Status:
ACTIVE_NOT_RECRUITING
Liver Cancer Prevention Randomized Control Trial
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Cancer Prevention Research Institute of Texas
Conditions:
Liver Diseases
Fibrosis, Liver
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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:
- 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)
- 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
- 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
Key Trial Info
Start Date :
February 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2025
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT05196867
Start Date
February 11 2022
End Date
August 30 2025
Last Update
August 29 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030