Breast CancerNCT00470119
Effect of a Low-Calorie Diet and/or Exercise Program on Risk Factors for Developing Breast Cancer in Overweight or Obese Postmenopausal Women
A study testing behavioral dietary intervention and Exercise intervention in people with Breast Cancer and Obesity, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese postmenopausal woman's risk of developing breast cancer. It is not yet known whether a low-calorie diet and/or exercise program are more effective than no diet or exercise program in lowering an overweight or obese… Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Obesity, Weight Changes
- What is being tested?
- behavioral dietary intervention and Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 439 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Feb 2010
- 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 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- At increased risk for developing breast cancer due to any of the following lifestyle risk factors:
- Lack of physical activity
- Excess weight
- Obesity
- Weight gain over lifetime
- Body mass index > 25.0
- Physically able to undertake a moderate exercise or calorie reduction program
- No history of invasive or in situ breast cancer
PATIENT CHARACTERISTICS:
- Postmenopausal, defined by the absence of periods for the past 12 months
- Able to attend study clinic visits and classes, and undergo study measurements
- Able to fill out questionnaires and logs in English
- No moderate to high alcohol intake (more than 2 drinks per day)
- No concurrent smoking
- No invasive cancer within the past 10 years except simple basal cell or squamous cell carcinoma
- No diabetes mellitus
- Fasting blood sugar < 126 mg/dL (on 2 occasions)
- Hematocrit 32-48%
- WBC 3,000-15,000/mm³
- Potassium 3.5-5.0 mEq/L
- Creatinine ≤ 2.0 mg/dL
- No abnormalities on screening physical that contraindicate study participation
- No contraindications for treadmill testing or entry into a training program, including any of the following:
- Myocardial infarction within the past 6 months
- Pulmonary edema
- Myocarditis
- Pericarditis
- Unstable angina
- Pulmonary embolism or deep vein thrombosis
- Uncontrolled hypertension (i.e., blood pressure > 200/100 mm Hg)
- Orthostatic hypotension
- Moderate-to-severe aortic stenosis
- Uncontrolled arrhythmia
- Uncontrolled congestive heart failure
- Third-degree heart block
- Left bundle branch block
- Thrombophlebitis
- ST depression > 3 mm at rest
- History of cardiac arrest or stroke
- Normal exercise treadmill testing (ETT)
- Negative thallium or echo ETT required for patients with abnormal ETT (defined as ≥ 1.5 mm ST depression in > 1 lead within 1-minute recovery OR ≥ 1.1 mm ST depression in > 1 lead after 1-minute recovery OR reading of positive test by study doctor)
- No drug abuse
- No significant mental illness
PRIOR CONCURRENT THERAPY:
- More than 6 months since prior and no concurrent menopausal hormone replacement therapy of any type, including vaginal route
- No concurrent participation in any other organized weight loss or exercise program
- No concurrent appetite suppressant medication
- No concurrent medications (e.g., weight-loss medications) likely to interfere with adherence to interventions or study outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
About this study
Official title: Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)
RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese postmenopausal woman's risk of developing breast cancer. It is not yet known whether a low-calorie diet and/or exercise program are more effective than no diet or exercise program in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer.
PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or exercise program on risk factors for developing breast cancer compared with no diet or exercise program in overweight or obese postmenopausal women.
Read the detailed description
OBJECTIVES:
Primary
- Compare the effects of a 1-year exercise intervention, reduced-calorie diet intervention, or a combined exercise and reduced-calorie diet intervention vs no intervention on serum estrone concentrations in overweight or obese postmenopausal women.
Secondary
- Compare the effects of these interventions on serum levels of estradiol and free estradiol in these participants.
- Compare the effects of these interventions on serum levels of testosterone and free testosterone in these participants.
- Compare the effects of these interventions on serum levels of sex hormone binding globulin in these participants.
- Compare the effects of these interventions on serum levels of insulin in these participants.
- Compare the effects of these interventions on serum levels of glucose in these participants.
- Compare the effects of these interventions on serum levels of c-peptide in these participants.
- Compare the effects of these interventions on serum levels of insulin-like growth factor I (IGF-1) in these participants.
- Compare the effects of these interventions on serum levels of insulin-like growth factor binding-protein-3 (IGFBP-3) in these participants.
- Compare the effects of these interventions on serum levels of c-reactive protein (CRP) in these participants.
