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

Institut de cancérologie Strasbourg Europe

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Epirubicin-cyclophosphamide; Drug: Paclitaxel

Study type: Observational

Funder types: Other

Identifiers

NCT05128617

2021-004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Epirubicin-cyclophosphamide

Description:

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

Treatment:

Drug: Epirubicin-cyclophosphamide

Paclitaxel

Description:

Woman with early breast cancer receiving a first cycle of paclitaxel

Treatment:

Drug: Paclitaxel