search
Back to results

Agaricus Blazei Murill in Patients With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Intake of 60 ml placebo daily in addition to chemotherapy
Intake of 60 ml agaricus daily in addition to chemotherapy
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Department of hematology, Oslo University Hospital, Ullevaal

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Water with artificial colour

Extract of agaricus blazei Murill

Arm Description

Placebo

Agaricus blazei Murill

Outcomes

Primary Outcome Measures

Cytokine levels in serum

Secondary Outcome Measures

Quality of Life

Full Information

First Posted
September 1, 2009
Last Updated
February 22, 2014
Sponsor
Ullevaal University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00970021
Brief Title
Agaricus Blazei Murill in Patients With Multiple Myeloma
Official Title
Use of the Medicinal Mushroom Agaricus Blazei Murill in Addition to High Dose Chemotherapy in Patients With Multiple Myeloma.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ullevaal University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water with artificial colour
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Extract of agaricus blazei Murill
Arm Type
Active Comparator
Arm Description
Agaricus blazei Murill
Intervention Type
Dietary Supplement
Intervention Name(s)
Intake of 60 ml placebo daily in addition to chemotherapy
Other Intervention Name(s)
Water with artificial colour
Intervention Description
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
Intervention Name(s)
Intake of 60 ml agaricus daily in addition to chemotherapy
Other Intervention Name(s)
Commercial name: AndoSan(TM)
Intervention Description
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
Primary Outcome Measure Information:
Title
Cytokine levels in serum
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled to undergo high dose chemotherapy with autologous stem cell support for multiple myeloma Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon-Magnus Tangen
Organizational Affiliation
Department of Hematology, Oslo University Hospital, Ulleval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of hematology, Oslo University Hospital, Ullevaal
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
25664323
Citation
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.
Results Reference
derived

Learn more about this trial

Agaricus Blazei Murill in Patients With Multiple Myeloma

We'll reach out to this number within 24 hrs