protocolSection identificationModule nctId: NCT06387901, orgStudyIdInfo id: PABTOX - part 1, briefTitle: Investigating Paclitaxel Toxicity in Breast Cancer: The Roles of Physical Activity and Body Composition., acronym: PABTOX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-05-06, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Universitair Ziekenhuis Brussel, class: OTHER, collaborators name: Vrije Universiteit Brussel, collaborators name: University Ghent, descriptionModule briefSummary: 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., conditionsModule conditions: Breast Cancer, conditions: Paclitaxel Adverse Reaction, conditions: Chemotherapeutic Toxicity, conditions: Chemotherapeutic Agent Toxicity, conditions: Body Weight, conditions: Physical Inactivity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Paclitaxel Chemotherapy, outcomesModule primaryOutcomes measure: Identification of Body Composition Parameter (Muscle mass) Related to Dose-Limiting Toxicities (DLTs), primaryOutcomes measure: Identification of Body Composition Parameters (Fat %) Related to Dose-Limiting Toxicities (DLTs), primaryOutcomes measure: Identification of Physical Activity Parameters Related to Dose-Limiting Toxicities (DLTs), secondaryOutcomes measure: Paclitaxel Exposure Analysis (Cmax), secondaryOutcomes measure: Paclitaxel Exposure Analysis (AUC), secondaryOutcomes measure: Number and Type of Dose-Limiting Toxicities, otherOutcomes measure: Treatment-Related Adverse Events, otherOutcomes measure: Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (muscle mass), otherOutcomes measure: Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (fat %), otherOutcomes measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (muscle mass), otherOutcomes measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (fat mass), otherOutcomes measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (extracellular fluid), otherOutcomes measure: The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30), otherOutcomes measure: EORTC QLQ-BR45 Breast (BR) Cancer Module, otherOutcomes measure: EORTC QLQ- Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20, otherOutcomes measure: European Health Interview Survey Physical Activity Questionnaire (EHIS PAQ), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vrije Universiteit Brussel, city: Brussel, state: Jette, zip: 1090, country: Belgium, contacts name: Nele Adriaenssens, role: CONTACT, phone: +32 2 476 36 23, email: Nele.Adriaenssens@vub.be, contacts name: Len De Nys, role: CONTACT, phone: +32 472 99 49 48, email: Len.de.nys@vub.be, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False