What is the mechanism of action of this treatment?

Common treatments for breast cancer include hormone therapy, chemotherapy, and targeted therapy. Hormone therapy blocks hormones that fuel cancer growth, chemotherapy kills rapidly dividing cells, and targeted therapy focuses on specific cancer-related molecules. The A-NEW study's combination of pharmacotherapy and behavioral weight loss interventions aims to improve overall health, potentially enhancing treatment efficacy by reducing inflammation and improving metabolic health, which is crucial for breast cancer patients.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving pharmacotherapy and weight loss interventions, can have various side effects. Pharmacotherapy, such as the use of SSRIs or antiepileptics, may cause nausea, headache, dizziness, dry mouth, and changes in appetite. Weight loss medications can also lead to gastrointestinal issues, increased heart rate, and insomnia. Lifestyle and dietary changes, while generally beneficial, may initially cause fatigue, muscle soreness, and digestive adjustments as the body adapts to new routines. It is important for patients to discuss these potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including hormone therapies, chemotherapy, targeted therapies, and immunotherapies. In the context of weight loss interventions for breast cancer survivors, medications such as orlistat and SSRIs (e.g., fluoxetine) have been studied for their potential benefits in weight management and behavioral health. These treatments are often combined with lifestyle and dietary changes to enhance overall health outcomes. The trial mentioned focuses on the combined effect of pharmacotherapy and remote behavioral interventions, which aligns with the broader approach of integrating medication with lifestyle modifications to support weight loss and improve biomarkers in breast cancer survivors.

What other types of research exist?

Promising novel alternatives for breast cancer patients considering weight loss treatment in 2024 include: 1) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown improvements in psychological well-being and sleep-related quality of life, potentially aiding overall health and weight management. 2) Combination therapies such as naltrexone/bupropion, which have demonstrated efficacy in weight management and may offer additional benefits for mood and psychological health. 3) Emerging pharmacological agents like SR13668, an Akt pathway inhibitor, which is under investigation for its potential in cancer chemoprevention and may have implications for weight management and overall health in cancer patients.

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Anti-obesity agent

Drug + Behavioral Weight Loss for Obesity (A-NEW Trial)

Phase 2

Waitlist Available

Led By Jennifer Sheng

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 months and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a weight loss medication and a remote coaching program to help overweight or obese breast cancer survivors lose weight. Participants receive phone support from a coach, and those who don't lose enough weight will start taking the medication. The study aims to see if this approach helps with weight loss and improves health markers.

Who is the study for?

This trial is for female breast cancer survivors who are overweight or obese, finished local therapy at least 3 months ago, and have not had any serious medical conditions that could affect weight measurement. They must be willing to change their diet and exercise habits, track behaviors, attend regular contacts and visits, take a chronic weight loss medication, and have stable internet access.

What is being tested?

The A-NEW Study is testing the combination of a drug called Contrave with a remote behavioral weight loss program to see if they help in losing weight. It also looks at how this weight loss might change certain blood markers and gut bacteria in these women.

What are the potential side effects?

Possible side effects from Contrave include nausea, constipation, headache, vomiting, dizziness, trouble sleeping (insomnia), dry mouth and diarrhea. The behavioral intervention may cause changes in mood or behavior due to lifestyle adjustments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 months and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 months and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with 5 percent weight loss (in SLOW-BWL)

Secondary study objectives

Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to

+5 more

Other study objectives

Number of patients with 5% weight loss (in FAST-BWL)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SLOW-BWLExperimental Treatment2 Interventions

All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose \<5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave \[as per the Food and Drug Administration (FDA) recommended administration\] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6.

Group II: FAST-BWLActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contrave

2021

Completed Phase 4

~150

Behavioral Weight Loss

2011

Completed Phase 2

~380

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include hormone therapy, chemotherapy, and targeted therapy. Hormone therapy blocks hormones that fuel cancer growth, chemotherapy kills rapidly dividing cells, and targeted therapy focuses on specific cancer-related molecules. The A-NEW study's combination of pharmacotherapy and behavioral weight loss interventions aims to improve overall health, potentially enhancing treatment efficacy by reducing inflammation and improving metabolic health, which is crucial for breast cancer patients.