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Paclitaxel

Albumin-Bound Paclitaxel

Taxane

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Antimitotic Agents

Intervention: Paclitaxel Chemotherapy Generic Name: Paclitaxel Dosage Form: Intravenous infusion Dosage: 80 mg/m² Frequency: Once weekly Duration: 12 weeks

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.

Paclitaxel Chemotherapy

Len De Nys

Nele Adriaenssens

Nele Adriaenssens, PhD

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.

Blood samples, taken within 10 minutes as well as between 16 and 26 hours post-PTX infusion.

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

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

The protocol emphasizes adherence to General Data Protection Regulation (GDPR) and mentions data storage and management practices to ensure confidentiality and security. However, it does not specify arrangements for sharing IPD outside the research team or with the broader scientific community post-study.

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

This outcome measure involves assessing muscle mass (kg), using Bioelectrical Impedance Analysis (BIA). The aim is to determine the impact of body composition on pharmacokinetics and the occurrence of dose-limiting toxicities (DLTs) in breast cancer patients undergoing paclitaxel treatment.

This outcome measure involves assessing fat %, using Bioelectrical Impedance Analysis (BIA). The aim is to determine the impact of body composition on pharmacokinetics and the occurrence of dose-limiting toxicities (DLTs) in breast cancer patients undergoing paclitaxel treatment.

This outcome measure involves the use of Dual X-ray Absorptiometry (DEXA) to assess skeletal muscle mass (kg) in the whole body and segmented regions. This analysis aims to explore the relationship between body composition and the pharmacodynamics of paclitaxel, focusing on its efficacy and toxicity.

This outcome measure involves the use of Dual X-ray Absorptiometry (DEXA) to assess fat mass (kg) in the whole body and segmented regions. This analysis aims to explore the relationship between body composition and the pharmacodynamics of paclitaxel, focusing on its efficacy and toxicity.

This outcome measure involves the use of Dual X-ray Absorptiometry (DEXA) to assess extracellular fluid (L), in the whole body and segmented regions. This analysis aims to explore the relationship between body composition and the pharmacodynamics of paclitaxel, focusing on its efficacy and toxicity.

The EORTC QLQ-C30 is a well-established instrument designed to assess the quality of life in cancer patients. It covers various dimensions including physical, emotional, and social functioning, as well as symptoms related to cancer and its treatment. This questionnaire aims to evaluate how paclitaxel treatment impacts the overall well-being and daily functioning of breast cancer patients.

This questionnaire is an add-on module to the QLQ-C30 for patients with breast cancer. It assesses symptoms and side effects specific to breast cancer and its treatment, body image, sexual functioning, and future perspective. The aim is to capture the specific quality of life concerns of breast cancer patients undergoing paclitaxel treatment.

The QLQ-CIPN20 is designed to assess symptoms of chemotherapy-induced peripheral neuropathy, a common side effect of paclitaxel. It evaluates sensory, motor, and autonomic symptoms related to neuropathy. This questionnaire will help quantify the extent of neuropathic side effects experienced by the patients and their impact on daily activities and quality of life.

The EHIS PAQ is designed to gather comprehensive data on physical activity levels in various domains, including work, leisure time, and daily activities. This tool will assess changes in physical activity patterns among breast cancer patients receiving paclitaxel and explore correlations with treatment outcomes and quality of life.

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.

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.

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Investigating Paclitaxel Toxicity in Breast Cancer: The Roles of Physical Activity and Body Composition.	NCT06387901	Breast Cancer Paclitaxel Adve... Chemotherapeuti... Chemotherapeuti... Body Weight Physical Inacti...	Paclitaxel Chem...	18 Years -	Universitair Ziekenhuis Brussel
Investigating Paclitaxel Toxicity in Breast Cancer: The Roles of Physical Activity and Body Composition.	NCT06387901	Breast Cancer Paclitaxel Adve... Chemotherapeuti... Chemotherapeuti... Body Weight Physical Inacti...	Paclitaxel Chem...	18 Years -	Universitair Ziekenhuis Brussel
Investigating Paclitaxel Toxicity in Breast Cancer: The Roles of Physical Activity and Body Composition.	NCT06387901	Breast Cancer Paclitaxel Adve... Chemotherapeuti... Chemotherapeuti... Body Weight Physical Inacti...	Paclitaxel Chem...	18 Years -	Universitair Ziekenhuis Brussel

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