Clinical Trial TitleA randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer.
National Clinical Trial Number:NCT02750826
Clinical Trial Protocol Description:
This study is accepting patients at both Rush University Medical Center and Rush Copley Medical Center. Please see contact information below to join the study at one location.
This trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are a women, 18 years or older, with documented histologically-confirmed invasive breast cancer, HER2- with no evidence of metastatic disease.
- Have a BMI >/= 27 and are not participating in any other weight loss, diet, or physical activity trial.
- Have had all adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of one or more of the following:
- Diabetes treated with insulin or sulfonylureas.
- Digestive problems (e.g. irritable bowel, diarrhea).
- Cardiovascular, respiratory, or joint issues that would limit moderate physical activity.
- Are not able to walk at least 2 blocks (at any pace) prior to enrollment.
This is a partial list of inclusion and exclusion criteria.