Dose-limiting Toxicities of Paclitaxel in Breast Cancer Patients: Studying Interactions Between Pharmacokinetics, Physical Activity, and Body Composition: an Observational Pilot Study.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This study looks into how a common breast cancer treatment, paclitaxel, can sometimes cause severe side effects that make it hard for patients to continue treatment. These side effects can significantly affect a patient's quality of life and even impact their recovery and overall health costs. What's interesting about this research is that it considers how a patient's lifestyle, specifically their physical activity levels and body makeup (like how much muscle and fat they have), might influence these side effects. The researchers are doing a detailed study with 40 women receiving paclitaxel treatment, tracking how the drug is processed in their bodies and how their body composition and physical activity might play a role in the side effects they experience. They are using a special method to monitor drug levels in the blood and are also keeping tabs on the patients' health and physical activity through questionnaires and modern tracking devices. The goal here is twofold: first, to better understand why these side effects happen to some people and not others, and second, to develop a model that can predict who might be at higher risk for these side effects based on their body composition, lifestyle, and how their body handles the drug. This could lead to more personalized treatment plans that could help reduce the risk of severe side effects and improve the overall treatment experience for patients with breast cancer. In simpler terms, this research is trying to find a way to make breast cancer treatment with paclitaxel safer and more comfortable by considering how a person's lifestyle and body type might affect their reaction to the drug. This could make a big difference in helping patients complete their treatment successfully and with a better quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
UZ Brussel
RECRUITING
Brussels
Vrije Universiteit Brussel
NOT_YET_RECRUITING
Brussels
Contact Information
Primary
Len De Nys
Len.de.nys@vub.be
+32 472 99 49 48
Time Frame
Start Date: 2024-07-30
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 40
Treatments
Breast Cancer Patients on Paclitaxel
Intervention: Paclitaxel Chemotherapy Generic Name: Paclitaxel Dosage Form: Intravenous infusion Dosage: 80 mg/m² Frequency: Once weekly Duration: 12 weeks
Related Therapeutic Areas
Sponsors
Collaborators: University Ghent, Vrije Universiteit Brussel
Leads: Universitair Ziekenhuis Brussel

This content was sourced from clinicaltrials.gov

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