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

Tri-Service General Hospital

Status: Enrolling

Conditions: Lung Cancer (Diagnosis)

Treatments: Dietary Supplement: Antrodia cinnamomea supplement; Dietary Supplement: Turmeric-Probiotic Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07241182

A202505011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Antrodia cinnamomea plus turmeric and probiotics

Experimental group

Description:

Participants will receive capsules containing Antrodia cinnamomea extract, turmeric, and probiotics taken orally once daily for 3 months during platinum-based chemotherapy treatment.

Treatment:

Dietary Supplement: Antrodia cinnamomea supplement

Turmeric and probiotics only

Active Comparator group

Description:

Participants will receive capsules containing turmeric and probiotics (without Antrodia cinnamomea) taken orally once daily for 3 months during platinum-based chemotherapy treatment.

Treatment:

Dietary Supplement: Turmeric-Probiotic Group