Agaricus Blazei Murill in Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00970021|
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : February 25, 2014
|Condition or disease||Intervention/treatment||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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Use of the Medicinal Mushroom Agaricus Blazei Murill in Addition to High Dose Chemotherapy in Patients With Multiple Myeloma.|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||February 2014|
Placebo Comparator: Water with artificial colour
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)
- Cytokine levels in serum [ Time Frame: 7 weeks ]
- Quality of Life [ Time Frame: 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970021
|Department of hematology, Oslo University Hospital, Ullevaal|
|Oslo, Norway, 0407|
|Principal Investigator:||Jon-Magnus Tangen||Department of Hematology, Oslo University Hospital, Ulleval|