Behavioral intervention for liver cancer prevention

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

This study is testing a new program that helps people with liver issues change their diet, exercise, and habits to see if it can lower their risk of liver cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 266 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05196867 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a technology-assisted self-management intervention designed to help patients with fibrosis or steatosis and risk factors for cirrhosis. Participants will be randomized into two groups: one receiving a 6-month tailored intervention focusing on diet, physical activity, alcohol use, and medication adherence, and a control group that will receive the intervention after a 6-month wait. The primary objective is to assess changes in liver fibrosis as measured by the FIB-4 index, while secondary objectives include evaluating changes in behavioral risk factors and metabolic syndrome. The study is conducted at the MD Anderson Cancer Center in Houston, Texas.

Who should consider this trial

Good fit: Ideal candidates include individuals with evidence of liver fibrosis or steatosis and specific risk factors such as obesity, type II diabetes, or metabolic abnormalities.

Not a fit: Patients without evidence of liver fibrosis or steatosis, or those not meeting the specified risk criteria, may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this intervention could lead to significant regression of liver fibrosis and improved management of liver health in at-risk patients.

How similar studies have performed: Other studies have shown promise in using behavioral interventions for managing liver diseases, indicating potential for success in this approach.

Eligibility criteria

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:

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

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 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

   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 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

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Karen Basen-Engquist, MD — M.D. Anderson Cancer Center
• Study coordinator: Karen Basen-Engquist, MD

Conditions Liver Diseases; Fibrosis, Liver; Cirrhosis, Liver