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

Primary Purpose

Osteosarcoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ganoderma lucidum
Chemotherapy
Placebos
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring Ganoderma lucidum, osteosarcoma

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Sham Comparator

    Placebo Comparator

    Experimental

    Arm Label

    sham group

    NC group

    experimental group

    Arm Description

    Treated with conventional chemotherapy drugs

    Treated with conventional chemotherapy drugs and Placebo

    Treated with conventional chemotherapy drugs and Ganoderma lucidum

    Outcomes

    Primary Outcome Measures

    Effect of 5-year survival rate of Ganoderma osteosarcoma patients
    Karnofsky (Karlfeld, KPS, percentile) functional status scoring criteria

    Secondary Outcome Measures

    Full Information

    First Posted
    March 16, 2020
    Last Updated
    March 27, 2020
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04319874
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2020 (Anticipated)
    Primary Completion Date
    September 15, 2022 (Anticipated)
    Study Completion Date
    September 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteosarcoma
    Keywords
    Ganoderma lucidum, osteosarcoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    sham group
    Arm Type
    Sham Comparator
    Arm Description
    Treated with conventional chemotherapy drugs
    Arm Title
    NC group
    Arm Type
    Placebo Comparator
    Arm Description
    Treated with conventional chemotherapy drugs and Placebo
    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    Treated with conventional chemotherapy drugs and Ganoderma lucidum
    Intervention Type
    Drug
    Intervention Name(s)
    Ganoderma lucidum
    Other Intervention Name(s)
    lingzhi trearment
    Intervention Description
    Participants take ganoderma lucidum spore powder once a day, 1000mg
    Intervention Type
    Drug
    Intervention Name(s)
    Chemotherapy
    Other Intervention Name(s)
    Chemotherapy treatment
    Intervention Description
    Subjects are treated with conventional chemotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Other Intervention Name(s)
    PLacebos treatment
    Intervention Description
    Subjects are treated with conventional chemotherapy and Placebos once a day, 1000mg
    Primary Outcome Measure Information:
    Title
    Effect of 5-year survival rate of Ganoderma osteosarcoma patients
    Description
    Karnofsky (Karlfeld, KPS, percentile) functional status scoring criteria
    Time Frame
    up to 60 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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