Liver Cancer Prevention Randomized Control Trial

Description

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

Conditions

Liver Diseases, Fibrosis, Liver, Cirrhosis, Liver

Study Overview

Study Details

Study overview

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

A Randomized, Prospective Study of a Behaviorally-based Tailored Disease Management Intervention Vs Control in Patients with Risk Factors for Liver Disease

Liver Cancer Prevention Randomized Control Trial

Condition
Liver Diseases
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 1. Waist circumference ≥90/80 cm in Asians or ≥102/88 cm in other racial groups)
  • 2. Blood pressure ≥130/85 mmHg or specific drug treatment
  • 3. Plasma triglycerides ≥150 mg/dl or specific drug treatment
  • 4. Plasma HDL-cholesterol \<40 mg/dl for men and \<50 mg/dl for women, or specific drug treatment
  • 5. 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
  • 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 and taking anti-HCV therapy)
  • 3. 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
  • 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 a low-fat, high vegetable and fruit diet
  • 4. Current or prior history of primary liver cancer or cancer that is metastatic to the liver
  • 5. AUDIT-10 score \>15
  • 6. Family or household member already enrolled into study

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Karen Basen-Engquist, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2025-08-30