Clinical trial NCT04319874: Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma
Official title: Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Osteosarcoma
Keywords: Ganoderma lucidum
osteosarcoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of 5-year survival rate of Ganoderma osteosarcoma patients
timeFrame: up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: