NCT04319874

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Not accepted

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%. 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.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	Ganoderma lucidum	Participants take ganoderma lucidum spore powder once a day, 1000mg
DRUG	Chemotherapy	Subjects are treated with conventional chemotherapy
DRUG	Placebos	Subjects are treated with conventional chemotherapy and Placebos once a day, 1000mg

Timeline

• Start date: 2020-09-15
• Primary completion: 2022-09-15
• Completion: 2025-09-15
• First posted: 2020-03-24
• Last updated: 2020-03-30