Hepatocellular Carcinoma (HCC)
Conditions
Brief summary
This prospective, randomized controlled trial investigates the efficacy of a targeted dietary intervention in patients with hepatocellular carcinoma (HCC). The study aims to compare a structured diet including probiotics and prebiotics against routine dietary care. The primary goal is to assess the impact on clinical outcomes (survival), gut microbiota composition, systemic lipid metabolism, and anti-tumor immune responses, to determine if this intervention can serve as an effective adjunctive therapy for HCC.
Detailed description
Hepatocellular carcinoma (HCC) is associated with gut microbiota dysbiosis, which contributes to a pro-inflammatory and immunosuppressive tumor microenvironment via the gut-liver axis. This study hypothesizes that modulating the gut microbiota through a targeted dietary intervention can rebalance systemic immunity and improve clinical outcomes. This single-center, prospective trial randomized 100 patients with HCC into two groups. The experimental group (n=50) received a structured dietary plan including high-fiber foods, probiotics (Bifidobacterium, Lactobacillus), and prebiotics. The control group (n=50) received routine dietary counseling. The study evaluates the intervention's effects on progression-free survival (PFS), overall survival (OS), gut microbiota diversity, serum lipid profiles, peripheral immune cell populations (CD8+ T cells, Tregs), and quality of life. The findings aim to provide robust clinical evidence for integrating microbiota-targeted dietary therapy into the standard management of HCC.
Interventions
BEHAVIORALStructured Dietary Intervention
A comprehensive dietary program consisting of dietary modification (high-fiber, lean protein), daily probiotic supplementation capsule (Bifidobacterium longum, Lactobacillus acidophilus, and Lactobacillus rhamnosus), and encouraged intake of prebiotics and unsaturated fatty acids.
BEHAVIORALRoutine Dietary Care
Standard institutional dietary counseling for patients with HCC, providing general advice on nutrition.
Sponsors
The First Hospital of Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 80 years. * Pathologically confirmed primary Hepatocellular Carcinoma (HCC). * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Adequate organ function (e.g., liver, renal, and bone marrow). * Life expectancy of at least 3 months. * Willingness to provide informed consent and adhere to study procedures.
Exclusion criteria
* Concurrent malignancies other than HCC. * Severe, uncontrolled comorbidities (e.g., congestive heart failure, renal failure). * Known history of severe intestinal diseases such as inflammatory bowel disease. * Use of antibiotics, probiotics, or other microbiota-altering agents within 4 weeks prior to enrollment. * Cognitive impairment precluding understanding of the study. * Refusal to provide consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Through study completion, an average of 12 months | Defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurred first. Disease progression was assessed according to standard oncologic criteria. |
| Overall Survival (OS) | Through study completion, an average of 12 months | Defined as the time from randomization to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Lipid Profile | Baseline, 12 months | Measured levels of serum cholesterol and triglycerides. |
| Change in Gut Microbiota Alpha-Diversity | Baseline, 12 months | Measured by the Shannon and Simpson indices from fecal samples using 16S rRNA sequencing. |
| Incidence of Treatment-Related Adverse Events | Throughout the study duration, up to 18 months | Safety and tolerability assessed by documenting adverse events throughout the study. |
| Change in Health-Related Quality of Life (QOL) | Baseline, 12 months | Assessed using the World Health Organization Quality of Life (WHOQOL-100) questionnaire. Scores for each domain range from 4 to 20, with higher scores indicating a better quality of life. |
| Change in Gut Microbiota Composition | Baseline, 12 months | Relative abundance of key bacterial genera (e.g., Bifidobacterium, Lactobacillus, Escherichia coli) assessed by 16S rRNA sequencing. |
Countries
China
Outcome results
None listed