Research Studies:

Exercise Protocol Feasibility

for TNBC Immunotherapy

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Status: Active

Evaluating the feasibility of an MCI/Neoadjuvant Exercise Protocol in combination with immunotherapy and chemotherapy for Triple Negative Breast Cancer (TNBC) patients.

Project Sponsor: Baptist Health South Florida

Project Investigator: Ana Cristina Sandoval Leon, MD

Date: July-December 2024

Purpose of the Study

The primary aim of this study is to assess the feasibility and potential benefits of incorporating a structured exercise protocol with standard immunotherapy and chemotherapy treatments in patients diagnosed with Triple Negative Breast Cancer (TNBC). This project addresses key questions such as:

Can an exercise protocol improve the efficacy of immunotherapy and chemotherapy in TNBC patients?
What are the impacts of combined treatment on patients' overall health and quality of life?
How feasible is implementing this combined treatment approach in a clinical setting?

We hope to facilitate more holistic and effective treatment strategies for TNBC patients by answering these questions.

Background

Triple Negative Breast Cancer (TNBC) is a particularly aggressive form of breast cancer that lacks estrogen, progesterone, and HER2 receptors, making it challenging to treat with standard hormone therapies. Current treatments primarily include chemotherapy and immunotherapy, but significant side effects and varying efficacy can accompany these.

Emerging evidence suggests that exercise can enhance the effectiveness of cancer treatments, improve patients' physical and mental health, and reduce treatment-related side effects. This study explores these potential benefits by integrating a Metabolic Conditioning Intervention (MCI) and a Neoadjuvant Exercise Protocol with conventional TNBC treatments.

Methodology

The study employs a comprehensive approach to evaluate the feasibility of the combined treatment protocol:

1. Participant Selection: TNBC patients undergoing immunotherapy and chemotherapy are selected based on specific inclusion criteria.

2. Focus group- Conduct a study with selected participants to obtain qualitative data.

3. Exercise Protocol: Qualified professionals develop and supervise a tailored exercise regimen focusing on metabolic conditioning and strength training.

4. Treatment Integration: The exercise protocol integrates with patients' immunotherapy and chemotherapy schedules.

5. Data Collection: Health metrics, treatment efficacy, side effects, and quality of life are monitored and recorded throughout the study.

6. Data Analysis: Advanced statistical tools analyze the collected data, comparing outcomes between those following the combined treatment and those receiving standard care.

Key Areas of Focus

Treatment Efficacy: Assessing whether the combined protocol improves the effectiveness of cancer treatments.
Patient Health: Monitoring physical health, including strength, endurance, and metabolic function.
Quality of Life: Evaluating the mental and emotional well-being of patients, focusing on stress, anxiety, and overall life satisfaction.
Feasibility: Determining the practicality of implementing the combined treatment in a real-world clinical setting.