Lung Cancer (Diagnosis)NCT07241182
Antrodia Cinnamomea Extract Effects on Lung Cancer Patients' Quality of Life During Chemotherapy
A study testing Antrodia cinnamomea supplement and Turmeric-Probiotic Group in people with Lung Cancer (Diagnosis), run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Cancer (Diagnosis)
- What is being tested?
- Antrodia cinnamomea supplement and Turmeric-Probiotic Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Nov 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically and radio-graphically diagnosed lung cancer
- Age greater than 18 years
- Received platinum-based chemotherapy
- Life expectancy of six months or longer
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, 114
Chen-Liang Tsai, 886-2- 8792-3311 ext. 13899, doc10376@gmial.com
About this study
Official title: 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 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.
Read the detailed description
This study will test whether a nutritional supplement, Antrodia cinnamomea can help improve quality of life in lung cancer patients receiving platinum-based chemotherapy.
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
- Lung Cancer (Diagnosis)
- Being tested
- Antrodia cinnamomea supplement, Turmeric-Probiotic Group
- Keywords
- Chemotherapy side effects, Lung cancer, Antrodia cinnamomea
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antrodia cinnamomea supplementDietary 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 GroupDietary supplement
Capsules containing turmeric and probiotics (without Antrodia cinnamomea), same dosing schedule and appearance as experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Antrodia cinnamomea plus turmeric and probiotics | Experimental | Participants will receive capsules containing Antrodia cinnamomea extract, turmeric, and probiotics taken orally once daily for 3 months during platinum-based chemotherapy treatment. Receives: Dietary Supplement: Antrodia cinnamomea supplement |
| Turmeric and probiotics only | Active comparator | Participants will receive capsules containing turmeric and probiotics (without Antrodia cinnamomea) taken orally once daily for 3 months during platinum-based chemotherapy treatment. Receives: Dietary Supplement: Turmeric-Probiotic Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 3, Week 12, Week 18, and Week 24
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.
Measured: Baseline, Week 12, and Week 24
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.
Measured: Baseline, Week 12, and Week 24
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.
Measured: Baseline, Week 12, and Week 24
Secondary outcomes (1)
Skeletal muscle mass
Skeletal muscle mass as measured by bioelectrical impedance analysis (BIA), reported in kilograms.
Measured: Baseline, Week 3, Week 12, Week 18, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start24 Nov 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Collaborators
- Balay Biotechnology Corporation
- Responsible party
- Principal investigator, Chen-Liang Tsai, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241182
- Sponsor's protocol ID
- A202505011
- Status last verified
- Jan 2026
- First submitted
- 4 Sep 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07241182
- Acronym / sponsor ID
- A202505011
- Conditions
- Lung Cancer (Diagnosis)
- Keywords
- Chemotherapy side effects, Lung cancer, Antrodia cinnamomea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Collaborators
- Balay Biotechnology Corporation
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will test whether a nutritional supplement, Antrodia cinnamomea can help improve quality of life in lung cancer patients receiving platinum-based chemotherapy.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antrodia cinnamomea plus turmeric and probiotics | Experimental | Dietary Supplement: Antrodia cinnamomea supplementParticipants will receive capsules containing Antrodia cinnamomea extract, turmeric, and probiotics taken orally once daily for 3 months during platinum-based chemotherapy treatment. |
| Turmeric and probiotics only | Active comparator | Dietary Supplement: Turmeric-Probiotic GroupParticipants will receive capsules containing turmeric and probiotics (without Antrodia cinnamomea) taken orally once daily for 3 months during platinum-based chemotherapy treatment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically and radio-graphically diagnosed lung cancer
- Age greater than 18 years
- Received platinum-based chemotherapy
- Life expectancy of six months or longer
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antrodia cinnamomea 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. | Dietary supplement | Antrodia cinnamomea plus turmeric and probiotics |
| Turmeric-Probiotic GroupCapsules containing turmeric and probiotics (without Antrodia cinnamomea), same dosing schedule and appearance as experimental group. | Dietary supplement | Turmeric and probiotics only |
Primary outcome
Nausea and vomiting
Time frame: Baseline, Week 3, Week 12, Week 18, and Week 24
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
Time frame: Baseline, Week 12, and Week 24
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
Time frame: Baseline, Week 12, and Week 24
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
Time frame: Baseline, Week 12, and Week 24
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.
1 secondary outcome
Skeletal muscle mass
Time frame: Baseline, Week 3, Week 12, Week 18, and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antrodia cinnamomea supplement and Turmeric-Probiotic Group in people with Lung Cancer (Diagnosis), run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen-Liang Tsai (886-2-8792-3311 ext. 13899, doc10376@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea and vomiting (time frame: Baseline, Week 3, Week 12, Week 18, and Week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.