- Compare the effects of these interventions on serum levels of serum amyloid protein A (SAA) in these participants.
- Compare the effects of these interventions on serum levels of interleukin-6 (IL-6) in these participants.
- Compare the effects of these interventions on serum levels of adiponectin in these participants.
- Compare the effects of these interventions on serum levels of leptin in these participants.
- Compare the effects of these interventions on serum levels of ghrelin in these participants.
- Compare the effects of these interventions on serum levels of Vitamin D in these participants.
- Compare the effects of these interventions on mammographic density in these participants.
- Compare the effects of these interventions on anthropometrics and body composition (i.e., weight, body mass index, total and percentage body fat, and waist and hip circumferences) in these participants.
- Compare the effects of these interventions on quality of life in these participants.
- Compare the effects of these interventions on numbers of leukocytes and neutrophiles in these participants.
- Compare the effects of these interventions on VO2max in these participants.
OUTLINE: This is a randomized study. Participants are stratified according to body mass index (< 30 vs ≥ 30). Participants are randomized to 1 of 4 intervention arms.
- Arm I (exercise program): Participants exercise 3 days per week under the supervision of a physiologist and 2 days per week independently at home, for a total of 5 exercise sessions (at least 45 minutes of moderate-intensity exercise per session) weekly over 12 months.
- Arm II (reduced-calorie diet): Participants meet with a nutritionist individually and in small groups. Participants receive general information about diet and behavior strategies such as self-monitoring, goal-setting, stimulus-control, problem-solving, and relapse-prevention training. Participants learn to set a calorie goal and a fat gram goal and how to achieve the goal calorie reduction. Meetings are held weekly during the first 6 months of the diet program but taper off over the course of the study.
- Arm III (exercise program and reduced-calorie diet): Participants meet with a physiologist and a nutritionist, as in arms I and II, and exercise and diet accordingly.
- Arm IV (control: delayed diet and exercise): Participants receive study materials on healthy diet and exercise at the end of the 12-month study period. In addition, participants are offered 2 months of group exercise training with a study physiologist and 4 group meetings with a nutritionist to learn about weight loss techniques and behavioral principles for achieving weight loss.
All participants undergo testing at baseline and periodically during study. Participants undergo blood collection for evaluation of serum levels of sex and metabolic hormones (e.g., estrone, estradiol, testosterone, free testosterone, and sex hormone binding globulin, radioimmunoassay and other immunoassays. Participants also undergo anthropometrics and body composition measurements and mammographic density assessment.
Participants complete questionnaires at baseline and at 6 and 12 months for assessment of diet and exercise. Quality of life (QOL) is measured at baseline and at 6 and 12 months using the Medical Outcomes Study 36-Item Short Form and the Impact of Weight on QOL questionnaire. Information on health habits, medical history, family history of breast cancer, and reproductive and menstrual history is also collected.
FINAL ACCRUAL: A total of 439 participants (118 in the caloric restriction arm, and 117 in both the CR+Exercise, and exercise only arm; and 87 in control arm) were accrued for this study.
