Agaricus Blazei Murill in Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Magnus Tangen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00970021
First received: September 1, 2009
Last updated: February 22, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Dietary Supplement: Intake of 60 ml placebo daily in addition to chemotherapy
Dietary Supplement: Intake of 60 ml agaricus daily in addition to chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of the Medicinal Mushroom Agaricus Blazei Murill in Addition to High Dose Chemotherapy in Patients With Multiple Myeloma.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Cytokine levels in serum [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: June 2009
Study Completion Date: February 2014
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Water with artificial colour
Placebo
Dietary Supplement: 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.
Other Name: Water with artificial colour
Active Comparator: Extract of agaricus blazei Murill
Agaricus blazei Murill
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
Other Name: Commercial name: AndoSan(TM)

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970021

Locations
Norway
Department of hematology, Oslo University Hospital, Ullevaal
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Principal Investigator: Jon-Magnus Tangen Department of Hematology, Oslo University Hospital, Ulleval
  More Information

No publications provided

Responsible Party: Jon Magnus Tangen, Senior Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00970021     History of Changes
Other Study ID Numbers: Ando-01
Study First Received: September 1, 2009
Last Updated: February 22, 2014
Health Authority: Norway: Ethics Committee

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2014