Diet Composition, Weight Control, and Breast Carcinogenesis
21 Years
N/A
Female
Breast Cancer
Trial Information
Diet Composition, Weight Control, and Breast Carcinogenesis
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Inflammation Markers
Outcome Description:
C-reactive protein, IL-6, TNF-alpha
Outcome Time Frame:
Baseline and montlhly for 6 months
Safety Issue:
No
Principal Investigator
Henry J Thompson, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Colorado State University
Authority:
United States: Federal Government
Study ID:
CA125243
NCT ID:
NCT01315483
Start Date:
September 2008
Completion Date:
June 2012
Related Keywords:
- Breast Cancer
- Breast cancer
- survivors
- weight lose
- dietary pattern
- Breast Neoplasms
Name | Location |
|---|---|
| Rocky Mountain Cancer Center | Denver, Colorado 80218 |
