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

NCT ID: NCT04319874

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2025-09-15

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.

Conditions

Osteosarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

sham group

Treated with conventional chemotherapy drugs

Group Type: SHAM_COMPARATOR

Chemotherapy

Intervention Type: DRUG

Subjects are treated with conventional chemotherapy

NC group

Treated with conventional chemotherapy drugs and Placebo

Group Type: PLACEBO_COMPARATOR

Chemotherapy

Intervention Type: DRUG

Subjects are treated with conventional chemotherapy

Placebos

Intervention Type: DRUG

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

experimental group

Treated with conventional chemotherapy drugs and Ganoderma lucidum

Group Type: EXPERIMENTAL

Ganoderma lucidum

Intervention Type: DRUG

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

Chemotherapy

Intervention Type: DRUG

Subjects are treated with conventional chemotherapy

Interventions

Ganoderma lucidum

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

Intervention Type: DRUG

Chemotherapy

Subjects are treated with conventional chemotherapy

Intervention Type: DRUG

Placebos

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

Intervention Type: DRUG

Other Intervention Names

lingzhi trearment; Chemotherapy treatment; PLacebos treatment

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

YANWQ003

Identifier Type: -

Identifier Source: org_study_id