A Phase 3 interventional study of Ganoderma Spore Lipids and Placebo in Gastrointestinal Neoplasms, sponsored by Xiaonan Cui. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-05-30.
Sponsored by Xiaonan Cui · Phase 3, Interventional, and Treatment
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.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Xiaonan Cui is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Past treatment:
Exclusion Criteria:
Form: Capsule Dosage and frequency: This group receives ganoderma spore lipids capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles.
Drug: Ganoderma Spore Lipids · Drug: Chemotherapy
Form: Capsule Dosage and frequency: This group receives placebo capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles.
Drug: Placebo · Drug: Chemotherapy
Also known as: G. SPORE LIPIDS
Adverse Events: neutropenia, leukopenia, thrombocytopenia, anemia, nausea, vomit, fatigue, loss of appetite.
Time frame: 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.
Time frame: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Th1/Th2, Th17/Treg in blood.
Time frame: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Interleukin(IL)-1b, interleukin(IL)-6, tumor necrosis factor(TNF)-α in blood.
Time frame: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Estradiol (female), progesterone (female), testosterone (male) in blood.
Time frame: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Vanillylmandelic acid (VMA) in urine.
Time frame: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Plan to share: Undecided
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This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Xiaonan Cui