Agaricus Blazei Murill in Patients With Multiple Myeloma
NCT ID: NCT00970021
Last Updated: 2014-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2009-06-30
2014-02-28
Brief Summary
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Detailed Description
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Primary endpoints will be cytokine levels of degree of activation of tumor supressor genes before and after start of the investigational product.
Secondary endpoints will be treatment response and quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Water with artificial colour
Placebo
Intake of 60 ml placebo daily in addition to chemotherapy
The patients will drink 60 ml of placebo daily from start of stem cell mobilizing treatment until one week after the end of aplasia after high dose melphalan. Duration of treatment is approximately 7 weeks.
Extract of agaricus blazei Murill
Agaricus blazei Murill
Intake of 60 ml agaricus daily in addition to chemotherapy
The patients will drink 60 ml of agaricus extract from the start of stem cell mobilizing treatment until one week after the end of aplasia after high dose melphalan. Duration of treatment: Approximately 7 weeks
Interventions
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Intake of 60 ml placebo daily in addition to chemotherapy
The patients will drink 60 ml of placebo daily from start of stem cell mobilizing treatment until one week after the end of aplasia after high dose melphalan. Duration of treatment is approximately 7 weeks.
Intake of 60 ml agaricus daily in addition to chemotherapy
The patients will drink 60 ml of agaricus extract from the start of stem cell mobilizing treatment until one week after the end of aplasia after high dose melphalan. Duration of treatment: Approximately 7 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Ullevaal University Hospital
OTHER
Responsible Party
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Jon Magnus Tangen
Senior Consultant
Principal Investigators
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Jon-Magnus Tangen
Role: PRINCIPAL_INVESTIGATOR
Department of Hematology, Oslo University Hospital, Ulleval
Locations
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Department of hematology, Oslo University Hospital, Ullevaal
Oslo, , Norway
Countries
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References
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Tangen JM, Tierens A, Caers J, Binsfeld M, Olstad OK, Troseid AM, Wang J, Tjonnfjord GE, Hetland G. Immunomodulatory effects of the Agaricus blazei Murrill-based mushroom extract AndoSan in patients with multiple myeloma undergoing high dose chemotherapy and autologous stem cell transplantation: a randomized, double blinded clinical study. Biomed Res Int. 2015;2015:718539. doi: 10.1155/2015/718539. Epub 2015 Jan 18.
Other Identifiers
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Ando-01
Identifier Type: -
Identifier Source: org_study_id
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