Liver Cancer Prevention Randomized Control Trial

Last updated: February 20, 2026
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hyponatremia

Primary Biliary Cholangitis

Hepatic Fibrosis

Treatment

Control Group

Intervention Group

Clinical Study ID

NCT05196867
2021-1015
NCI-2021-14391
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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:

  2. Waist circumference ≥90/80 cm in Asians or ≥102/88 cm in other racial groups)

  3. Blood pressure ≥130/85 mmHg or specific drug treatment

  4. Plasma triglycerides ≥150 mg/dl or specific drug treatment

  5. Plasma HDL-cholesterol <40 mg/dl for men and <50 mg/dl for women, or specific drugtreatment

  6. 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:

  1. chronic HBV (HBsAg+ or taking anti-HBV therapy), or

  2. chronic HCV (1. detectable HCV RNA > 4 months or a 2. history of HCV infection andtaking anti-HCV therapy)

  3. At least 18 years old 4. Speak and read English or Spanish 5. Access tosmartphone with data plan or Wi-Fi access 6. Willing to receive up to 12 textmessages per week

Exclusion

Exclusion Criteria:

  1. Pregnant or planning to become pregnant in next 12 months (by self-report)

  2. Medical contraindications to home-based exercise or low-fat,high-vegetable-and-fruit diet

  3. Recent or planned surgery that would interfere with home-based exercise or alow-fat, high vegetable and fruit diet

  4. Current or prior history of primary liver cancer or cancer that is metastaticto the liver

  5. AUDIT-10 score >15

  6. Family or household member already enrolled into study

Study Design

Total Participants: 49
Treatment Group(s): 2
Primary Treatment: Control Group
Phase:
Study Start date:
February 11, 2022
Estimated Completion Date:
August 30, 2028

Study Description

Hypothesis: A technology-assisted self-management intervention that addresses diet, physical activity, alcohol use, and medication adherence can produce regression in fibrosis as measured by FIB-4 in patients with fibrosis or steatosis and risk factors for cirrhosis, including chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, alcohol use, or non-alcoholic fatty liver disease (NAFLD).

Primary objective:

To test the effect of the behavioral intervention on fibrosis in a randomized trial. We will randomize eligible HOPE Clinic patients to (i) a 6-month self-management intervention to help participants implement behavioral changes to manage their disease or (ii) a wait-list control group that will receive the intervention after their 6-month assessment.

Secondary objective:

Evaluate changes in behavioral risk factors for liver fibrosis or steatosis (body composition, physical activity, diet, medication adherence, alcohol use), metabolic syndrome, and patient activation and other behavioral determinants.

Connect with a study center

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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