Clinical Trial on Ganoderma Spore Lipids Combined With Chemo in Patients With G.I. Cancers
试验速览
- 阶段
- 3 期
- 发起方
- Xiaonan Cui
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adverse Events: neutropenia, leukopenia, thrombocytopenia, anemia, nausea, vomit, fatigue, loss of appetite.
研究概览
简要总结
A phase III double-blind randomized clinical trial on the effects of ganoderma spore lipids to the immunological response in patients with G.I. Cancers. The trial is randomized, double-blind. Cancer patients are diagnosed based on pathology or cell biology. Patients are randomized into 2 groups: both groups receive chemotherapy. Either group receives ganoderma spore lipids or placebo capsules 600mg three times a day (TID) in addition to the chemotherapy. Clinical evaluation includes chemotherapy drug toxicities, life quality improvement. Blood biochemistry tests mainly include malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, interleukin (IL)-1b, interleukin (IL)-6, cell flow cytometry on Th1, Th2, Th17, Treg cytokines, as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male), etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80, male and female.
- •Diagnosis: imaging, cell and pathology report.
- •Eastern Cooperative Oncology Group (ECOG) O-2, life expectancy more than 3 months.
- •Chemotherapy is not contraindicated.
- •No apparent surgical trauma during the previous 2 weeks.
- •Past treatment:
- •Biological treatment: at least 4 weeks after previous treatment with immunotherapy or other biological; chemotherapy, at least 6 months after last treatment with chemotherapy and or target therapy.
- •Surgery: had not received transplantation surgery, at least 2 weeks after last major surgery.
排除标准
- •A purulent and chronic infection of wound healing delayed.
- •Diseases of the blood system.
- •Abnormal blood coagulation function.
- •Severe brain disease or primary brain tumors without control, and mentally ill person.
- •Patients with brain metastases.
- •Pregnant or lactating women.
- •Patients (male/female) with fertility, But the patients themselves or their spouses do not take effective contraception.
- •Allergic constitution.
- •In addition, patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.
研究组 & 干预措施
G. SPORE LIPIDS
Form: Capsule Dosage and frequency: This group receives ganoderma spore lipids capsules 600mg TID in addition to the chemotherapy.
Duration: 6 chemotherapy cycles.
干预措施: Ganoderma Spore Lipids (Drug)
G. SPORE LIPIDS
Form: Capsule Dosage and frequency: This group receives ganoderma spore lipids capsules 600mg TID in addition to the chemotherapy.
Duration: 6 chemotherapy cycles.
干预措施: Chemotherapy (Drug)
Placebo
Form: Capsule Dosage and frequency: This group receives placebo capsules 600mg TID in addition to the chemotherapy.
Duration: 6 chemotherapy cycles.
干预措施: Placebo (Drug)
Placebo
Form: Capsule Dosage and frequency: This group receives placebo capsules 600mg TID in addition to the chemotherapy.
Duration: 6 chemotherapy cycles.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Adverse Events: neutropenia, leukopenia, thrombocytopenia, anemia, nausea, vomit, fatigue, loss of appetite.
时间窗: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Assessing the quality of life(QOL) in 5 grades and recording: appetite, mental state, sleep, fatigue, pain, attitude towards treatment, daily life ability, treatment of severity of side effects.
时间窗: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
次要结局
- Th1/Th2, Th17/Treg in blood.(Cycle 2, cycle 4, cycle 6(each cycle is 21 days).)
- Interleukin(IL)-1b, interleukin(IL)-6, tumor necrosis factor(TNF)-α in blood.(Cycle 2, cycle 4, cycle 6(each cycle is 21 days).)
- Estradiol (female), progesterone (female), testosterone (male) in blood.(Cycle 2, cycle 4, cycle 6(each cycle is 21 days).)
- Vanillylmandelic acid (VMA) in urine.(Cycle 2, cycle 4, cycle 6(each cycle is 21 days).)
研究者
Xiaonan Cui
Professor, Chief Physician
The First Affiliated Hospital of Dalian Medical University