- Conditions
- Breast Cancer, Obesity, Weight Changes
- Being tested
- behavioral dietary intervention, Exercise intervention
- Keywords
- breast cancer, obesity, weight changes
- Medical subject headings
- Breast Neoplasms, Obesity, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral dietary interventionBehavioural
Also called Weight Loss interventions
A group based modification of the DPP and LookAHEAD lifestyle programs with a goal of 10% weight loss
Exercise interventionBehavioural
Facility based and home-based exercise designed to increase moderate-to-vigorous aerobic activity in participants to 45 mins/day 5 days/week
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Caloric Restriction | Other | Nutritionist-delivered weight loss intervention though diet modification with an aim of 10% weightloss over a year long intervention based on the DPP and LookAHEAD interventions. Participants meet with a nutritionist individually and in small groups. Participants receive general information about diet and behavior strategies such as self-monitoring, goal-setting, stimulus-control, problem-solving, and relapse-prevention training. Participants learn to set a calorie goal and a fat gram goal and how to achieve the goal calorie reduction. Meetings are held weekly during the first 6 months of the diet program but taper off over the course of the study. Receives: Behavioral: behavioral dietary intervention |
| Exercise Intervention | Other | Participants exercise 3 days per week under the supervision of a physiologist and 2 days per week independently at home, for a total of 5 exercise sessions (at least 45 minutes of moderate-intensity exercise per session) weekly over 12 months Receives: Behavioral: Exercise intervention |
| Caloric Restriction AND Exercise Intervention | Other | Combined caloric restriction \& exercise intervention Receives: Behavioral: behavioral dietary intervention; Behavioral: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum estrone concentrations as measured by radioimmunoassay
Measured: At baseline and 12 months timepoint
Secondary outcomes (22)
Serum estradiol and free estradiol concentration as measured by radioimmunoassay
Measured: At baseline and 12 months timepoint
Testosterone and free testosterone as measured radioimmunoassay
Measured: At baseline and 12 months timepoint
Serum concentrations of Sex hormone binding globulin measured using immunoassays
Measured: At baseline and 12 months timepoint
Mammographic density measurements (i.e., percentage density and dense area of breast tissue)
Measured: At baseline and 12 months timepoint
Change in weight and body mass index (Anthropometrics)
Measured: At baseline and 12 months timepoint
Total and percentage body fat and body fat distribution (i.e., waist and hip circumferences) as measured by dual x-ray absorptiometry
Measured: At baseline and 12 months timepoint
Quality of life (assessed via questionnaires)
Measured: At baseline and 12 months timepoint
Change in daily caloric intake as measured by Food Frequency Questionnaire
Measured: At baseline and 12 months timepoint
Leukocyte and Neutrophil Counts
Measured: Baseline and 12 month timepoints
Serum concentrations of Insulin as measured radioimmunoassay
Measured: Baseline and 12 months
Serum concentrations of Glucose as measured radioimmunoassay
Measured: Baseline and 12 month timepoints
Serum concentrations of Insulin-like growth factor-1
Measured: Baseline and 12 month timepoints
Serum concentrations of Insulin-like growth-factor binding protein-3
Measured: Baseline and 12-month timepoints
Serum Vitamin D concentrations as measured by radioimmunoassay
Measured: Baseline and 12 month timepoints
Serum ghrelin concentrations as measured by radioimmunoassay
Measured: Baseline and 12 month timepoints
Serum C-reactive Protein (CRP) concentrations as measured by radioimmunoassay
Measured: Baseline and 12 month timepoints
Serum concentrations of Serum Amyloid A (SAA) as measured by radioimmunoassay
Measured: Baseline and 12 month timepoints
Serum interleukin-6 (IL-6) concentrations as measured by radioimmunoassay
Measured: Baseline and 12 month timepoints
Serum adiponectin concentrations as measured by radioimmunoassay
Measured: Baseline and 12 month timepoints
Serum leptin concentrations as measured by radioimmunoassay
Measured: Baseline and 12 month timepoints
Serum androtenedione concentrations as measured by radioimmunoassay
Measured: Baseline and 12 month timepoints
Serum c-peptide concentrations as measured by radioimmunoassay
Measured: Baseline and 12 month timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startDec 2004
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Investigator
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Anne McTiernan, MD, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470119
- Sponsor's protocol ID
- PHS 1960.00
- Other IDs
- U54CA116847, P50CA083636, P30CA015704, FHCRC-PHS-1960.00, FHCRC-1960, CDR0000544634
- Status last verified
- Sep 2012
- First submitted
- 3 May 2007
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duggan C, Tapsoba JD, Shivappa N, Harris HR, Hebert JR, Wang CY, McTiernan A. Changes in Dietary Inflammatory Index Patterns with Weight Loss in Women: A Randomized Controlled Trial. Cancer Prev Res (Phila). 2021 Jan;14(1):85-94. doi: 10.1158/1940-6207.CAPR-20-0181. Epub 2020 Aug 28.
PubMed 32859616Mason C, de Dieu Tapsoba J, Duggan C, Wang CY, Alfano CM, McTiernan A. Eating behaviors and weight loss outcomes in a 12-month randomized trial of diet and/or exercise intervention in postmenopausal women. Int J Behav Nutr Phys Act. 2019 Nov 27;16(1):113. doi: 10.1186/s12966-019-0887-1.
PubMed 31775800Duggan C, Tapsoba Jde D, Wang CY, McTiernan A. Dietary Weight Loss and Exercise Effects on Serum Biomarkers of Angiogenesis in Overweight Postmenopausal Women: A Randomized Controlled Trial. Cancer Res. 2016 Jul 15;76(14):4226-35. doi: 10.1158/0008-5472.CAN-16-0399.
