Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-04

Study Completion Date

2023-05-30

Brief Summary

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Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue. Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients.

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Detailed Description

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Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. Resulting from a global perturbation of the muscle homeostasis, skeletal muscle is characterized by both structural and functional alterations that will translate into a decrease in muscle mass and/or force as well as an increase in muscle fatigability. These maladaptations result in a reduced quality of life and an increased treatment-related toxicity, ultimately leading to an increased mortality risk.To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue.Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients. Our study will particularly explore cellular mechanisms of muscle decontioning, such as protein turnover, mitochondrial homeostasis and fatty infiltrations.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Epirubicin-cyclophosphamide

Woman with early breast cancer receiving a first cycle of epirubicin-cyclphosphamide

Epirubicin-cyclophosphamide

Intervention Type DRUG

1 cycle of Epirubicin-cyclophosphamide

Paclitaxel

Woman with early breast cancer receiving a first cycle of paclitaxel

Paclitaxel

Intervention Type DRUG

1 cycle of Paclitaxel

Interventions

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Epirubicin-cyclophosphamide

1 cycle of Epirubicin-cyclophosphamide

Intervention Type DRUG

Paclitaxel

1 cycle of Paclitaxel

Intervention Type DRUG

Other Intervention Names

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Epirubicin-endoxan Taxol

Eligibility Criteria

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Inclusion Criteria

* Breast cancer (stade I to III)
* Patient recieving the first administration of epirubicin-cyclophosphamide (group 1) or paclitaxel (group 2) for early breast cancer treatment

Exclusion Criteria

* History of cancer
* Known chronic pathology
* Pacemaker
* Contraindication to the evaluation of the physical condition
* Contraindication to the local anesthesia for the muscle micro-biopsy
* Breastfeeding or pregnant woman

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No