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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка Turmeric-Probiotic Group
  Capsules containing turmeric and probiotics (without Antrodia cinnamomea), same dosing schedule and appearance as experimental group.

Первичные конечные точки

• Nausea and vomiting [Срок оценки: Baseline, Week 3, Week 12, Week 18, and Week 24]
• Sleep quality [Срок оценки: Baseline, Week 12, and Week 24]
• Symptom assessment [Срок оценки: Baseline, Week 12, and Week 24]
• Overall quality of life [Срок оценки: Baseline, Week 12, and Week 24]

Вторичные конечные точки (1)

• Skeletal muscle mass [Срок оценки: Baseline, Week 3, Week 12, Week 18, and Week 24]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

• Tri-Service General Hospital — Taipei

Идентификаторы

NCT: NCT07241182 · A202505011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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