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Completed

NCT Number: NCT04638712

Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients

This is an interventional, prospective and monocentric study. This study includes the evaluation before and after (neo)adjuvant therapy of :

* one group of patients receiving anthracyclines and taxanes * a second group of patients receiving anthracyclines, taxanes and trastuzumab.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie Strasbourg Europe

Strasbourg, 67033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For group 1 without trastuzumab :

  • Patients must be ≥ 18 years old
  • Patients with breast cancer stage I to III
  • Patients who will receive (neo)adjuvant anthracyclines and weekly taxane, without trastuzumab
  • Patients must have a social security coverage
  • Patients able to speak, read and understand French

For group 2 with trastuzumab :

  • Patients must be ≥ 18 years old
  • Patients with breast cancer grade I to III
  • Patients who will receive (neo)adjuvant anthracyclines and weekly taxane, with trastuzumab
  • Patients must have a social security coverage
  • Patients able to speak, read and understand French

Exclusion criteria

  • History of cancer
  • Previous chemotherapy
  • Patients with known chronic pathology (musculoskeletal disorders, autoimmune, vascular or neuromuscular disease)
  • Pacemaker implantation
  • Contraindication to physical condition evaluation
  • Contraindication to local anesthesia required for microbiopsy
  • Patients < 18 years old or patients ≥ 18 years old under guardianship, or supervision
  • Psychiatric, musculoskeletal or neurologic disorders
  • Women that are pregnant or breast-feeding

Treatment and study plan

Microbiopsy sample

Other

before and after chemotherapy

Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level

Other

before and after chemotherapy

Primary outcomes

  1. Change in vastus lateralis cross-sectional area

    Time frame: Between Week 18 and 24 after chemotherapy

    Measured from muscle microbiopsy sample

Secondary outcomes

  1. Alteration of patients body composition

    Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)

    Assessment using bio-impedance analysis

  2. Alteration of patients strength

    Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)

    Assessment of maximal isometric muscle strength for knee extensors measured with force sensors.

  3. Alteration of patients muscle architecture

    Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)

    Assessment using muscle ultrasonography

  4. Alteration of patients quality of life

    Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)

    Self-assessment questionnaire Functional Assessment of Cancer Therapy - General (FACT-G) (version 3)

  5. Evaluation of patient cachexia

    Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)

    Questionnaire Functional Assessment of Anorexia/Cachexia Therapy (FAACT) (version 4)

Sponsors and collaborators

Lead sponsor

Institut de cancérologie Strasbourg Europe

Other

Collaborators

  • UR 3072 - Mitochondries, Stress oxydant, Protection musculaire

Registry information

Acronym: PROTECT-03

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2020
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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