Liver Cancer Prevention Randomized Control Trial

Running, not enrolling · Not applicable

Conditions studied: Liver Diseases, Fibrosis, Liver, Cirrhosis, Liver

In brief

To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis.

Key facts

Study ID

NCT05196867

Run by

M.D. Anderson Cancer Center

People needed

49

Starts

2022-02-11

Expected to finish

2028-08-30

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Evidence of steatosis (CAP score ≥ 290 by vibration controlled transient elastography) OR Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography [F2 score ≥ 8kPa]) AND meets one of the following criteria: i. overweight or obese (BMI≥23 in Asians or BMI≥25 in other racial groups), OR ii. presence of type II diabetes mellitus, OR iii. lean/normal weight with presence of at least two metabolic risk abnormalities, OR:
• Waist circumference ≥90/80 cm in Asians or ≥102/88 cm in other racial groups)
• Blood pressure ≥130/85 mmHg or specific drug treatment
• Plasma triglycerides ≥150 mg/dl or specific drug treatment
• Plasma HDL-cholesterol <40 mg/dl for men and <50 mg/dl for women, or specific drug treatment
• Prediabetes (fasting glucose levels 100-125 mg/dl , or HbA1c 5.7-6.4% ) iv. AUDIT-C ≥4 for men and ≥3 for women AND AUDIT-10 = 8-15
• AND/OR 2. Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography) and presence of one of the following:
• chronic HBV (HBsAg+ or taking anti-HBV therapy), or
• chronic HCV (1. detectable HCV RNA > 4 months or a 2. history of HCV infection and taking anti-HCV therapy)
• At least 18 years old 4. Speak and read English or Spanish 5. Access to smartphone with data plan or Wi-Fi access 6. Willing to receive up to 12 text messages per week

You may not qualify if…

• Pregnant or planning to become pregnant in next 12 months (by self-report)
• Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet
• Recent or planned surgery that would interfere with home-based exercise or a low-fat, high vegetable and fruit diet
• Current or prior history of primary liver cancer or cancer that is metastatic to the liver
• AUDIT-10 score >15
• Family or household member already enrolled into study

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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