Gastrointestinal NeoplasmsPhase 3NCT02785523
Clinical Trial on Ganoderma Spore Lipids Combined With Chemo in Patients With G.I. Cancers
A Phase 3 study testing Ganoderma Spore Lipids and Chemotherapy in people with Gastrointestinal Neoplasms, run by Xiaonan Cui at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Neoplasms
- What is being tested?
- Ganoderma Spore Lipids and Chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2016to May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000
Xiaonan Cui, MD,PhD, +8618098876725, cxn23@sina.com
About this study
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
- Being tested
- Ganoderma Spore Lipids, Placebo, Chemotherapy
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganoderma Spore LipidsDrug
Also called G. SPORE LIPIDS
PlaceboDrug
ChemotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events: neutropenia, leukopenia, thrombocytopenia, anemia, nausea, vomit, fatigue, loss of appetite.
Measured: 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.
Measured: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Secondary outcomes (4)
Th1/Th2, Th17/Treg in blood.
Measured: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Interleukin(IL)-1b, interleukin(IL)-6, tumor necrosis factor(TNF)-α in blood.
Measured: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Estradiol (female), progesterone (female), testosterone (male) in blood.
Measured: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Vanillylmandelic acid (VMA) in urine.
Measured: Cycle 2, cycle 4, cycle 6(each cycle is 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaonan Cui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaonan Cui, The First Affiliated Hospital of Dalian Medical University
- Investigators
- Xiaonan Cui, MD, PhD, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785523
- Sponsor's protocol ID
- G20090400
- Status last verified
- May 2016
- First submitted
- 25 Mar 2016
- Last updated
- 30 May 2016
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on Ganoderma Spore Lipids Combined With Chemo in Patients With G.I. Cancers
- ClinicalTrials.gov ID
- NCT02785523
- Acronym / sponsor ID
- G20090400
- Conditions
- Gastrointestinal Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xiaonan CuiUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- First posted
- 30 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G. SPORE LIPIDS | Experimental | Drug: Ganoderma Spore Lipids, Drug: ChemotherapyForm: Capsule Dosage and frequency: This group receives ganoderma spore lipids capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: ChemotherapyForm: Capsule Dosage and frequency: This group receives placebo capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ganoderma Spore LipidsAlso: G. SPORE LIPIDS | Drug | G. SPORE LIPIDS |
| Placebo | Drug | Placebo |
| Chemotherapy | Drug | G. SPORE LIPIDS, Placebo |
Primary outcome
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).
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).
4 secondary outcomes
Th1/Th2, Th17/Treg in blood.
Time frame: 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).
Estradiol (female), progesterone (female), testosterone (male) in blood.
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaonan Cui, MD, PhD principal investigator
The First Affiliated Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ganoderma Spore Lipids and Chemotherapy in people with Gastrointestinal Neoplasms, run by Xiaonan Cui at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaonan Cui, MD, PhD (+8618098876725, cxn23@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.