Clinical trial NCT06824974: To Test Whether Time-restricted Eating Coupled With a Healthy Diet is Beneficial in Liver Cancer Patients
Official title: Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Cancer, Adult
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Obesity and Overweight
Keywords: Time-restricted eating
healthy diet
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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?


Eligibility criteria: 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

Primary outcomes:
measure: Adherence to protocol
timeFrame: 6 months
measure: Safety from adverse events
timeFrame: 6 months
measure: Ability to recruit
timeFrame: 6 months
measure: Satisfaction and self-motivation
timeFrame: 6 months
Secondary outcomes:
measure: Effect of intervention on Quality of Life
timeFrame: 6 months
measure: Effect of interventions on fasting glucose
timeFrame: 6-months
measure: Sleep disturbance
timeFrame: 6 months
measure: Effect of intervention on body weight
timeFrame: 6 months
measure: Effect of intervention on food frequency
timeFrame: 6 months
measure: Effect of intervention on Adiposity
timeFrame: 6 months
measure: Effect of interventions on Physical activity
timeFrame: 6 months
measure: Effect of intervention on Glucose levels
timeFrame: 6 months
measure: Effect of intervention on fasting insulin
timeFrame: 6 months
measure: Effect of intervention on ketone production
timeFrame: 6 months
measure: Effect of interventions on hemoglobin A1c
timeFrame: 6 months
measure: Effect of intervention on plasma leptin
timeFrame: 6 months
measure: Effect of intervention on inflammatory cytokines
timeFrame: 6 months
measure: Effect of intervention on fecal microbiome
timeFrame: 6 months
Other outcomes:
measure: Disease progression as a Tertiary/Exploratory outcome
timeFrame: 12-months
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: Universoty of California San Diego
name: Nick Webster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Das M, Kumar D, Sauceda C, Oberg A, Ellies LG, Zeng L, Jih LJ, Newton IG, Webster NJG. Time-Restricted Feeding Attenuates Metabolic Dysfunction-Associated Steatohepatitis and Hepatocellular Carcinoma in Obese Male Mice. Cancers (Basel). 2024 Apr 16;16(8):1513. doi: 10.3390/cancers16081513.
citation: Das M, Webster NJG. Obesity, cancer risk, and time-restricted eating. Cancer Metastasis Rev. 2022 Sep;41(3):697-717. doi: 10.1007/s10555-022-10061-3. Epub 2022 Aug 19.