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

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04319874
• Other study ID #: YANWQ003
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 15, 2020
• Est. completion date: September 15, 2025

Study information

• Verified date: March 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%. This study aims to improve the prognosis of patients and change the outcome of patients with osteosarcoma.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 15, 2025
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• Ganoderma lucidum
Participants take ganoderma lucidum spore powder once a day, 1000mg
• Chemotherapy
Subjects are treated with conventional chemotherapy
• Placebos
Subjects are treated with conventional chemotherapy and Placebos once a day, 1000mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of 5-year survival rate of Ganoderma osteosarcoma patients	Karnofsky (Karlfeld, KPS, percentile) functional status scoring criteria	up to 60 months