Gastrointestinal Neoplasms
Conditions
Brief summary
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.
Interventions
DRUGGanoderma Spore Lipids
DRUGPlacebo
DRUGChemotherapy
Sponsors
Xiaonan Cui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events: neutropenia, leukopenia, thrombocytopenia, anemia, nausea, vomit, fatigue, loss of appetite. | 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. | Cycle 2, cycle 4, cycle 6(each cycle is 21 days). |
Secondary
| Measure | Time frame |
|---|---|
| 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). |
Countries
China
Contacts
Primary ContactXiaonan Cui, MD, PhD
Outcome results
None listed