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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Microbiopsy sample
Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
Sponsored by
Institut de cancérologie Strasbourg Europe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut de Cancerologie Strasbourg Europe

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 1 without trastuzumab

Group 2 with trastuzumab

Arm Description

Outcomes

Primary Outcome Measures

Change in vastus lateralis cross-sectional area
Measured from muscle microbiopsy sample

Secondary Outcome Measures

Alteration of patients body composition
Assessment using bio-impedance analysis
Alteration of patients strength
Assessment of maximal isometric muscle strength for knee extensors measured with force sensors.
Alteration of patients muscle architecture
Assessment using muscle ultrasonography
Alteration of patients quality of life
Self-assessment questionnaire Functional Assessment of Cancer Therapy - General (FACT-G) (version 3)
Evaluation of patient cachexia
Questionnaire Functional Assessment of Anorexia/Cachexia Therapy (FAACT) (version 4)

Full Information

First Posted
November 2, 2020
Last Updated
February 7, 2023
Sponsor
Institut de cancérologie Strasbourg Europe
Collaborators
UR 3072 - Mitochondries, Stress oxydant, Protection musculaire
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1. Study Identification

Unique Protocol Identification Number
NCT04638712
Brief Title
Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients
Acronym
PROTECT-03
Official Title
Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
May 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de cancérologie Strasbourg Europe
Collaborators
UR 3072 - Mitochondries, Stress oxydant, Protection musculaire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 without trastuzumab
Arm Type
Other
Arm Title
Group 2 with trastuzumab
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Microbiopsy sample
Intervention Description
before and after chemotherapy
Intervention Type
Other
Intervention Name(s)
Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
Intervention Description
before and after chemotherapy
Primary Outcome Measure Information:
Title
Change in vastus lateralis cross-sectional area
Description
Measured from muscle microbiopsy sample
Time Frame
Between Week 18 and 24 after chemotherapy
Secondary Outcome Measure Information:
Title
Alteration of patients body composition
Description
Assessment using bio-impedance analysis
Time Frame
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Title
Alteration of patients strength
Description
Assessment of maximal isometric muscle strength for knee extensors measured with force sensors.
Time Frame
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Title
Alteration of patients muscle architecture
Description
Assessment using muscle ultrasonography
Time Frame
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Title
Alteration of patients quality of life
Description
Self-assessment questionnaire Functional Assessment of Cancer Therapy - General (FACT-G) (version 3)
Time Frame
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Title
Evaluation of patient cachexia
Description
Questionnaire Functional Assessment of Anorexia/Cachexia Therapy (FAACT) (version 4)
Time Frame
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institut de Cancerologie Strasbourg Europe
City
Strasbourg
ZIP/Postal Code
67033
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34595171
Citation
Mallard J, Hucteau E, Hureau TJ, Pagano AF. Skeletal Muscle Deconditioning in Breast Cancer Patients Undergoing Chemotherapy: Current Knowledge and Insights From Other Cancers. Front Cell Dev Biol. 2021 Sep 14;9:719643. doi: 10.3389/fcell.2021.719643. eCollection 2021.
Results Reference
result
PubMed Identifier
35373507
Citation
Mallard J, Hucteau E, Charles AL, Bender L, Baeza C, Pelissie M, Trensz P, Pflumio C, Kalish-Weindling M, Geny B, Schott R, Favret F, Pivot X, Hureau TJ, Pagano AF. Chemotherapy impairs skeletal muscle mitochondrial homeostasis in early breast cancer patients. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1896-1907. doi: 10.1002/jcsm.12991. Epub 2022 Apr 4.
Results Reference
result
PubMed Identifier
36094434
Citation
Mallard J, Hucteau E, Bender L, Charlot A, Debrut L, Pflumio C, Trensz P, Schott R, Favret F, Pivot X, Hureau TJ, Pagano AF. Development of skeletal muscle atrophy and intermuscular adipose tissue in patients with early breast cancer treated with chemotherapy. Am J Physiol Cell Physiol. 2022 Oct 1;323(4):C1325-C1332. doi: 10.1152/ajpcell.00373.2022. Epub 2022 Sep 12.
Results Reference
result

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

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