Breast CancerCHOICENCT01315483
Diet Composition, Weight Control, and Breast Carcinogenesis
A study testing Weight Loss Dietary Pattern in people with Breast Cancer, run by Colorado State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Weight Loss Dietary Pattern
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Cancer Center
Denver, Colorado, 80220
About this study
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Weight Loss Dietary Pattern
- Keywords
- Breast cancer, survivors, weight lose, dietary pattern
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss Dietary PatternOther
Also called Low fat, high carb weight loss diet (Vivace Diet), Low carb, high fat weight loss diet (Ricca Diet)
Diet-physical activity program creating a weekly negative energy balance equivalent to 3500 kcal. Intervention groups receive PA protocol promoting the Physical Activity Guidelines and translated in step recommendations, but one of two diets with divergent dietary patterns (opposing fat and CHO content) that do not overlap >+5% in CHO and fat content. Macronutrient values reflect a 'pattern' or ratio within (LC 3:2 ratio for F:CHO; HC 1:4 ratio for F:CHO ) and between diets (LC:HC 3:1 for fat; LC:HC 1:2 for CHO). Six-week meal plans for five calorie levels available and incorporate educational material, supporting program components (e.g. self monitoring tools) and core competencies reinforcing weight loss behaviors in order to promote high levels of dietary adherence.
| Study group | Role | What they receive |
|---|---|---|
| Low fat, high carb weight loss diet | Experimental | Ornish-like weight loss dietary pattern Receives: Other: Weight Loss Dietary Pattern |
| Low carb, high fat weight loss diet | Experimental | South-Beach-like weight loss diet pattern Receives: Other: Weight Loss Dietary Pattern |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation Markers
C-reactive protein, IL-6, TNF-alpha
Measured: Baseline and montlhly for 6 months
Secondary outcomes (6)
Body Fat Percentage (%)
% Body fat, % lean muscle mass, Resting Metabolic Rate (RMR) using the BODPOD (Volumetric weighing; Life Measurement, Inc.) and Tanita Bioelectrical Impedence (BI)
Measured: Baseline and monthly for 6 months
Waist Hip Ratio
Calculated by measuring and dividing waist and hip circumferences
Measured: Baseline and monthly for 6 months
Weight
Using 1) BODPOD (Life Measurement, Inc.) and 2) Tanita Bioelectrical Impedence Scale
Measured: Baseline and monthly for 6 months
Bioavailable sex steroid hormones
estradiol, estrone, sex hormone binding globulin (SHBG)
Measured: Baseline and monthly for 6 months
Glucose metabolism
glucose, insulin, IGF-1, IGFBP-3, glycated proteins (HbA1c)
Measured: Baseline and monthly for 6 months
Cellular oxidation
8-hydroxy-2-deoxyguanosine, DNA damage sensitivity and repair and 8-isoprostane-F-2-alpha
Measured: Baseline and monthly for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startSep 2008
- Primary completionJan 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry J. Thompson, Colorado State University
- Investigators
- Henry J Thompson, PhD, Principal investigator, Colorado State UniversityScot M Sedlacek, MD, Principal investigator, Rocky Mountain Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315483
- Sponsor's protocol ID
- CA125243
- Acronym
- CHOICE
- Status last verified
- Feb 2013
- First submitted
- 14 Mar 2011
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Thompson HJ, Sedlacek SM, Playdon MC, Wolfe P, McGinley JN, Paul D, Lakoski SG. Weight loss interventions for breast cancer survivors: impact of dietary pattern. PLoS One. 2015 May 26;10(5):e0127366. doi: 10.1371/journal.pone.0127366. eCollection 2015.
PubMed 26010254
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Composition, Weight Control, and Breast Carcinogenesis
- ClinicalTrials.gov ID
- NCT01315483
- Acronym / sponsor ID
- CHOICE / CA125243
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, survivors, weight lose, dietary pattern
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low fat, high carb weight loss diet | Experimental | Other: Weight Loss Dietary PatternOrnish-like weight loss dietary pattern |
| Low carb, high fat weight loss diet | Experimental | Other: Weight Loss Dietary PatternSouth-Beach-like weight loss diet pattern |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight Loss Dietary PatternAlso: Low fat, high carb weight loss diet (Vivace Diet), Low carb, high fat weight loss diet (Ricca Diet)Diet-physical activity program creating a weekly negative energy balance equivalent to 3500 kcal. Intervention groups receive PA protocol promoting the Physical Activity Guidelines and translated in step recommendations, but one of two diets with divergent dietary patterns (opposing fat and CHO content) that do not overlap >+5% in CHO and fat content. Macronutrient values reflect a 'pattern' or ratio within (LC 3:2 ratio for F:CHO; HC 1:4 ratio for F:CHO ) and between diets (LC:HC 3:1 for fat; LC:HC 1:2 for CHO). Six-week meal plans for five calorie levels available and incorporate educational material, supporting program components (e.g. self monitoring tools) and core competencies reinforcing weight loss behaviors in order to promote high levels of dietary adherence. | Other | Low carb, high fat weight loss diet, Low fat, high carb weight loss diet |
Primary outcome
Inflammation Markers
Time frame: Baseline and montlhly for 6 months
C-reactive protein, IL-6, TNF-alpha
6 secondary outcomes
Body Fat Percentage (%)
Time frame: Baseline and monthly for 6 months
Waist Hip Ratio
Time frame: Baseline and monthly for 6 months
Weight
Time frame: Baseline and monthly for 6 months
Bioavailable sex steroid hormones
Time frame: Baseline and monthly for 6 months
Glucose metabolism
Time frame: Baseline and monthly for 6 months
Cellular oxidation
Time frame: Baseline and monthly for 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Derived from this study: PubMed 26010254Thompson HJ, Sedlacek SM, Playdon MC, Wolfe P, McGinley JN, Paul D, Lakoski SG. Weight loss interventions for breast cancer survivors: impact of dietary pattern. PLoS One. 2015 May 26;10(5):e0127366. doi: 10.1371/journal.pone.0127366. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry J Thompson, PhD principal investigator
Colorado State University
Scot M Sedlacek, MD principal investigator
Rocky Mountain Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss Dietary Pattern in people with Breast Cancer, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation Markers (time frame: Baseline and montlhly for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01315483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.