NCT07241182

Brief 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 months (24 weeks). Primary outcomes include nausea/vomiting scores, sleep quality, quality of life, and cancer symptoms.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Nov 2025Sep 2027

First Submitted

Initial submission to the registry

September 4, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

November 24, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

September 4, 2025

Last Update Submit

January 5, 2026

Conditions

Lung Cancer (Diagnosis)

Keywords

Chemotherapy side effectsLung cancerAntrodia cinnamomea

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Baseline, Week 12, and Week 24

Secondary Outcomes (1)

  • Skeletal muscle mass

    Baseline, Week 3, Week 12, Week 18, and Week 24

Study Arms (2)

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.

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.

Dietary Supplement: Turmeric-Probiotic Group

Interventions

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.

Antrodia cinnamomea plus turmeric and probiotics
Turmeric-Probiotic GroupDIETARY_SUPPLEMENT

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

Turmeric and probiotics only

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically and radio-graphically diagnosed lung cancer
  • Age greater than 18 years
  • Received platinum-based chemotherapy
  • Life expectancy of six months or longer

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsDisease

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Chen-Liang Tsai

CONTACT

886-2-8792-3311doc10376@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

September 4, 2025

First Posted

November 21, 2025

Study Start

November 24, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)