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

Not Applicable

Completed

• Conditions: Weight
• Interventions: Behavioral: Diet and exercise

• Registration Number: NCT02037542
• Lead Sponsor: Baptist Health South Florida

Brief Summary

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.

Detailed Description

* 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.

Study Timeline

• Study First Submitted: 2013-07-16
• Study Start: 2013-09
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• DCIS
• Women with stage 0 - III breast cancer (histologic type ductal or lobular)
• BMI >=25
• Patients must have completed all chemotherapy
• Patients may be on hormonal therapy or radiation therapy
• Age >= 18 years old to 89 Years old
• Patient must be medically stable and without significant impairments that would preclude following the proposed intervention regimen.
• Time of diagnosis: patients enrolled are within 1 month to 18 months post-diagnosis.

Exclusion Criteria

• Metastatic breast cancer patients and patients with inoperable or active loco-regional disease.
• Patients following alternative/complementary diets or taking high dose antioxidant supplements.
• Patients with a physical/psychiatric impairment that would seriously impair their physical mobility.
• Patients who are currently suffering from severe nausea, anorexia or other diseases affecting health (e.g. arthritis and multiple sclerosis).
• Patients younger than 18 and older than 89 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diet and Exercise	Diet and exercise	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).

Primary Outcome Measures

Name	Time	Method
Lifestyle intervention	One year	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 Outcome Measures

Name	Time	Method
Lipid Profiles, hemoglobin A1C	1 year	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.

Trial Locations

Locations (1)

South Miami Hospital; 🇺🇸 Miami, Florida, United States