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

NCT06387901 | Recruiting DMC

• 1 other identifier: PABTOX - part 1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (3)

• Identification 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.

  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.

  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.

  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 (3)

• 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.

• 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.

• 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).

Other Outcomes (10)

• Treatment-Related Adverse Events

  During the whole treatment (12 cycles, each cycle is 7 days) and 7 days post-treatment.

• Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (muscle mass)

  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.

• Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (fat %)

  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.

Study Arms (1)

Breast Cancer Patients on Paclitaxel

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

Drug: Paclitaxel Chemotherapy

Interventions

Paclitaxel Chemotherapy DRUG

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.

Breast Cancer Patients on Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator
• University Ghent: collaborator

Study Sites (2)

UZ Brussel

Brussels, Jette, 1090, Belgium

RECRUITING

Vrije Universiteit Brussel

Brussels, Jette, 1090, Belgium

NOT YET RECRUITING

Related Links

• Kom op Tegen Kanker project

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Breast Neoplasms; Body Weight; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Nele Adriaenssens, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Len De Nys

CONTACT

+32 472 99 49 48; Len.de.nys@vub.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 29, 2024
• Study Start: July 30, 2024
• Primary Completion: May 6, 2025
• Study Completion: October 31, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

BE (2)