RECRUITING

To Test Whether Time-restricted Eating Coupled With a Healthy Diet is Beneficial in Liver Cancer Patients

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Conditions

Liver Cancer, AdultMASH - Metabolic Dysfunction-Associated SteatohepatitisObesity and OverweightTime-restricted eatinghealthy diet

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a feasibility study that will collect data to assess the potential effect of a nutritional intervention designed to improve liver metabolism. This prospective single-site trial will enroll adult patients undergoing liver-directed therapies for hepatocellular carcinoma. Eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating in which calorie consumption is limited to 8-10 hours during the day, plus targeted healthy changes in what they eat. The intervention includes dietary counseling visits with a study registered dietitian and motivational phone calls with a study Certified Health and Wellness Coach to help subjects adhere to the intervention. Individuals in the control group will be enrolled in a six-month period of observation only. The main questions it aims to answer are: Is a prolonged nightly fast coupled with a healthy diet safe and feasible for patients with liver cancer? Does the intervention improve liver metabolism?

Official Title

Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma

Quick Facts

Study Start:2025-08
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06824974

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Overweight or obese (BMI 27-45 kg/m2)
  2. 2. BCLC early to intermediate stage HCC
  3. 3. Referred for liver-directed therapy (PTA, TACE, TARE within 3 months)
  4. 4. English or Spanish speaking over the age of 18.
  5. 5. ECOG Performance Status ≤ 2.
  6. 6. Usual nightly fasting \<12 hours
  7. 7. Willing to comply with all study procedures
  8. 8. Child-Pugh A liver function.
  1. 1. Advanced HCC, progression, and/or associated comorbidities, metastatic disease, tumor in vein, or ascites
  2. 2. Advanced Cirrhosis (hypoalbuminemia/Child-Pugh B+C). Poorly controlled or refractory (grade 3-4) hepatic encephalopathy
  3. 3. Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM
  4. 4. Participation in another conflicting study that requires modification of diet or food timing.
  5. 5. Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity)
  6. 6. Medications that markedly impact metabolic study biomarkers.
  7. 7. Other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)
  8. 8. Serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial.
  9. 9. Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy
  10. 10. Active alcohol abuse or less than 6 months of sobriety
  11. 11. Participation in a trial of an investigational agent within the prior 30 days
  12. 12. Pregnancy or lactating

Contacts and Locations

Study Contact

Nick Webster, PhD
CONTACT
858-534-6275
nwebster@health.ucsd.edu
Tanya Shekhtman
CONTACT
tshekhtman@health.ucsd.edu

Principal Investigator

Nick Webster, PhD
PRINCIPAL_INVESTIGATOR
Universoty of California San Diego

Study Locations (Sites)

University of California San Diego
La Jolla, California, 92093
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Nick Webster, PhD, PRINCIPAL_INVESTIGATOR, Universoty of California San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-08
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Time-restricted eating
  • healthy diet

Additional Relevant MeSH Terms

  • Liver Cancer, Adult
  • MASH - Metabolic Dysfunction-Associated Steatohepatitis
  • Obesity and Overweight