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

NCT02785523 | Unknown Phase 3

• 1 other identifier: G20090400
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Neoplasms

Outcome Measures

Primary Outcomes (2)

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

  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.

  Cycle 2, cycle 4, cycle 6(each cycle is 21 days).

Secondary Outcomes (4)

• Th1/Th2, Th17/Treg in blood.

  Cycle 2, cycle 4, cycle 6(each cycle is 21 days).

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

  Cycle 2, cycle 4, cycle 6(each cycle is 21 days).

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

  Cycle 2, cycle 4, cycle 6(each cycle is 21 days).

• Vanillylmandelic acid (VMA) in urine.

  Cycle 2, cycle 4, cycle 6(each cycle is 21 days).

Study Arms (2)

G. SPORE LIPIDS

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Ganoderma Spore Lipids DRUG

Also known as: G. SPORE LIPIDS

G. SPORE LIPIDS

Placebo DRUG

Placebo

Chemotherapy DRUG

G. SPORE LIPIDS; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaonan Cui: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xiaonan Cui, MD, PhD

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaonan Cui, MD, PhD

CONTACT

+8618098876725; cxn23@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: May 30, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2017
• Last Updated: May 30, 2016

Record last verified: 2016-05

Locations

CN (1)