Breast Cancer WEight Loss Study (BWEL Study)
- Conditions
- Breast Carcinoma
- Registration Number
- NCT02750826
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
This randomized phase III 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.
- Detailed Description
This randomized controlled trial of weight loss interventions in overweight and obese women with early stage breast cancer consists of two arms, please see the arms section for more information. Patients will be randomized 1:1 within stratification factors: menopausal status (premenopausal vs. postmenopausal), hormone receptor status of the tumor (ER and/or PR positive vs. ER and PR negative), and race/ethnicity (African American vs. Hispanic vs. Other). The primary objective of this trial is to compare the effect of the telephone-based intervention versus a health educational control on invasive disease-free survival (IDFS). The total sample size is 3136 patients. Patient follow up for primary and secondary endpoints will continue to a maximum of 10 years, as per the standard protocol for cooperative group adjuvant trials.
The primary and secondary objectives of the study:
Primary objective To compare the effect of a supervised weight loss intervention plus health education materials versus health education materials alone upon invasive disease free survival (IDFS) in overweight (BMI 27-29.9 kg/m2) and obese (BMI ≥30kg/m2) women diagnosed with HER-2 negative, stage II and III breast cancer.
Secondary objectives
1. To determine the relationship between changes in weight and IDFS, and to explore interaction between the level of clinical benefit from weight loss and the intervention.
2. To evaluate the effect of a supervised weight loss intervention upon:
1. Overall survival
2. Distant disease free survival
3. Weight
4. Body composition (as measured by waist and hip circumference)
5. Insulin Resistance Syndrome associated conditions - diabetes, hospitalization for CV disease
3. To determine the impact of a supervised weight loss intervention on IDFS within subgroups of women with 1) hormone receptor positive breast cancer and 2) hormone receptor negative breast cancer.
4. To determine the impact of a supervised weight loss intervention on IDFS within subgroups of 1) premenopausal women and 2) post-menopausal women.
Patients are to be followed every 6 months for the first 3 years after study enrollment and then annually until 10 years from registration. The intervention will last 2 years or until disease recurrence/progression, new invasive primary cancer as defined in the protocol or patient withdrawal.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 3177
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Invasive disease-free survival Up to 10 years
- Secondary Outcome Measures
Name Time Method Overall survival Up to 10 years Distant disease-free survival Up to 10 years Occurrence of insulin resistance syndrome complications (diabetes, hospitalizations for cardiovascular disease) Up to 10 years Change in weight (defined as % change) At baseline, 6, 12, 24 and 60 months Measures of physical activity (self report and objective) Up to 10 years Dietary intake (total calorie consumption) Up to 10 years Changes in biomarker (insulin) associated with breast cancer risk and outcomes Up to 10 years Changes in biomarker (glucose) associated with breast cancer risk and outcomes Up to 10 years Changes in biomarker (HOMA) associated with breast cancer risk and outcomes Up to 10 years Changes in biomarker (leptin) associated with breast cancer risk and outcomes Up to 10 years Changes in biomarker (adiponectin) associated with breast cancer risk and outcomes Up to 10 years Changes in biomarker (IGF-1) associated with breast cancer risk and outcomes Up to 10 years Changes in biomarker (IGFBP3) associated with breast cancer risk and outcomes Up to 10 years Patient reported outcomes - depression and anxiety Up to 10 years Patient reported outcomes - body image Up to 10 years Patient reported outcomes - incidence of breast cancer treatment related symptoms Up to 10 years Changes in biomarker (IL-6) associated with breast cancer risk and outcomes Up to 10 years Changes in biomarker (CRP) associated with breast cancer risk and outcomes Up to 10 years Changes in biomarker (TNF-a) associated with breast cancer risk and outcomes Up to 10 years Patient reported outcomes - physical functioning Up to 10 years Patient reported outcomes - fatigue Up to 10 years Patient reported outcomes - sleep disturbance Up to 10 years
Related Research Topics
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Trial Locations
- Locations (1489)
Southern Cancer Center PC-Daphne
🇺🇸Daphne, Alabama, United States
Southern Cancer Center PC-Mobile
🇺🇸Mobile, Alabama, United States
Southern Cancer Center PC-Providence
🇺🇸Mobile, Alabama, United States
Southern Cancer Center PC-Springhill
🇺🇸Mobile, Alabama, United States
Anchorage Associates in Radiation Medicine
🇺🇸Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
🇺🇸Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
🇺🇸Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
🇺🇸Anchorage, Alaska, United States
Alaska Women's Cancer Care
🇺🇸Anchorage, Alaska, United States
Anchorage Oncology Centre
🇺🇸Anchorage, Alaska, United States
Scroll for more (1479 remaining)Southern Cancer Center PC-Daphne🇺🇸Daphne, Alabama, United States