The Breast Cancer WEight Loss Study (BWEL Study)

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Female
Healthy Volunteers: No
Keywords: Overweight and Obese Women, Early Breast Cancer, Breast Cancer, Overweight and Obese Women with Early Breast Cancer
Type: Other study, Phase 3
Target:
8 Participants
Investigator:
Description
This study is being done to see if losing weight may help prevent breast cancer from coming back.

Studies have found that women who were overweight or obese women when diagnosed with breast cancer have a greater risk of their breast cancer recurring. This is compared to women who were thinner when their cancer was diagnosed.

At this time we do not know whether losing weight will reduce the risk of breast cancer returning. This study will help to show us whether weight loss programs should be a part of breast cancer treatment.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Key Eligibility Criteria:

  • Histologic diagnosis of invasive breast cancer within the past 12 months

  • Her-2 negative

  • Patients must have Stage II or III breast cancer. Eligible TNM stages include

  • ER and PR negative: T2-3N0 or T0-3N1-3 (patients with disease T0N0, T1N0 and T1N1mi disease are not eligible)

  • ER and/or PR positive: T0-3N1-3, or T3N0 (patients with T0N0, T1N0, T2N0 and T1-2N1mi disease are not eligible)

  • All adjuvant or neoadjuvant chemotherapy, radiation and surgery completed at least 21 days prior to registration
  • Participants must be women
  • Age ≥ 18 years
  • ECOG Performance Status 0 or 1
  • No history of other malignancy within past 4 years and no comorbid conditions that would cause life expectancy of less than 5 years (see Section 3.2.6 for complete criteria)
  • No diabetes mellitus currently being treated with insulin or sulfonylurea drugs
  • BMI ≥27 kg/m2 at the time of study enrollment
  • Self-reported ability to walk at least 2 blocks (at any pace)
  • Able to read and comprehend English or Spanish
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will receive the health education program with or without the weight loss program for 2 years. After that, your doctor will continue to watch you for side effects for 8 years as part of your normal breast cancer follow up.
Recruitment period
From March 10, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Breast Carcinoma

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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