PubMed 27417562Habermann N, Makar KW, Abbenhardt C, Xiao L, Wang CY, Utsugi HK, Alfano CM, Campbell KL, Duggan C, Foster-Schubert KE, Mason CE, Imayama I, Blackburn GL, Potter JD, McTiernan A, Ulrich CM. No effect of caloric restriction or exercise on radiation repair capacity. Med Sci Sports Exerc. 2015 May;47(5):896-904. doi: 10.1249/MSS.0000000000000480.
PubMed 25160845Duggan C, Xiao L, Terry MB, McTiernan A. No effect of weight loss on LINE-1 methylation levels in peripheral blood leukocytes from postmenopausal overweight women. Obesity (Silver Spring). 2014 Sep;22(9):2091-6. doi: 10.1002/oby.20806. Epub 2014 Jun 13.
PubMed 24930817Imayama I, Alfano CM, Mason C, Wang C, Duggan C, Campbell KL, Kong A, Foster-Schubert KE, Blackburn GL, Wang CY, McTiernan A. Weight and metabolic effects of dietary weight loss and exercise interventions in postmenopausal antidepressant medication users and non-users: a randomized controlled trial. Prev Med. 2013 Nov;57(5):525-32. doi: 10.1016/j.ypmed.2013.07.006. Epub 2013 Jul 13.
PubMed 23859929Mason C, Xiao L, Imayama I, Duggan CR, Foster-Schubert KE, Kong A, Campbell KL, Wang CY, Villasenor A, Neuhouser ML, Alfano CM, Blackburn GL, McTiernan A. Influence of diet, exercise, and serum vitamin d on sarcopenia in postmenopausal women. Med Sci Sports Exerc. 2013 Apr;45(4):607-14. doi: 10.1249/MSS.0b013e31827aa3fa.
PubMed 23190588Mason C, Foster-Schubert KE, Imayama I, Xiao L, Kong A, Campbell KL, Duggan CR, Wang CY, Alfano CM, Ulrich CM, Blackburn GL, McTiernan A. History of weight cycling does not impede future weight loss or metabolic improvements in postmenopausal women. Metabolism. 2013 Jan;62(1):127-36. doi: 10.1016/j.metabol.2012.06.012. Epub 2012 Aug 14.
PubMed 22898251Mason C, Foster-Schubert KE, Imayama I, Kong A, Xiao L, Bain C, Campbell KL, Wang CY, Duggan CR, Ulrich CM, Alfano CM, Blackburn GL, McTiernan A. Dietary weight loss and exercise effects on insulin resistance in postmenopausal women. Am J Prev Med. 2011 Oct;41(4):366-75. doi: 10.1016/j.amepre.2011.06.042.
PubMed 21961463Mason C, Xiao L, Imayama I, Duggan CR, Bain C, Foster-Schubert KE, Kong A, Campbell KL, Wang CY, Neuhouser ML, Li L, W Jeffery R, Robien K, Alfano CM, Blackburn GL, McTiernan A. Effects of weight loss on serum vitamin D in postmenopausal women. Am J Clin Nutr. 2011 Jul;94(1):95-103. doi: 10.3945/ajcn.111.015552. Epub 2011 May 25.
PubMed 21613554
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)
- ClinicalTrials.gov ID
- NCT00470119
- Acronym / sponsor ID
- PHS 1960.00
- Conditions
- Breast Cancer, Obesity, Weight Changes
- Keywords
- breast cancer, obesity, weight changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 7 May 2007 (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.
RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese postmenopausal woman's risk of developing breast cancer. It is not yet known whether a low-calorie diet and/or exercise program are more effective than no diet or exercise program in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer.
PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or exercise program on risk factors for developing breast cancer compared with no diet or exercise program in overweight or obese postmenopausal women.
Detailed description
OBJECTIVES:
Primary
- Compare the effects of a 1-year exercise intervention, reduced-calorie diet intervention, or a combined exercise and reduced-calorie diet intervention vs no intervention on serum estrone concentrations in overweight or obese postmenopausal women.
Secondary
- Compare the effects of these interventions on serum levels of estradiol and free estradiol in these participants.
