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

University Hospital, Clermont-Ferrand

Status: Not yet enrolling

Conditions: Cirrhosis With Hepatocellular Carcinoma

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07189624

RBHP 2024 ABERGEL

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Single arm

Experimental group

Description:

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.

Treatment:

Other: Exercise