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Clinical Trial on Ganoderma Spore Lipids Combined With Chemo in Patients With G.I. Cancers

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Xiaonan Cui

Status and phase

Unknown
Phase 3

Conditions

Gastrointestinal Neoplasms

Treatments

Drug: Placebo
Drug: Ganoderma Spore Lipids
Drug: Chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02785523
G20090400

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

G. SPORE LIPIDS
Experimental group
Description:
Form: Capsule Dosage and frequency: This group receives ganoderma spore lipids capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles.
Treatment:
Drug: Chemotherapy
Drug: Ganoderma Spore Lipids
Placebo
Placebo Comparator group
Description:
Form: Capsule Dosage and frequency: This group receives placebo capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles.
Treatment:
Drug: Chemotherapy
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Xiaonan Cui, MD, PhD

Data sourced from clinicaltrials.gov

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