- Compare the effects of these interventions on serum levels of testosterone and free testosterone in these participants.
- Compare the effects of these interventions on serum levels of sex hormone binding globulin in these participants.
- Compare the effects of these interventions on serum levels of insulin in these participants.
- Compare the effects of these interventions on serum levels of glucose in these participants.
- Compare the effects of these interventions on serum levels of c-peptide in these participants.
- Compare the effects of these interventions on serum levels of insulin-like growth factor I (IGF-1) in these participants.
- Compare the effects of these interventions on serum levels of insulin-like growth factor binding-protein-3 (IGFBP-3) in these participants.
- Compare the effects of these interventions on serum levels of c-reactive protein (CRP) in these participants.
- Compare the effects of these interventions on serum levels of serum amyloid protein A (SAA) in these participants.
- Compare the effects of these interventions on serum levels of interleukin-6 (IL-6) in these participants.
- Compare the effects of these interventions on serum levels of adiponectin in these participants.
- Compare the effects of these interventions on serum levels of leptin in these participants.
- Compare the effects of these interventions on serum levels of ghrelin in these participants.
- Compare the effects of these interventions on serum levels of Vitamin D in these participants.
- Compare the effects of these interventions on mammographic density in these participants.
- Compare the effects of these interventions on anthropometrics and body composition (i.e., weight, body mass index, total and percentage body fat, and waist and hip circumferences) in these participants.
- Compare the effects of these interventions on quality of life in these participants.
- Compare the effects of these interventions on numbers of leukocytes and neutrophiles in these participants.
- Compare the effects of these interventions on VO2max in these participants.
OUTLINE: This is a randomized study. Participants are stratified according to body mass index (< 30 vs ≥ 30). Participants are randomized to 1 of 4 intervention arms.
- Arm I (exercise program): Participants exercise 3 days per week under the supervision of a physiologist and 2 days per week independently at home, for a total of 5 exercise sessions (at least 45 minutes of moderate-intensity exercise per session) weekly over 12 months.
- Arm II (reduced-calorie diet): Participants meet with a nutritionist individually and in small groups. Participants receive general information about diet and behavior strategies such as self-monitoring, goal-setting, stimulus-control, problem-solving, and relapse-prevention training. Participants learn to set a calorie goal and a fat gram goal and how to achieve the goal calorie reduction. Meetings are held weekly during the first 6 months of the diet program but taper off over the course of the study.
- Arm III (exercise program and reduced-calorie diet): Participants meet with a physiologist and a nutritionist, as in arms I and II, and exercise and diet accordingly.
- Arm IV (control: delayed diet and exercise): Participants receive study materials on healthy diet and exercise at the end of the 12-month study period. In addition, participants are offered 2 months of group exercise training with a study physiologist and 4 group meetings with a nutritionist to learn about weight loss techniques and behavioral principles for achieving weight loss.
All participants undergo testing at baseline and periodically during study. Participants undergo blood collection for evaluation of serum levels of sex and metabolic hormones (e.g., estrone, estradiol, testosterone, free testosterone, and sex hormone binding globulin, radioimmunoassay and other immunoassays. Participants also undergo anthropometrics and body composition measurements and mammographic density assessment.
Participants complete questionnaires at baseline and at 6 and 12 months for assessment of diet and exercise. Quality of life (QOL) is measured at baseline and at 6 and 12 months using the Medical Outcomes Study 36-Item Short Form and the Impact of Weight on QOL questionnaire. Information on health habits, medical history, family history of breast cancer, and reproductive and menstrual history is also collected.
