Agaricus Blazei Murill in Patients With Multiple Myeloma

NCT ID: NCT00970021

Last Updated: 2014-02-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-02-28

Brief Summary

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Extract from the mushroom Agaricus blazei Murill har been shown to have strong immunomodulating properties both in cell cultures, animal models and in humans. Furthermore antitumor properties have been shown in animal models, among them in mice with multiple myeloma. The investigators now want to investigate the effect of Agaricus as supplementary treatment in addition to chemotherapy in patients with multiple myeloma.

Detailed Description

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Patients who are scheduled to undergo high dose chemotherapy for multiple myeloma will receive in addition in a double blinded manner 60 ml of agaricus extract or placebo once daily from the start of stem cell mobilizing therapy until one week after the end of aplasia after high dose melphalan.

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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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Water with artificial colour

Placebo

Group Type PLACEBO_COMPARATOR

Intake of 60 ml placebo daily in addition to chemotherapy

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

Intake of 60 ml agaricus daily in addition to chemotherapy

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Water with artificial colour Commercial name: AndoSan(TM)

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to undergo high dose chemotherapy with autologous stem cell support for multiple myeloma

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jon Magnus Tangen

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Norway

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.

Reference Type DERIVED
PMID: 25664323 (View on PubMed)

Other Identifiers

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Ando-01

Identifier Type: -

Identifier Source: org_study_id

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