Clinical trial · Observational
Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epirubicin-cyclophosphamide | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Epirubicin-cyclophosphamide
- description
- Woman with early breast cancer receiving a first cycle of epirubicin-cyclphosphamide
- interventionNames
- Drug: Epirubicin-cyclophosphamide
- label
- Paclitaxel
- description
- Woman with early breast cancer receiving a first cycle of paclitaxel
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Investigate the acute effect of chemotherapy administration on protein turnover cellular processes through vastus lateralis biopsies of breast cancer patients
- timeFrame
- Before and 4 days after the chemotherapy
- description
- Change From Baseline in Western Blots measurements of protein expression levels
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available