FINAL ACCRUAL: A total of 439 participants (118 in the caloric restriction arm, and 117 in both the CR+Exercise, and exercise only arm; and 87 in control arm) were accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Caloric Restriction | Other | Behavioral: behavioral dietary interventionNutritionist-delivered weight loss intervention though diet modification with an aim of 10% weightloss over a year long intervention based on the DPP and LookAHEAD interventions. Participants meet with a nutritionist individually and in small groups. Participants receive general information about diet and behavior strategies such as self-monitoring, goal-setting, stimulus-control, problem-solving, and relapse-prevention training. Participants learn to set a calorie goal and a fat gram goal and how to achieve the goal calorie reduction. Meetings are held weekly during the first 6 months of the diet program but taper off over the course of the study. |
| Exercise Intervention | Other | Behavioral: Exercise interventionParticipants exercise 3 days per week under the supervision of a physiologist and 2 days per week independently at home, for a total of 5 exercise sessions (at least 45 minutes of moderate-intensity exercise per session) weekly over 12 months |
| Caloric Restriction AND Exercise Intervention | Other | Behavioral: behavioral dietary intervention, Behavioral: Exercise interventionCombined caloric restriction \& exercise intervention |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| behavioral dietary interventionAlso: Weight Loss interventionsA group based modification of the DPP and LookAHEAD lifestyle programs with a goal of 10% weight loss | Behavioural | Caloric Restriction, Caloric Restriction AND Exercise Intervention |
| Exercise interventionFacility based and home-based exercise designed to increase moderate-to-vigorous aerobic activity in participants to 45 mins/day 5 days/week | Behavioural | Caloric Restriction AND Exercise Intervention, Exercise Intervention |
Primary outcome
Serum estrone concentrations as measured by radioimmunoassay
Time frame: At baseline and 12 months timepoint
22 secondary outcomes
Serum estradiol and free estradiol concentration as measured by radioimmunoassay
Time frame: At baseline and 12 months timepoint
Testosterone and free testosterone as measured radioimmunoassay
Time frame: At baseline and 12 months timepoint
Serum concentrations of Sex hormone binding globulin measured using immunoassays
Time frame: At baseline and 12 months timepoint
Mammographic density measurements (i.e., percentage density and dense area of breast tissue)
Time frame: At baseline and 12 months timepoint
Change in weight and body mass index (Anthropometrics)
Time frame: At baseline and 12 months timepoint
Total and percentage body fat and body fat distribution (i.e., waist and hip circumferences) as measured by dual x-ray absorptiometry
Time frame: At baseline and 12 months timepoint
Quality of life (assessed via questionnaires)
Time frame: At baseline and 12 months timepoint
Change in daily caloric intake as measured by Food Frequency Questionnaire
Time frame: At baseline and 12 months timepoint
Leukocyte and Neutrophil Counts
Time frame: Baseline and 12 month timepoints
Serum concentrations of Insulin as measured radioimmunoassay
Time frame: Baseline and 12 months
Serum concentrations of Glucose as measured radioimmunoassay
Time frame: Baseline and 12 month timepoints
Serum concentrations of Insulin-like growth factor-1
Time frame: Baseline and 12 month timepoints
Serum concentrations of Insulin-like growth-factor binding protein-3
Time frame: Baseline and 12-month timepoints
Serum Vitamin D concentrations as measured by radioimmunoassay
Time frame: Baseline and 12 month timepoints
Serum ghrelin concentrations as measured by radioimmunoassay
Time frame: Baseline and 12 month timepoints
Serum C-reactive Protein (CRP) concentrations as measured by radioimmunoassay
Time frame: Baseline and 12 month timepoints
Serum concentrations of Serum Amyloid A (SAA) as measured by radioimmunoassay
Time frame: Baseline and 12 month timepoints
Serum interleukin-6 (IL-6) concentrations as measured by radioimmunoassay
Time frame: Baseline and 12 month timepoints
Serum adiponectin concentrations as measured by radioimmunoassay
Time frame: Baseline and 12 month timepoints
Serum leptin concentrations as measured by radioimmunoassay
Time frame: Baseline and 12 month timepoints
Serum androtenedione concentrations as measured by radioimmunoassay
Time frame: Baseline and 12 month timepoints
Serum c-peptide concentrations as measured by radioimmunoassay
Time frame: Baseline and 12 month timepoints
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 10 Sep 2012.
- Derived from this study: PubMed 32859616Duggan C, Tapsoba JD, Shivappa N, Harris HR, Hebert JR, Wang CY, McTiernan A. Changes in Dietary Inflammatory Index Patterns with Weight Loss in Women: A Randomized Controlled Trial. Cancer Prev Res (Phila). 2021 Jan;14(1):85-94. doi: 10.1158/1940-6207.CAPR-20-0181. Epub 2020 Aug 28.
- Derived from this study: PubMed 31775800Mason C, de Dieu Tapsoba J, Duggan C, Wang CY, Alfano CM, McTiernan A. Eating behaviors and weight loss outcomes in a 12-month randomized trial of diet and/or exercise intervention in postmenopausal women. Int J Behav Nutr Phys Act. 2019 Nov 27;16(1):113. doi: 10.1186/s12966-019-0887-1.
