Antrodia cinnamomea supplement to improve quality of life during chemotherapy for lung cancer
The Effects of Antrodia Cinnamomea Fruiting Body Extract on Quality of Life and Chemotherapy Side Effects in Patients With Lung Cancer Undergoing Platinum-Based Chemotherapy
This trial will test whether taking a daily Antrodia cinnamomea-containing capsule helps people with lung cancer on platinum chemotherapy feel better by reducing nausea, improving sleep, and easing cancer-related symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Tri-Service General Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07241182 on ClinicalTrials.gov |
What this trial studies
Adults with pathologically or radiographically confirmed lung cancer who are receiving platinum-based chemotherapy at Tri-Service General Hospital will be randomly assigned in a double-blind manner to receive either a capsule containing Antrodia cinnamomea plus turmeric and probiotics or a capsule with turmeric and probiotics only. Participants will take the assigned capsules daily for three months with continued follow-up for a total of six months (24 weeks). Researchers will use validated questionnaires to measure nausea and vomiting, sleep quality, overall quality of life, and other cancer-related symptoms and will compare outcomes between the two groups. The trial is conducted at Tri-Service General Hospital in Taipei and is sponsored by that hospital with collaboration from Balay Biotechnology Corporation.
Who should consider this trial
Good fit: Adults (age >18) with pathologically or radiographically confirmed lung cancer who are receiving platinum-based chemotherapy, have a life expectancy of at least six months, can take daily oral supplements, and meet laboratory and clinical safety requirements are ideal candidates.
Not a fit: Patients already taking Antrodia camphorata supplements, those with abnormal recent liver or kidney tests, active acute infections, major cardiac disease, severe neuropathy, known allergies to study ingredients, or those unable to comply with daily supplementation may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the supplement could reduce chemotherapy-related nausea, improve sleep, and meaningfully improve overall quality of life for patients receiving platinum-based chemotherapy for lung cancer.
How similar studies have performed: There are limited clinical data specifically on Antrodia cinnamomea for chemotherapy side effects; some preclinical and small human studies suggest potential benefits but robust randomized evidence is lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically and radio-graphically diagnosed lung cancer * Age greater than 18 years * Received platinum-based chemotherapy * Life expectancy of six months or longer Exclusion Criteria: * 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. * Major cardiac disease or arrhythmia severe enough that the attending physician considers the patient unsuitable for trial participation. * Major neuropathy. * Patients with currently active acute infections. * Patients with known allergies/allergic reactions to the investigational product or any components in their formulations. * Patients currently taking supplements containing Antrodia camphorata extract.
Where this trial is running
Taipei
- Tri-Service General Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chen-Liang Tsai
- Email: doc10376@gmail.com
- Phone: 886-2-8792-3311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.