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PROTECT-03: Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients

Sponsor
Institut de cancérologie Strasbourg Europe (Other)
Overall Status
Completed
CT.gov ID
NCT04638712
Collaborator
UR 3072 - Mitochondries, Stress oxydant, Protection musculaire (Other)
13
Enrollment
1
Location
2
Arms
8.1
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Microbiopsy sample
  • Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients
Actual Study Start Date :
Sep 16, 2020
Actual Primary Completion Date :
May 20, 2021
Actual Study Completion Date :
May 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Group 1 without trastuzumab

Other: Microbiopsy sample
before and after chemotherapy

Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
before and after chemotherapy
Other: Group 2 with trastuzumab

Other: Microbiopsy sample
before and after chemotherapy

Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
before and after chemotherapy

Outcome Measures

Primary Outcome Measures

  1. Change in vastus lateralis cross-sectional area [Between Week 18 and 24 after chemotherapy]

    Measured from muscle microbiopsy sample

Secondary Outcome Measures

  1. Alteration of patients body composition [Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)]

    Assessment using bio-impedance analysis

  2. Alteration of patients strength [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 [Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)]

    Assessment using muscle ultrasonography

  4. Alteration of patients quality of life [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 [Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut de Cancerologie Strasbourg Europe Strasbourg France 67033

Sponsors and Collaborators

  • Institut de cancérologie Strasbourg Europe
  • UR 3072 - Mitochondries, Stress oxydant, Protection musculaire

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut de cancérologie Strasbourg Europe
ClinicalTrials.gov Identifier:
NCT04638712
Other Study ID Numbers:
  • 2020-006
  • 2020-A01266-33
First Posted:
Nov 20, 2020
Last Update Posted:
Jun 8, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Jun 8, 2021