Back to results

Liver Cancer Prevention Randomized Control Trial

Primary Purpose

Liver Diseases, Fibrosis, Liver, Cirrhosis, Liver

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intervention Group

Control Group

About this trial

This is an interventional prevention trial for Liver Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Evidence of liver fibrosis (Liver fibrosis serum biomarker (FIB-4) index > 1.3 or Liver fibrosis grade > F2 by fibroscan) or hepatic steatosis (CAP score > 290) 2. Presence of at least 1 risk factor for cirrhosis:

a. chronic HBV (HBsAg+ or taking anti-HBV therapy) b. chronic HCV (HCV RNA detectable or taking anti-HCV therapy) c. Meets metabolic criteria for metabolic dysfunction-associated fatty liver disease (MAFLD) i. overweight or obese (BMI≥23 in Asians or BMI≥25 in other racial groups), ii. presence of type II diabetes mellitus iii. presence of at least two metabolic risk abnormalities

1. Waist circumference >90/80cm 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 (>1.70 mmol/L) or specific drug treatment 4. Plasma HDL-cholesterol <40 mg/dl (<1.0 mmol/L) for men and <50 mg/dl (<1.3 mmol/L) for women or specific drug treatment 5. Prediabetes (fasting glucose levels 100-125 mg/dl [5.6-6.9 mmol/L], or 2-hour post-load glucose levels 140-199 mg/dl [7.8-11.0 mmol] or HbA1c 5.7%-6.4% [39-47 mmol/mol])

d. AUDIT-C >4 for men and >3 for women AND AUDIT-10 = 8-15 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:

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

Sites / Locations

MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1: Immediate Intervention

Arm 2: Delayed Intervention

Arm Description

participants will receive the 6 months intervention immediately

participants will receive the intervention after the 6-month follow-up visit

Outcomes

Primary Outcome Measures

Change in FIB-4 score

a serum-based biomarker of fibrosis

Secondary Outcome Measures

Full Information

NCT ID

NCT05196867

First Posted

December 29, 2021

Last Updated

September 14, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

Cancer Prevention Research Institute of Texas

1. Study Identification

Unique Protocol Identification Number

NCT05196867

Brief Title

Liver Cancer Prevention Randomized Control Trial

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 11, 2022 (Actual)

Primary Completion Date

August 30, 2024 (Anticipated)

Study Completion Date

August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

Cancer Prevention Research Institute of Texas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Diseases, Fibrosis, Liver, Cirrhosis, Liver

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Immediate Intervention

Arm Type

Experimental

Arm Description

participants will receive the 6 months intervention immediately

Arm Title

Arm 2: Delayed Intervention

Arm Type

Experimental

Arm Description

participants will receive the intervention after the 6-month follow-up visit

Intervention Type

Behavioral

Intervention Name(s)

Intervention Group

Intervention Description

Participants in the intervention group will receive (1) weekly telephone or videoconference coaching; (2) health education print materials and tip sheets;(3) navigation to programs and resources to help participants meet behavioral goals (e.g., fitness events, classes and webinars, etc); (4) text messages related to behavioral skills; (5) a Fitbit activity tracker and Aria scale; (6) resistance tubes and instructional video for strengthening exercise (if resistance exercise module is chosen); and (7) tools to manage portion sizes.

Intervention Type

Behavioral

Intervention Name(s)

Control Group

Intervention Description

Patients in the control arm will initially receive written education material about the risk factors for liver cancer and management options. They will be offered the intervention after they complete the 6-month assessment.

Primary Outcome Measure Information:

Title

Change in FIB-4 score

Description

a serum-based biomarker of fibrosis

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Evidence of liver fibrosis (Liver fibrosis serum biomarker (FIB-4) index > 1.3 or Liver fibrosis grade > F2 by fibroscan) or hepatic steatosis (CAP score > 290) 2. Presence of at least 1 risk factor for cirrhosis: a. chronic HBV (HBsAg+ or taking anti-HBV therapy) b. chronic HCV (HCV RNA detectable or taking anti-HCV therapy) c. Meets metabolic criteria for metabolic dysfunction-associated fatty liver disease (MAFLD) i. overweight or obese (BMI≥23 in Asians or BMI≥25 in other racial groups), ii. presence of type II diabetes mellitus iii. presence of at least two metabolic risk abnormalities 1. Waist circumference >90/80cm 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 (>1.70 mmol/L) or specific drug treatment 4. Plasma HDL-cholesterol <40 mg/dl (<1.0 mmol/L) for men and <50 mg/dl (<1.3 mmol/L) for women or specific drug treatment 5. Prediabetes (fasting glucose levels 100-125 mg/dl [5.6-6.9 mmol/L], or 2-hour post-load glucose levels 140-199 mg/dl [7.8-11.0 mmol] or HbA1c 5.7%-6.4% [39-47 mmol/mol]) d. AUDIT-C >4 for men and >3 for women AND AUDIT-10 = 8-15 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: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karen Basen-Engquist, MD

Phone

713) 745-3123

kbasenen@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Basen-Engquist

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Basen-Engquist, MD

Phone

713-745-3123

kbasenen@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Karen Basen-Engquist, MD

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

M D Anderson Cancer Center

Learn more about this trial

Liver Cancer Prevention Randomized Control Trial

We'll reach out to this number within 24 hrs