This study is not yet accepting patients

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

a study on Liver Cancer Steatohepatitis Obesity Hepatocellular Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California
Dates
study started
completion around
Principal Investigator
by Nick Webster, Ph.D., M.A.

Description

Summary

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

Keywords

Liver Cancer, Adult, MASH - Metabolic Dysfunction-Associated Steatohepatitis, Obesity and Overweight, Time-restricted eating, healthy diet, Liver Neoplasms, Hepatocellular Carcinoma, Fatty Liver, Overweight, Time-restricted eating plus healthy diet

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Overweight or obese (BMI 27-45 kg/m2)
  2. BCLC early to intermediate stage HCC
  3. Referred for liver-directed therapy (PTA, TACE, TARE within 3 months)
  4. English or Spanish speaking over the age of 18.
  5. ECOG Performance Status ≤ 2.
  6. Usual nightly fasting <12 hours
  7. Willing to comply with all study procedures
  8. Child-Pugh A liver function.

You CAN'T join if...

  1. Advanced HCC, progression, and/or associated comorbidities, metastatic disease, tumor in vein, or ascites
  2. Advanced Cirrhosis (hypoalbuminemia/Child-Pugh B+C). Poorly controlled or refractory (grade 3-4) hepatic encephalopathy
  3. Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM
  4. Participation in another conflicting study that requires modification of diet or food timing.
  5. Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity)
  6. Medications that markedly impact metabolic study biomarkers.
  7. Other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)
  8. Serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial.
  9. Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy
  10. Active alcohol abuse or less than 6 months of sobriety
  11. Participation in a trial of an investigational agent within the prior 30 days
  12. Pregnancy or lactating

Location

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

Lead Scientist at UCSD

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06824974
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated