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

NCT04319874 | Unknown Phase 2

• 1 other identifier: YANWQ003
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteosarcoma

Keywords

Ganoderma lucidum; osteosarcoma

Outcome Measures

Primary Outcomes (1)

• Effect of 5-year survival rate of Ganoderma osteosarcoma patients

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

  up to 60 months

Study Arms (3)

sham group

SHAM COMPARATOR

Treated with conventional chemotherapy drugs

Drug: Chemotherapy

NC group

PLACEBO COMPARATOR

Treated with conventional chemotherapy drugs and Placebo

Drug: Chemotherapy; Drug: Placebos

experimental group

EXPERIMENTAL

Treated with conventional chemotherapy drugs and Ganoderma lucidum

Drug: Ganoderma lucidum; Drug: Chemotherapy

Interventions

Ganoderma lucidum DRUG

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

Also known as: lingzhi trearment

experimental group

Chemotherapy DRUG

Subjects are treated with conventional chemotherapy

Also known as: Chemotherapy treatment

NC group; experimental group; sham group

Placebos DRUG

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

Also known as: PLacebos treatment

NC group

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Signed informed consent form
• Clinical diagnosis of osteosarcoma
• Must be able to swallow tablets
• after surgical resection

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Osteosarcoma

Interventions

Drug Therapy; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Therapeutics; Combined Modality Therapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 24, 2020
• Study Start: September 15, 2020
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2025
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share