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NCT Number: NCT07189624

Effect of Acute Endurance Exercise on the Production of FGF21 and Follistatin in Patients With Hepatocellular Carcinoma

The main purpose of the study is to characterize the production of hepatokines (FGF21 and Follistatin) in response to a submaximal exercise on an ergocycle, in patients with hepatocellular carcinoma. The effect of exercise on hepatokines and metabolites production in liver cancer patients is not known. Studying this production could help to provide relevant recommendations for training programming in these patients.

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Key information

Conditions

Cirrhosis With Hepatocellular Carcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hepatocellular carcinoma developed on cirrhosis
  • Cirrhosis of any etiology, defined by a liver elasticity measurement >15kPa or a history of cirrhosis decompensation
  • Hepatocellular carcinoma with indication for treatment by immunotherapy or chemoembolization
  • Child-Pugh scores A and B7
  • WHO score ≤ 2
  • Affiliation to french national social security system

Exclusion criteria

  • Hepatic encephalopathy grade II or higher
  • Bone metastasis
  • Surgery performed within 30 days prior to inclusion visit
  • Liver transplant
  • Muscle injury within 3 months of inclusion
  • Pregnant or breast-feeding women
  • Patients under legal protection (guardianship, curatorship, safeguard of justice)
  • Participation in another clinical trial within 10 days of inclusion

Treatment and study plan

Exercise

Other

30-minutes exercise on a bicycle with heart rate monitor and gas exchange analyzer.

Primary outcomes

  1. Systemic hepatokines rates (FGF-21 and follistatin)

    Time frame: Baseline (pre-exercise), immediately after exercise, 1 hour after the end of exercise

    Blood samples

Secondary outcomes

  1. Muscle pain assessment

    Time frame: Baseline (pre-exercise), immediately after exercise, 1 hour after the end of exercise

    Visual analog scale. Score from 0 (total absence of muscle pain) to 10 (maximum muscle pain).

Other outcomes

  1. Fatigue assessment

    Time frame: Baseline (pre-exercise), immediately after exercise, 1 hour after the end of exercise

    Visual analog scale. Score from 0 (total absence of fatigue) to 10 (maximum fatigue).

  2. Perception of effort assessment

    Time frame: Baseline (at the beginning), periprocedural (middle of exercise), immediately after exercise

    Borg scale

  3. Production of metabolites

    Time frame: Baseline (pre-exercise), immediately after exercise, 1 hour after the end of exercise

    Blood samples

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

0473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: ECHEF

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 24, 2025
Registry last updated
Dec 31, 2025

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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