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Active not recruitingPHASE3INTERVENTIONAL

Breast Cancer WEight Loss Study (BWEL Study)

The 'Breast Cancer WEight Loss Study' (BWEL Study) is investigating if weight loss can prevent breast cancer from returning in women who are overweight or obese. Previous research has hinted that heavier women diagnosed with breast cancer might face a higher chance of their cancer coming back compared to thinner women. This study aims to find out if joining a weight loss program after being diagnosed with breast cancer leads to a lower rate of the cancer recurring. It will compare a group taking part in a weight loss programme with a group receiving general health advice. The results will help determine if weight loss programs should become a standard part of breast cancer treatment for some patients.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Alliance for Clinical Trials in Oncology
Enrolment target
3,177
Start
16 Sep 2016
Estimated completion
30 May 2030

What is this study about?

This study, called the BWEL Study, is looking into an important question: can losing weight after being diagnosed with breast cancer help stop the cancer from coming back? We know from earlier studies that women who are overweight or obese when they find out they have breast cancer might have a greater chance of the cancer returning in the future.

The main goal of this study is to see if a weight loss program can change this. Researchers will compare two groups of women: one group will take part in a supervised weight loss program, and the other group will receive general health advice. By comparing these two groups, scientists hope to learn if losing weight actually helps reduce the risk of breast cancer recurrence. They will also look at how weight loss impacts overall health and survival.

Ultimately, the results of this study will help doctors and patients understand whether weight loss programs should be included as part of the overall treatment plan for breast cancer. This could make a real difference in how breast cancer is managed and help improve the long-term health of many women.

Key takeaways

  • This study investigates if weight loss can prevent breast cancer from returning.
  • It targets women who are overweight or obese after their breast cancer diagnosis.
  • Participants will either be in a weight loss program or receive health education.
  • The study aims to see if weight loss should be part of breast cancer treatment.
  • It will follow participants for up to 10 years to gather long-term information.
  • Findings could help improve future breast cancer care.

Who may be eligible?

To join this study, you must be a woman who has been diagnosed with invasive breast cancer. This diagnosis must have happened within the last 14 months. It's important that your cancer is **not** HER2-positive and has **not** spread to other parts of your body. Your breast cancer must also fall into specific categories based on its size and whether it has spread to nearby lymph nodes.

You also need to be overweight or obese, which doctors usually measure using your Body Mass Index (BMI). Your BMI must be 27 or higher.

The study is for adults, so you need to be at least 18 years old. Different types of breast cancer are suitable, but your doctors will need to check the specific details of your cancer diagnosis to confirm if you meet all the requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am a woman diagnosed with invasive breast cancer within the last 14 months.
  2. My breast cancer is HER2-negative.
  3. My breast cancer has not spread to other parts of my body.
  4. I am aged 18 or over.
  5. My BMI (Body Mass Index) is 27 or higher.
  6. My doctor has confirmed my specific cancer type (TNM stage, hormone receptor status) meets the study criteria.
Answer every question to see your result.

What does participation involve?

If you join this study, you will be placed into one of two groups by chance, like flipping a coin. One group will participate in a supervised weight loss program, which will mainly involve phone calls for support and guidance. The other group will receive health education materials. You will not know which group you are in until after you join.

The study will follow participants for a long time, up to 10 years, to see the long-term effects. During this time, you will have regular check-ups and assessments to monitor your health, weight, and whether your cancer has returned. The goal is to see if the weight loss program makes a difference over many years.

Potential risks and benefits

Participating in this study might offer the benefit of a structured weight loss program, which could improve your general health and potentially reduce your risk of breast cancer recurrence, though this is what the study aims to prove. You would also contribute to valuable knowledge that could help future patients. Potential risks are generally low, as weight loss programs are usually safe, but there could be minor discomforts or lifestyle adjustments involved. As with any medical study, you are free to withdraw at any time without affecting your medical care.

Locations (1498)

  • Southern Cancer Center PC-Daphne
    Verified postcode
    Daphne, United States
  • Southern Cancer Center PC-Mobile
    Verified postcode
    Mobile, United States
  • Southern Cancer Center PC-Providence
    Verified postcode
    Mobile, United States
  • Southern Cancer Center PC-Springhill
    Verified postcode
    Mobile, United States
  • Anchorage Associates in Radiation Medicine
    Verified postcode
    Anchorage, United States
  • Anchorage Radiation Therapy Center
    Verified postcode
    Anchorage, United States
  • Alaska Breast Care and Surgery LLC
    Verified postcode
    Anchorage, United States
  • Alaska Oncology and Hematology LLC
    Verified postcode
    Anchorage, United States
  • Alaska Women's Cancer Care
    Verified postcode
    Anchorage, United States
  • Anchorage Oncology Centre
    Verified postcode
    Anchorage, United States
  • Katmai Oncology Group
    Verified postcode
    Anchorage, United States
  • Providence Alaska Medical Center
    Verified postcode
    Anchorage, United States

Common questions

What is 'recurrence'?

Recurrence means the breast cancer has come back after treatment. This study is trying to find ways to prevent that from happening.

What does being 'overweight' or 'obese' mean in this study?

It refers to your Body Mass Index (BMI). In this study, it means a BMI of 27 or higher, which doctors use to measure if a person is at a healthy weight for their height.

Will I know if I'm in the weight loss group or the health advice group?

No, you won't know which group you're in at first. This is done to make sure the study results are fair and unbiased.

How long will I be followed in this study?

The study will follow participants for up to 10 years to see the long-term effects of the interventions.

Is this study only for women?

Yes, this specific study is focusing on women who have been diagnosed with breast cancer.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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