nerve stimulator)
- Must not use any tobacco products
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