Investigating Paclitaxel Toxicity in Breast Cancer: the Roles of Physical Activity and Body Composition.

Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the side effects of a common breast cancer treatment called paclitaxel. Some patients experience severe reactions to this medication, which can make it difficult for them to continue their treatment. The researchers want to find out if a person's lifestyle, like how active they are and their body composition (the mix of muscle and fat in their bodies), affects how they respond to paclitaxel and its side effects. They are looking for 40 women diagnosed with stage II or III breast cancer who are planning to undergo a specific treatment plan that includes 12 weeks of paclitaxel.

Participants in this study will have their blood monitored to see how the drug is processed in their bodies, and they will complete health and activity questionnaires. The goal is to understand why some people experience more side effects than others and to develop a way to predict who might be at risk based on their lifestyle and body type. This research aims to make breast cancer treatment safer and more comfortable, ultimately helping patients complete their treatment while improving their quality of life.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Female patients with a diagnosis of breast cancer: Specifically targeting those diagnosed with stage II or III breast cancer, to understand the effects of paclitaxel within a somewhat uniform disease severity group.
• • Planned for 12 cycles of Paclitaxel (PTX) in a (neo-)adjuvant setting: The study focuses on patients scheduled to undergo a standard 12-week, once-a-week paclitaxel chemotherapy regimen as part of their treatment plan.
• • Age 18 or older in (pre-)menopausal status: Adult patients of any menopausal status are eligible, ensuring a wide demographic representation.
• • Prior taxane use is allowed if treatment in the adjuvant setting finished over a year ago: This criterion allows for the inclusion of patients who may have previously undergone taxane-based treatments, provided there has been a sufficient washout period to minimize the influence of prior treatments on the study outcomes.
• • Exclusion Criteria
• • Cognitive impairment (unable to understand test instructions): Ensuring participants can comprehend and follow study procedures and requirements is crucial for data integrity and participant safety.
• • Participation in clinical trials of experimental drugs: To avoid confounding effects from other investigational treatments and focus on the impact of standard-of-care paclitaxel therapy.
• • Documented intolerance or allergy to PTX (non-documented intolerance or allergy will lead to drop-out): Participants must be able to tolerate paclitaxel, as adverse reactions could compromise their safety and affect study results.
• • Interacting drugs in home medication: Patients using medications known to interact with paclitaxel could experience altered drug metabolism or increased toxicity, potentially skewing study outcomes.
• • Male sex: The study is focused on breast cancer in female patients, as the disease's presentation, treatment, and outcomes can vary significantly between genders.
• • Age under 18 years: Ensuring all participants are legal adults helps adhere to ethical standards and regulatory requirements concerning consent and participation in clinical research.