Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G. SPORE LIPIDS | Experimental | Form: Capsule Dosage and frequency: This group receives ganoderma spore lipids capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles. |
|
| Placebo | Placebo Comparator | Form: Capsule Dosage and frequency: This group receives placebo capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganoderma Spore Lipids | Drug |
|
| |
| Placebo |
| Measure | Description | 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). |
| Measure | Description | 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). |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaonan Cui, MD, PhD | Contact | +8618098876725 | cxn23@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaonan Cui, MD, PhD | The First Affiliated Hospital of Dalian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Chemotherapy | Drug |
|
| 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). |
| D005767 |
| Gastrointestinal Diseases |