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

Phase 2UnknownNCT04319874

Second Affiliated Hospital, Zhejiang University, School of Medicine80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Osteosarcoma

Interventions

Ganoderma lucidumDRUG

Participants take ganoderma lucidum spore powder once a day, 1000mg

ChemotherapyDRUG

Subjects are treated with conventional chemotherapy

PlacebosDRUG

Subjects are treated with conventional chemotherapy and Placebos once a day, 1000mg

Eligibility

Sex: ALLMin age: 10 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Effect of 5-year survival rate of Ganoderma osteosarcoma patients

Karnofsky (Karlfeld, KPS, percentile) functional status scoring criteria

Time frame: up to 60 months

Data from ClinicalTrials.gov

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