Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma

Conditions
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Osteosarcoma

Intervention / Treatment
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* Drug: Ganoderma lucidum
* Drug: Chemotherapy
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Signed informed consent form Clinical diagnosis of osteosarcoma Must be able to swallow tablets after surgical resection Exclusion Criteria: - 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 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: sham group<br>Treated with conventional chemotherapy drugs | Drug: Chemotherapy<br>* Subjects are treated with conventional chemotherapy<br>* Other names: Chemotherapy treatment;|
| Placebo Comparator: NC group<br>Treated with conventional chemotherapy drugs and Placebo | Drug: Chemotherapy<br>* Subjects are treated with conventional chemotherapy<br>* Other names: Chemotherapy treatment;Drug: Placebos<br>* Subjects are treated with conventional chemotherapy and Placebos once a day, 1000mg<br>* Other names: PLacebos treatment;|
| Experimental: experimental group<br>Treated with conventional chemotherapy drugs and Ganoderma lucidum | Drug: Ganoderma lucidum<br>* Participants take ganoderma lucidum spore powder once a day, 1000mg<br>* Other names: lingzhi trearment;Drug: Chemotherapy<br>* Subjects are treated with conventional chemotherapy<br>* Other names: Chemotherapy treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of 5-year survival rate of Ganoderma osteosarcoma patients | Karnofsky (Karlfeld, KPS, percentile) functional status scoring criteria | up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ganoderma lucidum, osteosarcoma