Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07241182

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antrodia cinnamomea supplement

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-Probiotic Group

Dietary Supplement

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chen-Liang Tsai

CONTACT

[email protected]

886-2-8792-3311 ext. 13899

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Collaborators

  • Balay Biotechnology Corporation

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 21, 2025
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.