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.
Study Type
OBSERVATIONAL
Enrollment
40
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.
UZ Brussel
Brussels, Jette, Belgium
RECRUITINGVrije Universiteit Brussel
Brussels, Jette, Belgium
NOT_YET_RECRUITINGIdentification of Body Composition Parameter (Muscle mass) Related to Dose-Limiting Toxicities (DLTs)
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.
Time frame: 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).
Identification of Body Composition Parameters (Fat %) Related to Dose-Limiting Toxicities (DLTs)
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.
Time frame: 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).
Identification of Physical Activity Parameters Related to Dose-Limiting Toxicities (DLTs)
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.
Time frame: 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).
Paclitaxel Exposure Analysis (Cmax)
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.
Time frame: 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.
Paclitaxel Exposure Analysis (AUC)
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.
Time frame: 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.
Number and Type of Dose-Limiting Toxicities
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.
Time frame: DLTs recorded the week following paclitaxel infusion cycles 1, 6, 9, and 12 (each cycle is 7 days).
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