Clinical trial NCT02785523: Clinical Trial on Ganoderma Spore Lipids Combined With Chemo in Patients With G.I. Cancers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastrointestinal Neoplasms
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events: neutropenia, leukopenia, thrombocytopenia, anemia, nausea, vomit, fatigue, loss of appetite.
timeFrame: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
measure: 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.
timeFrame: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Secondary outcomes:
measure: Th1/Th2, Th17/Treg in blood.
timeFrame: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
measure: Interleukin(IL)-1b, interleukin(IL)-6, tumor necrosis factor(TNF)-α in blood.
timeFrame: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
measure: Estradiol (female), progesterone (female), testosterone (male) in blood.
timeFrame: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
measure: Vanillylmandelic acid (VMA) in urine.
timeFrame: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Other outcomes:
Locations:
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Xiaonan Cui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: