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

Primary Purpose

Gastrointestinal Neoplasms

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Ganoderma Spore Lipids

Placebo

Chemotherapy

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

The First Affiliated Hospital of Dalian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

G. SPORE LIPIDS

Placebo

Arm Description

Form: Capsule Dosage and frequency: This group receives ganoderma spore lipids capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles.

Form: Capsule Dosage and frequency: This group receives placebo capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles.

Outcomes

Primary Outcome Measures

Adverse Events: neutropenia, leukopenia, thrombocytopenia, anemia, nausea, vomit, fatigue, loss of appetite.

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.

Secondary Outcome Measures

Th1/Th2, Th17/Treg in blood.

Interleukin(IL)-1b, interleukin(IL)-6, tumor necrosis factor(TNF)-α in blood.

Estradiol (female), progesterone (female), testosterone (male) in blood.

Vanillylmandelic acid (VMA) in urine.

Full Information

NCT ID

NCT02785523

First Posted

March 25, 2016

Last Updated

May 24, 2016

Sponsor

Xiaonan Cui

1. Study Identification

Unique Protocol Identification Number

NCT02785523

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

May 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiaonan Cui

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

G. SPORE LIPIDS

Arm Type

Experimental

Arm Description

Form: Capsule Dosage and frequency: This group receives ganoderma spore lipids capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Form: Capsule Dosage and frequency: This group receives placebo capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles.

Intervention Type

Drug

Intervention Name(s)

Ganoderma Spore Lipids

Other Intervention Name(s)

G. SPORE LIPIDS

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Primary Outcome Measure Information:

Title

Adverse Events: neutropenia, leukopenia, thrombocytopenia, anemia, nausea, vomit, fatigue, loss of appetite.

Time Frame