Antrodia Cinnamomea Extract Effects on Lung Cancer Patients' Quality of Life During Chemotherapy

NCT ID: NCT07241182

Last Updated: 2026-01-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2027-09-30

Brief Summary

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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

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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

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Lung Cancer (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Group Type EXPERIMENTAL

Antrodia cinnamomea supplement

Intervention Type DIETARY_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.

Group Type ACTIVE_COMPARATOR

Turmeric-Probiotic Group

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Turmeric-Probiotic Group

Capsules containing turmeric and probiotics (without Antrodia cinnamomea), same dosing schedule and appearance as experimental group.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Balay Biotechnology Corporation

UNKNOWN

Sponsor Role collaborator

Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen-Liang Tsai

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tri-Service General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chen-Liang Tsai

Role: CONTACT

886-2-8792-3311 ext. 13899

Facility Contacts

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Chen-Liang Tsai

Role: primary

886-2- 8792-3311 ext. 13899

Other Identifiers

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A202505011

Identifier Type: -

Identifier Source: org_study_id

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