Investigating Paclitaxel Toxicity in Breast Cancer: the Roles of Physical Activity and Body Composition.
- Conditions
- Chemotherapeutic Agent ToxicityBody WeightPaclitaxel Adverse ReactionPhysical InactivityBreast CancerChemotherapeutic Toxicity
- Interventions
- Registration Number
- NCT06387901
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Breast Cancer Patients on Paclitaxel Paclitaxel Chemotherapy Intervention: Paclitaxel Chemotherapy Generic Name: Paclitaxel Dosage Form: Intravenous infusion Dosage: 80 mg/m² Frequency: Once weekly Duration: 12 weeks
- Primary Outcome Measures
Name Time Method 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 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 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.
- Secondary Outcome Measures
Name Time Method Number and Type of Dose-Limiting Toxicities DLTs recorded the week following paclitaxel infusion cycles 1, 6, 9, and 12 (each cycle is 7 days). Documentation and analysis of the number and type of DLTs experienced by participants, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) classification v5.0. This includes monitoring for neutropenia and chemotherapy-induced peripheral neuropathy among other toxicities.
Paclitaxel Exposure Analysis (Cmax) Blood samples collected and analyzed at cycles 1 (week 1), 6 (week 6), 9 (week 9), and 12 (week 12) post-paclitaxel infusion. Each cycle is 7 days. Evaluation of paclitaxel exposure by measuring blood serum concentrations to determine the maximum concentration remains above the threshold of 0.05 µmol/L, which is predictive of DLTs in breast cancer patients.
Paclitaxel Exposure Analysis (AUC) Blood samples collected and analyzed at cycles 1 (week 1), 6 (week 6), 9 (week 9), and 12 (week 12) post-paclitaxel infusion. Each cycle is 7 days. Evaluation of paclitaxel exposure by measuring blood serum concentrations to determine the duration of time the concentration remains above the threshold of 0.05 µmol/L, which is predictive of DLTs in breast cancer patients.
Trial Locations
- Locations (2)
UZ Brussel
🇧🇪Brussels, Jette, Belgium
Vrije Universiteit Brussel
🇧🇪Brussel, Jette, Belgium