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



Status:Completed
Conditions:Breast Cancer, Obesity Weight Loss
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:18 - 89
Updated:7/22/2016
Start Date:September 2013
End Date:May 2016

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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.

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.
We found this trial at
1
site
3100 Southwest 62nd Avenue
Miami, Florida 33143
Principal Investigator: Maria Amelia Rodrigues, MD
Phone: 786-662-8913
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mi
from
Miami, FL
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