Weight-Loss Program for Lowering Breast Cancer Risk in Obesity

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Oral antidiabetics, GLP-1 agonists

Disqualifiers: Type 1 diabetes, Type 2 diabetes, Cancer treatment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

51 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This pilot trial studies how well a diabetes prevention program with or without hunger training works in helping to lower breast cancer risk in obese participants. A diabetes prevention program involves learning about and receiving materials on different strategies to encourage weight loss, and hunger training involves learning how to recognize hunger. It is not yet known whether adding hunger training to a diabetes prevention program helps participants control their weight that could reduce the risk of some cancers.

Will I have to stop taking my current medications?

The trial requires that you do not use oral antidiabetic agents (except metformin) and certain other medications that could interfere with glucose metabolism. If you are on these medications, you may need to stop them to participate.

Is the Diabetes Prevention Program safe for humans?

The Diabetes Prevention Program (DPP) has been evaluated in large clinical trials and is considered safe for humans. It involves lifestyle changes like diet and exercise to prevent diabetes, and no major safety concerns have been reported in these studies. ^{1 2 3 4 5}

How is the Diabetes Prevention Program (DPP) treatment unique for lowering breast cancer risk in obesity?

The Diabetes Prevention Program (DPP) is unique because it focuses on lifestyle changes, such as diet and exercise, to achieve weight loss, which can lower the risk of developing diabetes and potentially reduce breast cancer risk in obese individuals. Unlike other treatments that might involve medication, the DPP emphasizes behavior modifications and education to promote long-term health improvements. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Diabetes Prevention Program (DPP) for lowering breast cancer risk in obesity?

The Diabetes Prevention Program (DPP) is known for its success in reducing the risk of developing diabetes by 58% over three years through lifestyle changes like diet and exercise. While it is primarily used for diabetes prevention, its focus on weight loss and healthy living could potentially help lower breast cancer risk in obese individuals, as weight loss is generally associated with reduced cancer risk. ^{1 2 4 5 6}

Who Is on the Research Team?

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for obese individuals at high risk of developing breast cancer, which includes those with a BMI >= 27 kg/m^2, history of certain breast conditions or BRCA1/2 mutations. Participants must have had no menstrual cycle for 12 months or undergone bilateral oophorectomy, be proficient in English, and able to take digital photos. Those actively treated for cancer (except nonmelanoma skin cancer), with diabetes or using specific glucose-affecting drugs cannot join.

Inclusion Criteria

I am at high risk for breast cancer due to genetic factors or previous conditions.

I have not had a period for 12 months or have had both ovaries removed.

Internet access (daily)

Exclusion Criteria

I am taking medication for diabetes in pill form.

I am not taking any medication that affects blood sugar, except possibly metformin.

I am currently receiving treatment for a cancer that is not nonmelanoma skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take part in the Diabetes Prevention Program (DPP) once a week over 1 hour for 16 weeks. Group B also receives hunger training once a week during weeks 2-6.

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for changes in weight, metabolic and breast cancer risk biomarkers, and behavioral mediators.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Prevention Program
• Hunger Training

Trial Overview The study is testing whether adding hunger training to a diabetes prevention program helps obese participants control their weight better and thus reduce the risk of breast cancer. Hunger training teaches how to recognize true hunger cues. The effectiveness will be compared between those who only receive the diabetes prevention program and those who also get hunger training.

How Is the Trial Designed?

Group I: Group B (DPP-HT) Experimental Treatment 2 Interventions

Participants take part in DPP once a week over 1 hour for 16 weeks and hunger training once a week during weeks 2-6.

Group II: Group A (DPP) Active Control 2 Interventions

Participants take part in DPP once a week over 1 hour for 16 weeks.

Diabetes Prevention Program is already approved in United States for the following indications:

Approved in United States as National Diabetes Prevention Program (NDPP) for:

• Prediabetes
• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The Diabetes Prevention Program (DPP) can reduce the incidence of diabetes by 58% over three years for individuals with prediabetes, yet most patients are unaware of their condition.

With Medicare coverage starting in 2018, the DPP has become more accessible for patients over 65, highlighting the need for healthcare providers to implement screening and referral processes for prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. Jasik, CB., Joy, E., Brunisholz, KD., et al.[2019]

A randomized clinical trial involving 257 obese patients with metabolic syndrome showed that a group conference call (CC) intervention led to significantly greater weight loss (-5.6%) compared to individual calls (IC) (-1.8%) over 2 years, indicating that group support may enhance weight loss outcomes.

Participants in the CC group not only lost more weight but also continued to lose weight between the first and second year, while those in the IC group began to regain weight, highlighting the importance of ongoing support in lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. Weinstock, RS., Trief, PM., Cibula, D., et al.[2022]

The Diabetes Prevention Program (DPP) is a large clinical trial involving 3,234 participants aimed at evaluating interventions to prevent type 2 diabetes in individuals at high risk, with a diverse demographic including various ethnic backgrounds and age groups.

The study will assess the effectiveness of three treatment approaches: intensive lifestyle modification, standard care with metformin, and standard care with placebo, to determine their impact on delaying or preventing diabetes development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group. [2022]

In a modified Diabetes Prevention Program (DPP) for patients with non-alcoholic fatty liver disease (NAFLD), 79% of participants completed the program, leading to significant weight loss and improvements in liver health indicators over 12 months.

Key improvements included reduced hepatic steatosis and liver enzymes, indicating enhanced liver function, although there was a noted increase in low-density lipoprotein levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. Hershman, M., Torbjornsen, K., Pang, D., et al.[2023]

The Intensive Lifestyle Intervention (ILI) in the Diabetes Prevention Program (DPP) effectively helped approximately 3800 high-risk adults with prediabetes achieve weight loss through dietary and exercise modifications, demonstrating a practical approach to delaying or preventing type 2 diabetes.

The DPP and its follow-up, the DPP Outcomes Study (DPPOS), highlight the importance of lifestyle changes in managing prediabetes, particularly in a diverse population, suggesting that these interventions can be tailored to various ethnic backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Diabetes Through the Lifestyle Intervention: Lessons Learned from the Diabetes Prevention Program and Outcomes Study and its Translation to Practice. Hoskin, MA., Bray, GA., Hattaway, K., et al.[2019]

In a study of 1,007 participants in the National Diabetes Prevention Program, individuals lost an average of 4% of their initial body weight, with about one-third achieving over 5% weight loss, indicating the program's overall efficacy in promoting weight loss.

After controlling for program attendance and physical activity, no significant disparities in weight loss outcomes were found among different demographic groups, although lower attendance and physical activity levels were noted in non-Hispanic Black and Hispanic participants, suggesting a need for targeted strategies to enhance their engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Disparities Among Hispanic and Underserved Participants, Colorado, 2015-2018. Clennin, MN., Maytag, A., Ellis, J., et al.[2021]

Citations

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

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. [2019]

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

Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. [2022]

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

The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group. [2022]

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

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. [2023]

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

Prevention of Diabetes Through the Lifestyle Intervention: Lessons Learned from the Diabetes Prevention Program and Outcomes Study and its Translation to Practice. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of the Diabetes Prevention Program for Obesity Treatment in Real World Clinical Practice in a Middle-Income Country in Latin America. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Rural/urban disparities in access to the National Diabetes Prevention Program. [2021]

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

Cardiometabolic Risk Factor Changes Observed in Diabetes Prevention Programs in US Settings: A Systematic Review and Meta-analysis. [2018]

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

Weight Loss Disparities Among Hispanic and Underserved Participants, Colorado, 2015-2018. [2021]