OsteosarcomaPhase 2NCT04319874
Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma
A Phase 2 study testing Ganoderma lucidum and Chemotherapy in people with Osteosarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Osteosarcoma is the most common primary highly malignant bone tumor in children and young people. Incidence rates are bimodal, with the first peak occurring in adolescence and the second peak in patients over 60 years of age. The 5-year survival rate of patients with osteosarcoma is less than 20%. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Ganoderma lucidum and Chemotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2020to 15 Sep 2025
- Phase
- Phase 2
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent form
- Clinical diagnosis of osteosarcoma
- Must be able to swallow tablets
- after surgical resection
Who cannot join
- Symptomatic central nervous system metastases and/or carcinomatous meningitis Known HIV or active hepatitis B/C infection
- Active infection requiring systemic treatment
- Clinically significant cardiac arrhythmias
- Class III or IV Congestive Heart Failure as defined by the New York Heart
- Association functional classification system < 6 months prior to screening
- A pregnant or nursing female, or women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
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- Any condition for which participation would not be in the best interest of the participant
- Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements
- Patients participating in another clinical investigation at the time of signature of the informed consent
About this study
Osteosarcoma is the most common primary highly malignant bone tumor in children and young people. Incidence rates are bimodal, with the first peak occurring in adolescence and the second peak in patients over 60 years of age. The 5-year survival rate of patients with osteosarcoma is less than 20%. This study aims to improve the prognosis of patients and change the outcome of patients with osteosarcoma.
Read the detailed description
This project intends to conduct a multicenter, randomized, double-blind, parallel-controlled clinical trial of ganoderma spore powder and doxorubicin combined with cisplatin chemotherapy in the treatment of osteosarcoma patients. The combination therapy of traditional chemotherapeutics has not played a good effect and has large side effects. The Ganoderma lucidum spore powder group is a natural botanical drug that has a good anti-tumor auxiliary effect in regulating the tumor immune microenvironment. The investigators' previous research showed that Ganoderma lucidum spore powder can inhibit the growth and metastasis of osteosarcoma in the body without obvious toxic and side effects, which indicates that this research scheme has strong feasibility.
- Conditions
- Osteosarcoma
- Being tested
- Ganoderma lucidum, Chemotherapy, Placebos
- Keywords
- Ganoderma lucidum, osteosarcoma
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganoderma lucidumDrug
Also called lingzhi trearment
Participants take ganoderma lucidum spore powder once a day, 1000mg
ChemotherapyDrug
Also called Chemotherapy treatment
Subjects are treated with conventional chemotherapy
PlacebosDrug
Also called PLacebos treatment
Subjects are treated with conventional chemotherapy and Placebos once a day, 1000mg
| Study group | Role | What they receive |
|---|---|---|
| sham group | Sham comparator | Treated with conventional chemotherapy drugs Receives: Drug: Chemotherapy |
| NC group | Placebo comparator | Treated with conventional chemotherapy drugs and Placebo Receives: Drug: Chemotherapy; Drug: Placebos |
| experimental group | Experimental | Treated with conventional chemotherapy drugs and Ganoderma lucidum Receives: Drug: Ganoderma lucidum; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of 5-year survival rate of Ganoderma osteosarcoma patients
Karnofsky (Karlfeld, KPS, percentile) functional status scoring criteria
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start15 Sep 2020 (estimated)
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319874
- Sponsor's protocol ID
- YANWQ003
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma
- ClinicalTrials.gov ID
- NCT04319874
- Acronym / sponsor ID
- YANWQ003
- Conditions
- Osteosarcoma
- Keywords
- Ganoderma lucidum, osteosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 24 Mar 2020 (actual)
- 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.
Osteosarcoma is the most common primary highly malignant bone tumor in children and young people. Incidence rates are bimodal, with the first peak occurring in adolescence and the second peak in patients over 60 years of age. The 5-year survival rate of patients with osteosarcoma is less than 20%. This study aims to improve the prognosis of patients and change the outcome of patients with osteosarcoma.
Detailed description
This project intends to conduct a multicenter, randomized, double-blind, parallel-controlled clinical trial of ganoderma spore powder and doxorubicin combined with cisplatin chemotherapy in the treatment of osteosarcoma patients. The combination therapy of traditional chemotherapeutics has not played a good effect and has large side effects. The Ganoderma lucidum spore powder group is a natural botanical drug that has a good anti-tumor auxiliary effect in regulating the tumor immune microenvironment. The investigators' previous research showed that Ganoderma lucidum spore powder can inhibit the growth and metastasis of osteosarcoma in the body without obvious toxic and side effects, which indicates that this research scheme has strong feasibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sham group | Sham comparator | Drug: ChemotherapyTreated with conventional chemotherapy drugs |
| NC group | Placebo comparator | Drug: Chemotherapy, Drug: PlacebosTreated with conventional chemotherapy drugs and Placebo |
| experimental group | Experimental | Drug: Ganoderma lucidum, Drug: ChemotherapyTreated with conventional chemotherapy drugs and Ganoderma lucidum |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Signed informed consent form
- Clinical diagnosis of osteosarcoma
- Must be able to swallow tablets
- after surgical resection
Key exclusion criteria (9 listed)
- Symptomatic central nervous system metastases and/or carcinomatous meningitis Known HIV or active hepatitis B/C infection
- Active infection requiring systemic treatment
- Clinically significant cardiac arrhythmias
- Class III or IV Congestive Heart Failure as defined by the New York Heart
- Association functional classification system < 6 months prior to screening
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 lucidumAlso: lingzhi trearmentParticipants take ganoderma lucidum spore powder once a day, 1000mg | Drug | experimental group |
| ChemotherapyAlso: Chemotherapy treatmentSubjects are treated with conventional chemotherapy | Drug | NC group, experimental group, sham group |
| PlacebosAlso: PLacebos treatmentSubjects are treated with conventional chemotherapy and Placebos once a day, 1000mg | Drug | NC group |
Primary outcome
Effect of 5-year survival rate of Ganoderma osteosarcoma patients
Time frame: up to 60 months
Karnofsky (Karlfeld, KPS, percentile) functional status scoring criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ganoderma lucidum and Chemotherapy in people with Osteosarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 4 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 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of 5-year survival rate of Ganoderma osteosarcoma patients (time frame: up to 60 months). 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 Mar 2020.