Phase III Trial to Test Weight Loss as Way to Prevent Breast Cancer Recurrence

Researchers want to know if weight loss after diagnosis can help lower the risk of breast cancer recurrence for women who are overweight
Featured Clinical Trials
October 24, 2016
By: 
Eric Fitzsimmons, Copy Editor and Content Coordinator
Reviewed By: 
Jennifer Ligibel, MD

Researchers are looking for 3,136 women who are overweightinfo-icon and have stageinfo-icon II or III breast cancer for a phase III clinical trialinfo-icon to see if losing weight after diagnosisinfo-icon could help prevent breast cancer from coming back.

The researchers are using the Body Mass Indexinfo-icon scale in the study. The BMI scale is used by health experts to measure body fat based on a person’s height and weight. In order to be eligible for this study, patients must have a BMI of at least 27.

BACKGROUND

Past studies have found there is a higher risk of breast cancer returning in women who are overweight or obeseinfo-icon when they’re diagnosed with breast cancer. A New York Times article has pointed to studies from as far back as the 1970s to as recent as 2014 that have found this greater risk of recurrenceinfo-icon and lower rates of survival for women who are obese or overweight. As more studies have shown a connection between excess weight and recurrence, researchers have been interested to see if losing weight after being diagnosed with breast cancer could lower that risk.   

GOALS

The Breast Cancer Weight Loss (BWEL) study will look at how a coached weight loss program held over the first 2 years after primary treatmentinfo-icon affects invasive disease-free survival for women with early-stage breast cancerinfo-icon. Invasive disease-free survival is how long after the end of treatment a woman goes without any sign of the disease returning. They will also look at the effect of the weight loss program on other factors including

  • Overall survival, or the length of time from diagnosis until death from any cause
  • Distant disease-free survival, or how long after treatment a woman goes without the cancer spreading beyond the breast to other organs
  • Weight
  • Other medical conditions such as diabetes and heart disease
  • Quality of lifeinfo-icon and side effects related to breast cancer treatment
  • Diet and exercise patterns
  • Levels of hormones linked to breast cancer

The goal is to see if weight loss programs should be included as part of breast cancer treatment in the future.

STRUCTURE

Women will be randomly assigned into two groups: one that will participate in the weight loss program, and one that will not. Everyone in the study will get health information that includes mailings with healthy living tips, a 2-year health magazine subscription and invitations to webinars on breast cancer and other health topics.

If you are assigned to the program group, you will take part in a weight loss program involving diet and exercise goals with guidance given over the phone from trained coaches. Parts of the program can be tailored to you.  

The Dana-Farber Cancer Institute has partnered with the FitBit company to provide women in the BWEL study with bracelets to track activity and internet-connected scales to report weight and changes in body fat percentage over time. Dana-Farber has also partnered with Nestle Health Science to provide proteininfo-icon meal replacement shakes for patients who are interested in using them to help control their calorie count. These products will help participants and coaches work toward weight loss goals.

The health education and weight loss programs will go on for the first 2 years that each woman participates in the study. Through the program and for a year beyond, researchers will follow-up with participating women every 6 months. After 3 years the researchers will follow-up once each year until breast cancer recurrence, the diagnosis of a new cancer or the end of the 10 year study period.

ELIGIBILITY

Researchers are looking for women who are over the age of 18 and have a BMI of 27 or higher. Other requirements include:

  • Ability to walk two blocks
  • Cancer is HER2-negative
  • Diagnosis of stage II or III breast cancer within the last year
  • Have completed primary treatment
  • Not participating in other weight loss studies

To enroll in the BWEL study, visit the listing on ClinicalTrials.gov and speak with your healthcare providers.

More In Diet, Nutrition and Exercise

Media: Audio
audio
October 26, 2015
Article August 31, 2015
Additional Related Topics 
LONG-TERM IMPACTS OF BREAST CANCER
Fear of Recurrence