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

January 5, 2026 updated by: Chen-Liang Tsai, Tri-Service General Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: 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.
Active Comparator: 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.
Dietary supplement: Turmeric-Probiotic Group
Capsules containing turmeric and probiotics (without Antrodia cinnamomea), same dosing schedule and appearance as experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 3, Week 12, Week 18, and Week 24
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.
Baseline, Week 12, and Week 24
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.
Baseline, Week 12, and Week 24
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.
Baseline, Week 12, and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal muscle mass
Time Frame: Baseline, Week 3, Week 12, Week 18, and Week 24
Skeletal muscle mass as measured by bioelectrical impedance analysis (BIA), reported in kilograms.
Baseline, Week 3, Week 12, Week 18, and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Collaborators

Balay Biotechnology Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

September 4, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Estimated)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A202505011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer (Diagnosis)

Clinical Trials on Antrodia cinnamomea supplement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe