Investigating how physical activity and body composition affect paclitaxel toxicity in breast cancer patients
Dose-limiting Toxicities of Paclitaxel in Breast Cancer Patients: Studying Interactions Between Pharmacokinetics, Physical Activity, and Body Composition: an Observational Pilot Study.
This study is trying to see how exercise and body weight affect the side effects of a common breast cancer drug in women undergoing treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Brussels, Jette and 1 other locations) |
| Trial ID | NCT06387901 on ClinicalTrials.gov |
What this trial studies
This observational study examines the side effects of paclitaxel, a common chemotherapy drug for breast cancer, and how factors like physical activity and body composition may influence these adverse reactions. It involves 40 women diagnosed with stage II or III breast cancer who are scheduled to receive 12 cycles of paclitaxel treatment. Researchers will monitor drug levels in the blood and assess patients' health and activity levels through questionnaires and tracking devices. The aim is to better understand the relationship between lifestyle factors and chemotherapy side effects, potentially improving patient care.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 or older with stage II or III breast cancer who are scheduled to receive paclitaxel chemotherapy.
Not a fit: Patients with cognitive impairments that prevent them from understanding the study requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that minimize side effects and improve the quality of life for breast cancer patients undergoing chemotherapy.
How similar studies have performed: While there have been studies examining chemotherapy side effects, this specific focus on physical activity and body composition in relation to paclitaxel toxicity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brussels, Jette and 1 other locations
- UZ Brussel — Brussels, Jette, Belgium (Recruiting)
- Vrije Universiteit Brussel — Brussels, Jette, Belgium (Not_yet_recruiting)
Study contacts
- Principal investigator: Nele Adriaenssens, PhD — Vrije Universiteit Brussel
- Study coordinator: Len De Nys
- Email: Len.de.nys@vub.be
- Phone: +32 472 99 49 48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.