Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients (PROTECT-05)

This is a monocentric, prospective and interventional study aimed to investigating the physiological responses of eccentric compared to concentric cycling realized 1) at the same metabolic demand and 2) at the same mechanical power output. In order to compare the physiological responses between these two cycling modalities, 3 cycling sessions should be performed for each patient where concentric one will serve as reference / comparison to the eccentric one:

• Session (a): eccentric cycling
• Session (b): high intensity concentric cycling realized at the same mechanical power output than eccentric cycling
• Session (c): low intensity concentric cycling realized at the same metabolic demand than eccentric cycling The 3 sessions will be performed for each patient and order will be randomized.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Session (a); Other: Session (b); Other: Session (c)

Detailed Description

For each participant, 10 visits will be realized as followed:

Visit 1: determination of maximal O2 consumption (VO2max) and first familiarization session to eccentric cycling Visits 2, 3 and 4: second, third and fourth eccentric cycling familiarization sessions Visits 5, 7 and 9: cycling sessions (a), (b) and (c) attributed in a random order Visits 6, 8 and 10: post-24h measurements after cycling sessions

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France
    • Institut de cancerologie Strasbourg Europe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Woman who completed (neo)adjuvant chemotherapy since less than 1 year for a breast cancer
• Woman under hormonotherapy, or menopausal woman, or woman in amenorrhea

Exclusion Criteria:

• Pregnant and nursing woman
• psychiatric, musculoskeletal or neurological disorders
• presenting at least one contraindication to the use of the transcranial magnetic stimulation
• presenting at least one contraindication to the realisation of the maximum effort test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eccentric cycling compared to concentric cycling; Every participant will perform the same protocol and will participated to the 3 experimental sessions (a, b and c) of the assigned intervention.	Other: Session (a); Eccentric cycling; Other: Session (b); High intensity concentric cycling realized at the same mechanical power output than eccentric cycling; Other: Session (c); Low intensity concentric cycling realized at the same metabolic demand than eccentric cycling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate the physiological responses of the eccentric cycling on the knee extensors muscles by changes of neuromuscular parameters	Measurement of neuromuscular fatigue via change in maximal voluntary isometric contraction of the knee extensors muscles registered via a force sensor.	24 hours after pedaling sessions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of muscle pain after eccentric in session (a) and after concentric modalities in session (b) and session (c)	Measurement of muscle pain by visual analog scale (VAS) consists of a 100 mm long line providing a range of score from 0-100 (0: no pain, 100: worst possible pain).	24 hours after pedaling sessions
Comparison of central (identified as a decrease in voluntary activation, VA) fatigue after eccentric in session (a) and after concentric modalities in session (b) and session (c)	Measurement of central fatigue by percutaneous neurostimulation applied during the maximal voluntary contraction to evidence the level of voluntary activation (VA in %) and by transcranial magnetic stimulation to evidenced level of corticospinal excitability (measured by the MEP visible on EMG activity).	24 hours after pedaling sessions
Comparison of peripheral (identified as a decrease in the quadriceps twitch muscle contractile capacities, Qtw) fatigue after eccentric in session (a) and after concentric modalities in session (b) and session (c)	Measurement of peripheral fatigue by percutaneous neurostimulation applied at rest to evoked quadriceps twitch force (Qtw) to evidence muscle contractile properties.	24 hours after pedaling sessions
Comparison of muscle thickness measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)	Change from baseline by ultrasonography measurements in the muscle thickness of the vastus lateralis muscle. Muscle thickness was measured as the distance from the superior border of the superficial aponeurosis and the superior border of the deep aponeurosis.	24 hours after pedaling sessions
Comparison of muscle fibers pennation angle measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)	Change from baseline by ultrasonography measurements in the pennation angle of the vastus lateralis muscle. Pennation angle was measured as the angle between a fiber and the deep aponeurosis.	24 hours after pedaling sessions
Comparison of muscle fibers fascile length measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)	Change from baseline by ultrasonography measurements in the fascicle length of the vastus lateralis muscle. Fascicle length was measured as the distance of a fibers between its insertion on the superficial aponeurosis and its insertions on the deep aponeurosis.	24 hours after pedaling sessions
Comparison of muscle echogenecity measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)	Change from baseline by ultrasonography measurements in echogenecity of the vastus lateralis muscle. Echo intensity was determined based on the gray scale analysis of each pixel, the corresponding index of muscle quality ranging between 0 and 255 arbitrary units.	24 hours after pedaling sessions
Comparison of blood markers in session (a) and after concentric modalities in session (b) and session (c)	Change from baseline of blood markers dosage. Blood markers dosage investigated will: Reactive oxygen species (ROS), carbonylated protein, lipid peroxidation, antioxidant enzyme, proinflammatory cytokines, and muscle damage markers (creatine kinase, lactate dehydrogenase).	24 hours after pedaling sessions

Collaborators and Investigators

• Sponsor: Institut de cancérologie Strasbourg Europe
• Investigators: Principal Investigator: Roland SCHOTT, MD, Institut de cancerologie Strasbourg Europe

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2021
• Primary Completion (Actual): April 28, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Eccentric Cycling; Physiological Responses
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2021-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No