NCT05128617

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 4, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

October 4, 2021

Last Update Submit

June 7, 2023

Conditions

Breast Cancer

Keywords

Protein turnoverSkeletal muscle deconditoningBreast cancerChemotherapyMuscle biopsy

Outcome Measures

Primary Outcomes (1)

  • Investigate the acute effect of chemotherapy administration on protein turnover cellular processes through vastus lateralis biopsies of breast cancer patients

    Change From Baseline in Western Blots measurements of protein expression levels

    Before and 4 days after the chemotherapy

Secondary Outcomes (14)

  • Investigate the acute effect of chemotherapy administration on structural alterations

    Before and 4 days after the chemotherapy

  • Investigate the acute effect of chemotherapy administration on inflammation

    Before and 4 days after the chemotherapy

  • Investigate the acute effect of chemotherapy administration on mitochondrial homeostasis

    Before and 4 days after the chemotherapy

  • Investigate the acute effect of chemotherapy administration on fatty infiltrations

    Before and 4 days after the chemotherapy

  • Investigate the acute effect of chemotherapy administration on satellite cells

    Before and 4 days after the chemotherapy

  • +9 more secondary outcomes

Study Arms (2)

Epirubicin-cyclophosphamide

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

Drug: Epirubicin-cyclophosphamide

Paclitaxel

Woman with early breast cancer receiving a first cycle of paclitaxel

Drug: Paclitaxel

Interventions

Epirubicin-cyclophosphamideDRUG

1 cycle of Epirubicin-cyclophosphamide

Also known as: Epirubicin-endoxan
Epirubicin-cyclophosphamide
PaclitaxelDRUG

1 cycle of Paclitaxel

Also known as: Taxol
Paclitaxel

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Woman recieving the first administration of epirubicin-cyclophosphamide (group 1) or paclitaxel (group 2) for early breast cancer treatment

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancerologie Strasbourg Europe

Strasbourg, 67033, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

muscle micro-biopsy

MeSH Terms

Conditions

Breast Neoplasms

Interventions

EC regimenPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

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

Study Record Dates

First Submitted

October 4, 2021

First Posted

November 22, 2021

Study Start

November 4, 2021

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

June 8, 2023

Record last verified: 2023-06

Locations

FR(1)