Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Obesity

Breast Neoplasms

Overweight

Body Weight

Overnutrition

Nutrition Disorders

Prospective, observational, cohort study, with a proposed start date of May 2013 and proposed end date of June 2018. Our goal is to gather data on a total of 200 patients: 100 patients (study group) will be prospectively enrolled, while data on another 100 patients (control) will be accessed through retrospective data collection. Number of patients to be analyzed will depend on enrollment and patient compliance. We would like to enroll the proposed 100 patients in the first 1-3 years of the study (approximately 30 per year).

Upon enrollment, the patient will be asked to meet with a dietitian to assess the individual patient's current diet and exercise routines. In the first session, the dietitian will provide individual counseling and together with the patient devise weight loss / exercise strategies that fit the patients' lifestyle. Following the initial assessment, patients will embark on a weekly program, with weekly meetings lasting 30min - 1h. Patients will be asked to record meal portions weekly in a Food Log (Appendix B), according to the established goal. At each meeting, the dietitian will review the Food Log with the patient and evaluate progress.

Diet and exercise

Maria Amelia Rodrigues, MD

The purpose of this study is to test the hypothesis that an intervention of lifestyle modification will positively impact women with breast cancer who are overweight and/or obese. To that end, our primary endpoint is to examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.

* Primary endpoint: To examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.
* Secondary endpoint: To assess the impact of such intervention on lipid profiles and hemoglobin A1C. The study group will be compared with a historical control group of patients with early stage breast cancer who are obese or overweight who were not given the intervention
* Secondary endpoint: To examine whether an active intervention program will lead into longstanding lifestyle modification in breast cancer patients with a BMI greater or equal to 25.

A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer

To examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.

To assess the impact of such intervention on lipid profiles and hemoglobin A1C. The study group will be compared with a historical control group of patients with early stage breast cancer who are obese or overweight who were not given the intervention and to examine whether an active intervention program will lead into longstanding lifestyle modification in breast cancer patients with a BMI greater or equal to 25.

Baptist Health South Florida

Clinical Research Administrator

Weight Loss

Breast Diseases

Skin Diseases

Body Weight Changes

Menopause

Other Dietary Supplements

All Drugs and Chemicals

Omega 3 Fatty Acid

Participants will be instructed to follow a diet that is reduced by 500-700 kcal/day below maintenance requirements for 24 weeks or until the individual has reached a BMI of 25kg/m2 (generally 1000-2000 calories/day). Participants will be given one capsule of Omega-3 FA (fatty acids) a day beginning 2 weeks after starting their diet and exercise routine. Omega-3 FA will be increased by 1 capsule/day or every other day until participant is taking 5 capsules per day.Each Amber 4020 Ethyl Ester (EE) 1000 mg omega-3 capsule contains 420 mg of EPA and 210 mg of DHA both as the ethyl esters (380 mg EPA and 190 mg DHA)

Participants will be instructed to exercise and follow a diet that is reduced by 500-700 kcal/day below maintenance requirements for 24 weeks or until the individual has reached a BMI of 25kg/m2 (generally 1000-2000 calories/day). Participants will be given one capsule of placebo a day beginning 2 weeks after starting their diet and exercise routine. Placebo capsule will be increased by 1 capsule/day or every other day until participant is taking 5 capsules per day.

Amber 4020 Ethyl Ester (EE) 1000 mg omega-3 capsule contains 420 mg of EPA and 210 mg of DHA both as the ethyl esters (380 mg EPA and 190 mg DHA)

Omega-3 Fatty Acids

Placebo Capsule

Increasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods.

Diet and Exercise

Carol J. Fabian, M.D.

The purpose of this study is to determine if high dose supplementation with the omega-3 fatty acids EPA and DHA, when added to a weight loss program, is well tolerated in the study population and if there is an increase in the favorable change in blood and tissue breast cancer risk factors when compared to weight loss alone.

Subjects will all participate in a 6-month weight loss intervention. Subjects will be randomized to receive either blinded placebo or omega-3 fatty acids for 6 months.

Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women

Randomized Pilot Trial of Omega-3 Fatty Acids or Placebo in Peri- or Post-Menopausal Women at High Risk for Breast Cancer Undergoing a Weight Loss Intervention

Measured as the number of participants that dropout before diet+intervention period is complete

Based on eligibility criteria, study procedures and participation of subjects the study design will be measured to see if it will practically work with a larger study population

Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers

Measure change in fasting and postprandial blood inflammatory, and risk biomarkers

Measure change in weight in participants during the 6-12 month maintenance phase

Change in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA):arachidonic acid (AA) ratio

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer	NCT02037542	Weight	Diet and exerci...	18 Years - 89 Years	Baptist Health South Florida
Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women	NCT02101970	Breast Cancer	Omega-3 Fatty A... Placebo Capsule Diet and Exerci...	45 Years - 70 Years	University of Kansas Medical Center
A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer	NCT02037542	Weight	Diet and exerci...	18 Years - 89 Years	Baptist Health South Florida

Spots Global Cancer Trial Database for diet and exercise