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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04319874
Other study ID # YANWQ003
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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