Weight Loss Intervention for Breast Cancer Recurrence Prevention

Recruiting at 1510 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Must be taking: Hormonal therapy

Disqualifiers: Diabetes, Severe cardiovascular, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 2 years

3177 Participants Needed

What You Need to Know Before You Apply

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that hormonal therapy and certain other treatments are acceptable during the trial. It's best to discuss your specific medications with the trial team.

Is the Weight Loss Intervention for Breast Cancer Recurrence Prevention generally safe for humans?

Health and wellness coaching programs, which include weight loss interventions, have been used safely in various settings for conditions like obesity and diabetes. These programs are generally considered safe for humans, though more research is needed to optimize their effectiveness. ^{1 2 3 4 5}

How does this weight loss treatment for breast cancer recurrence prevention differ from other treatments?

This weight loss treatment is unique because it focuses on a comprehensive approach combining dietary changes, physical activity, and behavior modification, specifically targeting overweight or obese women with breast cancer to prevent recurrence. Unlike standard cancer treatments, this intervention is delivered through telephone-based coaching and aims for a 10% weight loss, which could potentially become a standard part of breast cancer care. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment for weight loss intervention in breast cancer recurrence prevention?

Research shows that weight loss interventions, like those involving health education and coaching, can help breast cancer survivors lose weight and improve their diet quality. These changes are linked to a lower risk of cancer coming back and better overall health. ^{7 10 11 12 13}

Who Is on the Research Team?

Jennifer Ligibel, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 2-year telephone-based weight loss intervention focusing on caloric restriction and physical activity, supplemented with print and online materials

2 years

Semi-structured phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 6 months for the first 3 years and then annually until 10 years from registration

10 years

Every 6 months for 3 years, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Health Education Program
• Weight Loss 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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

A pilot study involving 45 women treated for breast cancer showed that a Weight Watchers® referral program led to significant weight loss, with the Weight Watchers group losing an average of 6.03 kg by trial exit, compared to a slight gain in the control group.

The study found that while all groups showed improvements in quality of life, only the Weight Watchers group maintained significant weight loss benefits at 12 months, suggesting that the program is effective for weight management in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial. Newlands, RSN., Ntessalen, M., Clark, J., et al.[2022]

A group-based weight control intervention delivered via conference calls led to an average weight loss of 12.5 kg (13.9% of baseline weight) among obese breast cancer survivors in rural areas, demonstrating its efficacy in this population.

Participants also showed significant improvements in waist circumference, dietary habits, physical activity levels, and quality of life, including mood and body image, indicating that the intervention positively impacted both health and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a weight loss intervention among rural breast cancer survivors. Befort, CA., Klemp, JR., Austin, HL., et al.[2021]

The LEAN study showed that a 6-month lifestyle intervention for overweight or obese breast cancer survivors significantly improved diet quality, with the intervention group increasing their Healthy Eating Index (HEI) score by 6.8 points compared to 3.1 points in the usual care group.

Participants in the intervention group also achieved greater reductions in total and saturated fat intake, along with increases in fiber and fruit consumption, indicating that weight loss interventions can positively impact dietary habits in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in diet quality in a randomized weight loss trial in breast cancer survivors: the lifestyle, exercise, and nutrition (LEAN) study. Anderson, C., Harrigan, M., George, SM., et al.[2022]

A study involving 954 participants showed that a telephonic wellness coaching program led to a significant reduction in BMI, with a clinically meaningful decrease of over one unit after 12 months of coaching (P < 0.01).

In contrast, a matched control group of 19,080 individuals did not experience significant changes in BMI during the same period, highlighting the effectiveness of the wellness coaching intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of telephonic wellness coaching on weight loss: A "Natural Experiments for Translation in Diabetes (NEXT-D)" study. Schmittdiel, JA., Adams, SR., Goler, N., et al.[2019]

In a study of 225 participants in a telephonic health coaching program, those who engaged in at least 6 coaching sessions experienced a significant average weight loss of -3.5%, compared to a modest overall weight change of -2.1% for the group.

Despite the focus on weight management, the study found no significant changes in healthcare utilization or costs associated with program engagement, suggesting that while coaching can aid weight loss, it may not impact healthcare visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. Reid, N., Bennett, W., Coughlin, J., et al.[2020]

Health and wellness coaching (HWC) is effective for managing lifestyle diseases like obesity and type 2 diabetes, with recommended programming involving 12-15 sessions lasting 35-40 minutes each over a period of 7-9 months.

For obesity, a slightly more intense approach is suggested, with 15 sessions over 7-8 months, compared to 12 sessions over 9-10 months for diabetes, indicating tailored coaching intensity may be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosing of Health and Wellness Coaching for Obesity and Type 2 Diabetes: Research Synthesis to Derive Recommendations. Sforzo, GA., Kaye, MP., Faber, A., et al.[2023]

Health and wellness coaching (HWC) is emerging as an effective method for promoting lifestyle changes to prevent and treat chronic diseases like diabetes and heart disease, based on a systematic review of 219 articles, 150 of which were data-based.

The review highlights the need for further research to establish consensus on HWC definitions and standards, as the current literature is scattered and lacks a comprehensive summary, making it challenging for practitioners and researchers to access relevant information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compendium of the Health and Wellness Coaching Literature. Sforzo, GA., Kaye, MP., Todorova, I., et al.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes of a weight loss intervention among rural breast cancer survivors. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Changes in diet quality in a randomized weight loss trial in breast cancer survivors: the lifestyle, exercise, and nutrition (LEAN) study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of a parallel-arm randomized controlled weight loss pilot study on biological and psychosocial parameters of overweight and obese breast cancer survivors. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The impact of telephonic wellness coaching on weight loss: A "Natural Experiments for Translation in Diabetes (NEXT-D)" study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Evidence for success of caloric restriction in weight loss and control. Summary of data from industry. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Dosing of Health and Wellness Coaching for Obesity and Type 2 Diabetes: Research Synthesis to Derive Recommendations. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Compendium of the Health and Wellness Coaching Literature. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Weight Loss Intervention for Breast Cancer Survivors: A Systematic Review. [2020]

12. Spain pubmed.ncbi.nlm.nih.gov

A standardized, integral nutritional intervention and physical activity program reduces body weight in women newly diagnosed with breast cancer. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Weight Loss Intervention in Survivors of ER/PR-negative Breast Cancer. [2021]