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

May 24, 2016 updated by: Xiaonan Cui
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaonan Cui, MD, PhD
  • Phone Number: +8618098876725
  • Email: cxn23@sina.com

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Recruiting
        • The First Affiliated Hospital of Dalian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: G. SPORE LIPIDS

Form: Capsule Dosage and frequency: This group receives ganoderma spore lipids capsules 600mg TID in addition to the chemotherapy.

Duration: 6 chemotherapy cycles.
Drug: Chemotherapy
Drug: Ganoderma Spore Lipids
Other Names:
  • G. SPORE LIPIDS
Placebo Comparator: Placebo

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
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).
Cycle 2, cycle 4, cycle 6(each cycle is 21 days).

Secondary Outcome Measures

Outcome Measure
Time Frame
Th1/Th2, Th17/Treg in blood.
Time Frame: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
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).
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).
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).
Cycle 2, cycle 4, cycle 6(each cycle is 21 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaonan Cui

Investigators

  • Principal Investigator: Xiaonan Cui, MD, PhD, The First Affiliated Hospital of Dalian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

March 25, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 30, 2016

Study Record Updates

Last Update Posted (Estimate)

May 30, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G20090400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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