Antrodia Cinnamomea Extract Effects on Lung Cancer Patients' Quality of Life During Chemotherapy
NCT ID: NCT07241182
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-11-24
2027-09-30
Brief Summary
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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.
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Detailed Description
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Lung cancer patients often experience side effects from chemotherapy treatment, including nausea, vomiting, sleep problems, and other symptoms that affect their daily life. Antrodia cinnamomea is a medicinal mushroom supplement that may help reduce these side effects.
The study will include lung cancer patients who are receiving platinum-based chemotherapy at Tri-Service General Hospital. Participants will be randomly assigned to one of two groups: Participants will be randomly assigned to one of two groups: half will receive capsules containing turmeric, probiotics, and Antrodia cinnamomea, and half will receive capsules containing only turmeric and probiotics. Neither participants nor doctors will know which treatment each person is receiving.
All participants will take their assigned capsules daily for 3 months. Researchers will then continue to follow participants for an additional 3 months (up to 6 months total or 24 weeks) to monitor the lasting effects of the supplement. During this time, researchers will use questionnaires to measure nausea and vomiting, sleep quality, and cancer-related symptoms. The study will compare these measurements between the two groups to see if Antrodia cinnamomea supplement helps improve quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Antrodia cinnamomea plus turmeric and probiotics
Participants will receive capsules containing Antrodia cinnamomea extract, turmeric, and probiotics taken orally once daily for 3 months during platinum-based chemotherapy treatment.
Antrodia cinnamomea supplement
Intervention 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 and probiotics only
Participants will receive capsules containing turmeric and probiotics (without Antrodia cinnamomea) taken orally once daily for 3 months during platinum-based chemotherapy treatment.
Turmeric-Probiotic Group
Capsules containing turmeric and probiotics (without Antrodia cinnamomea), same dosing schedule and appearance as experimental group.
Interventions
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Antrodia cinnamomea supplement
Intervention 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
Capsules containing turmeric and probiotics (without Antrodia cinnamomea), same dosing schedule and appearance as experimental group.
Eligibility Criteria
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Inclusion Criteria
* Age greater than 18 years
* Received platinum-based chemotherapy
* Life expectancy of six months or longer
Exclusion Criteria
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Balay Biotechnology Corporation
UNKNOWN
Tri-Service General Hospital
OTHER
Responsible Party
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Chen-Liang Tsai
Attending Physician
Locations
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Tri-Service General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A202505011
Identifier Type: -
Identifier Source: org_study_id
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