Effect of a Low-Calorie Diet and/or Exercise Program on Risk Factors for Developing Breast Cancer in Overweight or Obese Postmenopausal Women

NCT00470119 | Completed DMC

• 7 other identifiers: PHS 1960.00U54CA116847P50CA083636P30CA015704FHCRC-PHS-1960.00FHCRC-1960CDR0000544634
• Study Type: interventional
• Target: 439
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Breast Cancer; Obesity; Weight Changes

Keywords

breast cancer; obesity; weight changes

Outcome Measures

Primary Outcomes (1)

• Serum estrone concentrations as measured by radioimmunoassay

  At baseline and 12 months timepoint

Secondary Outcomes (22)

• Serum estradiol and free estradiol concentration as measured by radioimmunoassay

  At baseline and 12 months timepoint

• Testosterone and free testosterone as measured radioimmunoassay

  At baseline and 12 months timepoint

• Serum concentrations of Sex hormone binding globulin measured using immunoassays

  At baseline and 12 months timepoint

• Mammographic density measurements (i.e., percentage density and dense area of breast tissue)

  At baseline and 12 months timepoint

• Change in weight and body mass index (Anthropometrics)

  At baseline and 12 months timepoint

Study Arms (4)

Control

NO INTERVENTION

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.

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

Behavioral: Exercise intervention

Caloric Restriction AND Exercise Intervention

OTHER

Combined caloric restriction \& exercise intervention

Behavioral: behavioral dietary intervention; Behavioral: Exercise intervention

Interventions

behavioral dietary intervention BEHAVIORAL

A group based modification of the DPP and LookAHEAD lifestyle programs with a goal of 10% weight loss

Also known as: Weight Loss interventions

Caloric Restriction; Caloric Restriction AND Exercise Intervention

Exercise intervention BEHAVIORAL

Facility based and home-based exercise designed to increase moderate-to-vigorous aerobic activity in participants to 45 mins/day 5 days/week

Caloric Restriction AND Exercise Intervention; Exercise Intervention

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Related Publications (10)

• 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.

  PMID: 32859616 DERIVED

• Mason 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.

  PMID: 31775800 DERIVED

• Duggan 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.

  PMID: 27417562 DERIVED

• Habermann 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.

  PMID: 25160845 DERIVED

• Duggan 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.

  PMID: 24930817 DERIVED

• Imayama 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.

  PMID: 23859929 DERIVED

• Mason 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.

  PMID: 23190588 DERIVED

• Mason 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.

  PMID: 22898251 DERIVED

• Mason 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.

  PMID: 21961463 DERIVED

• Mason 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.

  PMID: 21613554 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Obesity; Body Weight Changes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne McTiernan, MD, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: December 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: September 10, 2012

Record last verified: 2012-09

Locations

US (1)