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

NCT ID: NCT07189624

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2029-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cirrhosis With Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single arm

A single study visit will be required, during which the following will be caried out:

* an assessment of physical condition: lower limb isometric strength test, liver frailty index, short physical performance battery, ultrasound assessment of quadriceps muscle mass
* a 30-minutes exercise session on a bicycle (with heart rate monitor and gas exchange analyzer)
* 3 fasting blood tests (before, at the end and 1 hour after the exercise) to assess the production of hepatokines and metabolites
* measurements of perceived fatigue, muscle pain and effort (before, at the end and 1 hour after the exercise).

Snacks will be served afterwards.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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

Interventions

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Exercise

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Estaing Medecine Digestive Et Hepatobiliaire

Clermont-Ferrand, , France

Site Status

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Central Contacts

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Lise Laclautre

Role: CONTACT

Phone: 0473754963

Email: [email protected]

Facility Contacts

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ARMANDO ABERGEL

Role: primary

lise Laclautre

Role: primary

Other Identifiers

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RBHP 2024 ABERGEL

Identifier Type: -

Identifier Source: org_study_id