- Derived from this study: PubMed 27417562Duggan C, Tapsoba Jde D, Wang CY, McTiernan A. Dietary Weight Loss and Exercise Effects on Serum Biomarkers of Angiogenesis in Overweight Postmenopausal Women: A Randomized Controlled Trial. Cancer Res. 2016 Jul 15;76(14):4226-35. doi: 10.1158/0008-5472.CAN-16-0399.
- Derived from this study: PubMed 25160845Habermann N, Makar KW, Abbenhardt C, Xiao L, Wang CY, Utsugi HK, Alfano CM, Campbell KL, Duggan C, Foster-Schubert KE, Mason CE, Imayama I, Blackburn GL, Potter JD, McTiernan A, Ulrich CM. No effect of caloric restriction or exercise on radiation repair capacity. Med Sci Sports Exerc. 2015 May;47(5):896-904. doi: 10.1249/MSS.0000000000000480.
- Derived from this study: PubMed 24930817Duggan C, Xiao L, Terry MB, McTiernan A. No effect of weight loss on LINE-1 methylation levels in peripheral blood leukocytes from postmenopausal overweight women. Obesity (Silver Spring). 2014 Sep;22(9):2091-6. doi: 10.1002/oby.20806. Epub 2014 Jun 13.
- Derived from this study: PubMed 23859929Imayama I, Alfano CM, Mason C, Wang C, Duggan C, Campbell KL, Kong A, Foster-Schubert KE, Blackburn GL, Wang CY, McTiernan A. Weight and metabolic effects of dietary weight loss and exercise interventions in postmenopausal antidepressant medication users and non-users: a randomized controlled trial. Prev Med. 2013 Nov;57(5):525-32. doi: 10.1016/j.ypmed.2013.07.006. Epub 2013 Jul 13.
- Derived from this study: PubMed 23190588Mason C, Xiao L, Imayama I, Duggan CR, Foster-Schubert KE, Kong A, Campbell KL, Wang CY, Villasenor A, Neuhouser ML, Alfano CM, Blackburn GL, McTiernan A. Influence of diet, exercise, and serum vitamin d on sarcopenia in postmenopausal women. Med Sci Sports Exerc. 2013 Apr;45(4):607-14. doi: 10.1249/MSS.0b013e31827aa3fa.
- Derived from this study: PubMed 22898251Mason C, Foster-Schubert KE, Imayama I, Xiao L, Kong A, Campbell KL, Duggan CR, Wang CY, Alfano CM, Ulrich CM, Blackburn GL, McTiernan A. History of weight cycling does not impede future weight loss or metabolic improvements in postmenopausal women. Metabolism. 2013 Jan;62(1):127-36. doi: 10.1016/j.metabol.2012.06.012. Epub 2012 Aug 14.
- Derived from this study: PubMed 21961463Mason C, Foster-Schubert KE, Imayama I, Kong A, Xiao L, Bain C, Campbell KL, Wang CY, Duggan CR, Ulrich CM, Alfano CM, Blackburn GL, McTiernan A. Dietary weight loss and exercise effects on insulin resistance in postmenopausal women. Am J Prev Med. 2011 Oct;41(4):366-75. doi: 10.1016/j.amepre.2011.06.042.
- Derived from this study: PubMed 21613554Mason C, Xiao L, Imayama I, Duggan CR, Bain C, Foster-Schubert KE, Kong A, Campbell KL, Wang CY, Neuhouser ML, Li L, W Jeffery R, Robien K, Alfano CM, Blackburn GL, McTiernan A. Effects of weight loss on serum vitamin D in postmenopausal women. Am J Clin Nutr. 2011 Jul;94(1):95-103. doi: 10.3945/ajcn.111.015552. Epub 2011 May 25.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
Anne McTiernan, MD, PhD principal investigator
Fred Hutchinson 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 behavioral dietary intervention and Exercise intervention in people with Breast Cancer and Obesity, run by Fred Hutchinson Cancer Center 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?
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 10 Sep 2012. 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?
Serum estrone concentrations as measured by radioimmunoassay (time frame: At baseline and 12 months timepoint). 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 NCT00470119, which also lists 10 linked publications.
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 10 Sep 2012.