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

University of California, San Diego50 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Liver Cancer, Adult MASH - Metabolic Dysfunction-Associated Steatohepatitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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. Exclusion Criteria: 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

Outcomes

Primary Outcomes

Adherence to protocol

Participant adherence to and comprehension of the protocol as an indicator of intervention delivery by staff. Adherence will be assessed by the number of participants who complete the study, the percentage of days with fasting \>14 h, and the number of days that food was logged into the app.

Time frame: 6 months

Safety from adverse events

Safety assessed by adverse events and liver function tests. Reports on adverse events will include hypoglycemic epidoes, nausea, disrupted sleep, decreased quality of life or other patient reported events from surveys. Liver function tests (AST and ALT) as well ss platelet count and total protein are monitored under SOC. AST and ALT elevation will be considered mild if 2-5 times upper limit normal (ULN), moderate if 5-15 times ULN, and severe if \>15 times ULN.

Time frame: 6 months

Ability to recruit

Ability to recruit our target population will be assessed by the number of eligible individuals in the patient population, and the number who enroll in the trial.

Time frame: 6 months

Satisfaction and self-motivation

We will determine the degree to which participants liked the intervention through satisfaction surveys at the end of the study and the number of participants who demonstrate self-motivation to continue the intervention protocol during 6-month follow-up.

Time frame: 6 months

Secondary Outcomes

Effect of intervention on Quality of Life

Quality of Life will be assessed using the EORTC QLQ C-30 questionnaire for Cancer patients

Time frame: 6 months

Effect of interventions on fasting glucose

Fasting glucose will be measured at baseline and 6 months

Time frame: 6-months

Sleep disturbance

Sleep disturbance as reported by the PROMIS-8b survey

Time frame: 6 months

Effect of intervention on body weight

Body weight will be measured prior to and during intervention

Time frame: 6 months

Effect of intervention on food frequency

Participants will complete a Food frequency questionnaire at Baseline, 3 months and 6 months

Time frame: 6 months

Effect of intervention on Adiposity

Adiposity will be measured by Dual-energy X-ray Absorptiometry (DXA) at baseline and at 6 months

Time frame: 6 months

Effect of interventions on Physical activity

Physical activity will be measured by Accelerometer mounted at the waist at baseline and at 6 months

Time frame: 6 months

Effect of intervention on Glucose levels

Glucose levels will be monitored by Continuous Glucose Monitoring at baseline and at 6 months

Time frame: 6 months

Effect of intervention on fasting insulin

Fasting insulin levels will be measured at baseline and at 6 months

Time frame: 6 months

Effect of intervention on ketone production

Fasting beta-hydroxybutyrate levels will be measured at baseline and 6 months

Time frame: 6 months

Effect of interventions on hemoglobin A1c

Hemoglobin A1c will be measured at baseline and 6 months

Time frame: 6 months

Effect of intervention on plasma leptin

Leptin levels will be measured at baseline and 6 months

Time frame: 6 months

Effect of intervention on inflammatory cytokines

Inflammatory cytokines will be measured at baseline and 6 months

Time frame: 6 months

Effect of intervention on fecal microbiome

7S sequencing will be performed on fecal samples at baseline and 6 months

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts