This randomized trial will test whether Antrodia cinnamomea supplement improves quality of life in lung cancer patients receiving platinum-based chemotherapy.
Participants at Tri-Service General Hospital will be randomized to receive either Antrodia cinnamomea capsules or placebo for 3 months, with follow-up to 6 months (24 weeks). Primary outcomes include nausea/vomiting scores, sleep quality, quality of life, and cancer symptoms.
Pathologically and radio-graphically diagnosed lung cancer
Age greater than 18 years
Received platinum-based chemotherapy
Life expectancy of six months or longer
Inability to comply with timely supplementation administration.
Within 14 days prior to trial entry, laboratory data showing abnormal liver function, abnormal kidney function
Within 30 days prior to trial entry, unexplained fever ≥38.5°C for 7 consecutive days or chronic diarrhea for 15 consecutive days.
Currently receiving hormone therapy.
Parallel
Antrodia cinnamomea supplement
Dietary supplementIntervention Description: Oral capsules containing Antrodia cinnamomea fruiting body extract combined with turmeric and probiotics, administered once daily for 3 months during platinum-based chemotherapy treatment. Each capsule contains standardized amounts of Antrodia cinnamomea extract, curcumin (from turmeric), and probiotic strains.
Turmeric-Probiotic Group
Dietary supplementCapsules containing turmeric and probiotics (without Antrodia cinnamomea), same dosing schedule and appearance as experimental group.
Nausea and vomiting
The Rhodes index of nausea, vomiting and retching (RINVR) will be used. While each item is scored from 0 to 4, the total possible score on the 8-item index is 32, with higher scores indicating greater severity.
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) will be used. Each component score of the PSQI ranges from 0 to 3, with the total possible score on the 7-component index being 21. The 0-3 scale assesses sleep dysfunction and disturbance, with higher scores indicating poorer sleep quality.
Symptom assessment
The MD Anderson Symptom Inventory (MDASI) will be used. MDASI contains 19 items scored from 0 to 10, assessing symptom severity (13 items) and interference with daily activities (6 items). Higher scores indicate greater symptom burden.
Overall quality of life
The EORTC QLQ-LC13 will be used. Each item on the 13-item EORTC QLQ-LC13 is scored from 1 to 4, assessing lung cancer-specific symptoms. Higher scores indicate greater symptom severity.
Skeletal muscle mass
Skeletal muscle mass as measured by bioelectrical impedance analysis (BIA), reported in kilograms.
Click on the lead sponsor to view all of their trials.
Tri-Service General Hospital
Lead sponsor
Balay Biotechnology Corporation
Collaborator
