Weight Loss Intervention for Breast Cancer Recurrence Prevention

Recruiting at 1510 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jennifer Ligibel, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Women over 18 with invasive breast cancer diagnosed within the last 14 months, who have completed initial treatments and are overweight (BMI ≥27 kg/m2). Participants must be able to walk two blocks and read English. They should not have had other cancers in the past 4 years, severe diseases that limit life expectancy or activity, or serious digestive issues.

Inclusion Criteria

Your body mass index (BMI) is 27 or higher, as measured within the last 56 days before joining the study.

Able to read and comprehend English

My cancer is not HER2 positive based on specific tests.

Exclusion Criteria

No history of psychiatric disorders that would preclude participation in the study intervention or prevent the patient from giving informed consent

I haven't had any cancer except highly curable types in the last 4 years.

I have not had, nor plan to have, weight-loss surgery in the next 2 years.

Treatment Details

Interventions

• Health Education Program (Other)
• Weight Loss Intervention (Behavioural Intervention)

Trial Overview The study is testing if a weight loss program can prevent breast cancer from returning in women who were overweight at diagnosis. It compares outcomes between those following a structured weight loss intervention and those receiving standard health education.

Participant Groups

Group I: Arm 2: Health Education Program + Weight Loss Intervention Experimental Treatment 2 Interventions

Patients will receive a standardized intervention focusing on healthy living as described in the Arm 1 (Health Education Program). In addition, patients will utilize a standardized, 2-year, telephone-based weight loss intervention. The intervention will include individual weight loss, caloric restriction, and physical activity goals for each participant. It will be administered through semi-structured phone calls delivered by trained coaches at the BWEL call center and supplemented through print and on-line materials. The intervention will utilize a toolbox approach that will allow for tailoring for the individual participant.

Group II: Arm 1: Health Education Program Experimental Treatment 1 Intervention

Patients will receive a standardized intervention focusing on healthy living. This will include mailings at study entry and one year later describing healthy lifestyle behaviors. All participants will also receive a 2-year subscription to a health magazine. In addition, all study participants will be invited to join twice-yearly Webinars/teleconferences that focus on breast cancer and other health topics, such as treatment updates in breast cancer, management of menopausal side effects, general cancer screening, etc. Finally, the study will also provide birthday and holiday greeting cards and a twice-yearly study newsletter with study updates and other general breast cancer news.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

NIH Biomarker, Imaging and Quality of Life Studies Funding Program (BIQSFP)

Collaborator

Trials

1

Recruited

3,200+

Canadian Cancer Trials Group

Collaborator

Trials

135

Recruited

70,300+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Division of Cancer Control

Collaborator

Trials

1

Recruited

3,200+