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

Zhejiang University

Status and phase: Not yet enrolling; Phase 2

Conditions: Osteosarcoma

Treatments: Drug: Chemotherapy; Drug: Placebos; Drug: Ganoderma lucidum

Study type: Interventional

Funder types: Other

Identifiers

NCT04319874

YANWQ003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 10 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 3 patient groups, including a placebo group

sham group

Sham Comparator group

Description:

Treated with conventional chemotherapy drugs

Treatment:

Drug: Chemotherapy

NC group

Placebo Comparator group

Description:

Treated with conventional chemotherapy drugs and Placebo

Treatment:

Drug: Placebos

Drug: Chemotherapy

experimental group

Experimental group

Description:

Treated with conventional chemotherapy drugs and Ganoderma lucidum

Treatment:

Drug: Ganoderma lucidum

Drug: Chemotherapy