Clinical trial NCT06387901: Investigating Paclitaxel Toxicity in Breast Cancer: the Roles of Physical Activity and Body Composition.
Official title: Dose-limiting Toxicities of Paclitaxel in Breast Cancer Patients: Studying Interactions Between Pharmacokinetics, Physical Activity, and Body Composition: an Observational Pilot Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Paclitaxel Adverse Reaction
Chemotherapeutic Toxicity
Chemotherapeutic Agent Toxicity
Body Weight
Physical Inactivity
Keywords: breast cancer
chemotherapy
physical activity
body composition
muscle mass
fat mass
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
name: University Ghent
First posted: 2024-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of female patients diagnosed with stage II or III breast cancer, identified from the Medical Oncology Department of UZ Brussel, Belgium. Eligible participants are those scheduled for a standard 12-week, once-weekly paclitaxel (PTX) chemotherapy regimen in a (neo-)adjuvant setting. Inclusion criteria ensure a diverse cohort in terms of menopausal status, with prior taxane treatment permissible if concluded over a year prior. Exclusion criteria aim to maintain focus on PTX effects, excluding those with cognitive impairments, ongoing experimental drug trials, documented PTX intolerance/allergy, contraindicated medications, or males.

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.


Eligibility criteria: 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 outcomes:
measure: Identification of Body Composition Parameter (Muscle mass) Related to Dose-Limiting Toxicities (DLTs)
timeFrame: 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).
measure: Identification of Body Composition Parameters (Fat %) Related to Dose-Limiting Toxicities (DLTs)
timeFrame: 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).
measure: Identification of Physical Activity Parameters Related to Dose-Limiting Toxicities (DLTs)
timeFrame: 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).
Secondary outcomes:
measure: Paclitaxel Exposure Analysis (Cmax)
timeFrame: 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.
measure: Paclitaxel Exposure Analysis (AUC)
timeFrame: 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.
measure: Number and Type of Dose-Limiting Toxicities
timeFrame: DLTs recorded the week following paclitaxel infusion cycles 1, 6, 9, and 12 (each cycle is 7 days).
Other outcomes:
measure: Treatment-Related Adverse Events
timeFrame: During the whole treatment (12 cycles, each cycle is 7 days) and 7 days post-treatment.
measure: Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (muscle mass)
timeFrame: BIA assessments are scheduled at baseline (prior to the start of paclitaxel treatment), cycle 6 (week 6), and cycle 12 (week 12). Each cycle is 7 days.
measure: Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (fat %)
timeFrame: BIA assessments are scheduled at baseline (prior to the start of paclitaxel treatment), cycle 6 (week 6), and cycle 12 (week 12). Each cycle is 7 days.
measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (muscle mass)
timeFrame: DEXA scans are conducted at baseline (prior to the start of paclitaxel treatment), cycle 6 (week 6), and cycle 12 (week 12). Each cycle is 7 days.
measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (fat mass)
timeFrame: DEXA scans are conducted at baseline (prior to the start of paclitaxel treatment), cycle 6 (week 6), and cycle 12 (week 12). Each cycle is 7 days.
measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (extracellular fluid)
timeFrame: DEXA scans are conducted at baseline (prior to the start of paclitaxel treatment), cycle 6 (week 6), and cycle 12 (week 12). Each cycle is 7 days.
measure: The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)
timeFrame: Administered at baseline (prior to the start of paclitaxel treatment), and after cycles 6 (week 6), 9 (week 9), and 12 (week 12). Each cycle is 7 days.
measure: EORTC QLQ-BR45 Breast (BR) Cancer Module
timeFrame: Completed alongside the QLQ-C30 at baseline, and following cycles 6, 9, and 12. Each cycle is 7 days.
measure: EORTC QLQ- Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20
timeFrame: This questionnaire is administered at baseline, and following cycles 6, 9, and 12. Each cycle is 7 days.
measure: European Health Interview Survey Physical Activity Questionnaire (EHIS PAQ)
timeFrame: Physical activity is monitored for 7 days following paclitaxel infusion cycles 1, 6, 9, and 12. Each cycle is 7 days.
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
state: Jette
city: Brussel
country: Belgium
facility: Vrije Universiteit Brussel
state: Jette
Study officials:
affiliation: Vrije Universiteit Brussel
name: Nele Adriaenssens, PhD
role: PRINCIPAL_INVESTIGATOR
References: