MedTrace Logo

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

NCT02785523 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-05-30

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Neoplasms

Interventions

DRUG

Ganoderma Spore Lipids

DRUG

Placebo

DRUG

Chemotherapy

Sponsors & Collaborators

  • Xiaonan Cui

    lead OTHER

Principal Investigators

  • Xiaonan Cui, MD, PhD · The First Affiliated Hospital of Dalian Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02785523 on ClinicalTrials.gov