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

Phase 2

Not yet recruiting

• Conditions: Osteosarcoma
• Interventions: Drug: Chemotherapy; Drug: Ganoderma lucidum; Drug: Placebos

• Registration Number: NCT04319874
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-22
• Study First Posted: 2020-03-24
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-30
• Study Start: 2020-09-15
• Primary Completion: 2022-09-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NC group	Chemotherapy	Treated with conventional chemotherapy drugs and Placebo
experimental group	Ganoderma lucidum	Treated with conventional chemotherapy drugs and Ganoderma lucidum
experimental group	Chemotherapy	Treated with conventional chemotherapy drugs and Ganoderma lucidum
sham group	Chemotherapy	Treated with conventional chemotherapy drugs
NC group	Placebos	Treated with conventional chemotherapy drugs and Placebo

Primary Outcome Measures

Name	Time	Method
Effect of 5-year survival rate of Ganoderma osteosarcoma patients	up to 60 months	Karnofsky (Karlfeld, KPS, percentile) functional status scoring criteria