Agaricus Blazei Murill in Patients With Multiple Myeloma

NCT00970021 | Completed Phase 2

• 1 other identifier: Ando-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Cytokine levels in serum

  7 weeks

Secondary Outcomes (1)

• Quality of Life

  4 months

Study Arms (2)

Water with artificial colour

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Intake of 60 ml placebo daily in addition to chemotherapy

Extract of agaricus blazei Murill

ACTIVE COMPARATOR

Agaricus blazei Murill

Dietary Supplement: Intake of 60 ml agaricus daily in addition to chemotherapy

Interventions

Intake of 60 ml placebo daily in addition to chemotherapy 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.

Also known as: Water with artificial colour

Water with artificial colour

Intake of 60 ml agaricus daily in addition to chemotherapy 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

Also known as: Commercial name: AndoSan(TM)

Extract of agaricus blazei Murill

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Ullevaal University Hospital: lead

Study Sites (1)

Department of hematology, Oslo University Hospital, Ullevaal

Oslo, 0407, Norway

Location

Related Publications (1)

• 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.

  PMID: 25664323 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Water

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Jon-Magnus Tangen

  Department of Hematology, Oslo University Hospital, Ulleval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: February 1, 2014
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

NO (1)