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

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ClinicalTrials.gov Identifier: NCT02037542
Recruitment Status : Completed
First Posted : January 16, 2014
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Michelle Gallas, 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.

Condition or disease Intervention/treatment Phase
Weight Behavioral: Diet and exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer
Study Start Date : September 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Behavioral: Diet and exercise
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.




Primary Outcome Measures :
  1. Lifestyle intervention [ Time Frame: 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 :
  1. Lipid Profiles, hemoglobin A1C [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037542


Locations
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United States, Florida
South Miami Hospital
Miami, Florida, United States, 33143
Sponsors and Collaborators
Baptist Health South Florida
Investigators
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Principal Investigator: Maria Amelia Rodrigues, MD BHSF

Publications:
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Responsible Party: Michelle Gallas, Clinical Research Administrator, Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT02037542     History of Changes
Other Study ID Numbers: 072013
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Michelle Gallas, Baptist Health South Florida:
BMI, Lipid profile
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms