Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Belgium / NCT06387901
Recruiting Observational

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

NCT06387901 · tracked via the Priya Life Science Belgium tracker
Sponsor
Universitair Ziekenhuis Brussel
Phase
Observational
Started
2024-07-30
Last updated
2024-11-01

Condition(s) studied

Breast CancerPaclitaxel Adverse ReactionChemotherapeutic ToxicityChemotherapeutic Agent ToxicityBody WeightPhysical Inactivity

Investigational drug(s) / intervention(s)

Paclitaxel Chemotherapy

Paclitaxel Chemotherapy: Participants will receive paclitaxel, a taxane chemotherapeutic agent used in the treatment of breast cancer. The administration involves an intravenous infusion of paclitaxel at a dosage of 80 mg/m². The treatment is scheduled once a week, continuing for a total duration of 12 weeks. This regimen is part of a (neo-)adjuvant therapy for female patients diagnosed with stage II or III breast cancer. The intervention aims to assess the pharmacokinetics of paclitaxel in relation to patient body composition and physical activity, evaluating its impact on dose-limiting toxicities and overall treatment efficacy.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Identification of Body Composition Parameter (Muscle mass) Related to Dose-Limiting Toxicities (DLTs) — Assessed through the 12-week treatment period, with measurements at baseline, cycles (each cycle is 7 days), 1 (week 1), 6 (week 6), 9 (week 9), and 12 (week 12).
    This outcome measure aims to identify specific parameters related to the body composition (muscle mass (Kg)) that influence the occurrence and severity of dose-limiting toxicities in breast cancer patients undergoing paclitaxel treatment.
  • Identification of Body Composition Parameters (Fat %) Related to Dose-Limiting Toxicities (DLTs) — Assessed through the 12-week treatment period, with measurements at baseline, cycles (each cycle is 7 days), 1 (week 1), 6 (week 6), 9 (week 9), and 12 (week 12).
    This outcome measure aims to identify specific parameters related to the body composition (fat (%)) that influence the occurrence and severity of dose-limiting toxicities in breast cancer patients undergoing paclitaxel treatment.
  • Identification of Physical Activity Parameters Related to Dose-Limiting Toxicities (DLTs) — Assessed through the 12-week treatment period, with measurements at baseline, cycles (each cycle is 7 days), 1 (week 1), 6 (week 6), 9 (week 9), and 12 (week 12).
    This outcome measure aims to identify specific parameters related to physical activity levels that influence the occurrence and severity of dose-limiting toxicities in breast cancer patients undergoing paclitaxel treatment.

Trial sites (2)

FacilityCityRegionStatus
UZ Brussel Brussels Jette Recruiting
Vrije Universiteit Brussel Brussels Jette Not Yet Recruiting

More Universitair Ziekenhuis Brussel trials in Belgium

Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT) Recruiting
Partial Range Of Field IOLs in DMEK-Enabled Procedures Starting soon
Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis Recruiting
Reliability of a Food Frequency Questionnaire in the Assessment of Dietary Intake Including FODMAPs in Different Populations, and Relationship With IBS Symptoms and the Degree of Self-assessed Physical Activity Recruiting
Fertility in Young Adults Who Did (Not) Store Testicular Tissue Before a Treatment Leading to Fertility Problems Enrolling by invitation

Other trials for the same condition

Male Breast Cancer: Understanding the Biology for Improved Patient Care Active, not recruiting
A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment Recruiting
PALbociclib CoLlaborative Adjuvant Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06387901 on ClinicalTrials.gov ↗ ← All trials in Belgium