Liver Cancer Prevention Randomized Control Trial

Launched by M.D. ANDERSON CANCER CENTER · Jan 18, 2022

Keywords

ClinConnect Summary

This clinical trial is designed to study a special program aimed at helping people with certain liver conditions, like fibrosis or steatosis, manage their health better and potentially prevent serious problems like cirrhosis. The researchers want to see if this program, which includes personalized support and guidance, can make a difference in the lives of patients who are at risk. If you are between the ages of 65 and 74 and have signs of liver issues along with other health factors—like being overweight, having diabetes, or other metabolic concerns—you might be eligible to join.

Participants in this study can expect to receive up to 12 text messages a week, providing support and encouragement for healthier lifestyle choices, such as diet and exercise. It's important to note that you need to be comfortable using a smartphone and able to read either English or Spanish. However, if you are pregnant, have certain medical conditions, or have a history of liver cancer, you wouldn’t be able to participate. This study offers a chance to take an active role in your health while contributing to valuable research that could help others in the future.

Gender

ALL

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