Agaricus Blazei Murill in Patients With Multiple Myeloma
Summary
Extract from the mushroom Agaricus blazeii 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.
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Multiple Myeloma
Intervention
Intake of 60 ml placebo daily in addition to chemotherapy, Intake of 60 ml agaricus daily in addition to chemotherapy
Location
Department of hematology, Oslo University Hospital, Ullevaal
Oslo
Norway
0407
Status
Recruiting
Source
Ullevaal University Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00970021
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Energy Intake
Total number of calories taken in daily whether ingested or by parenteral routes.
Diet Therapy
By adjusting the quantity and quality of food intake to improve health status of an individual. This term does not include the methods of food intake (NUTRITIONAL SUPPORT).
Protein-energy Malnutrition
The lack of sufficient energy or protein to meet the body's metabolic demands, as a result of either an inadequate dietary intake of protein, intake of poor quality dietary protein, increased demands due to disease, or increased nutrient losses.
Postprandial Period
The time frame after a meal or FOOD INTAKE.
Monitoring, Ambulatory
The use of electronic equipment to observe or record physiologic processes while the patient undergoes normal daily activities.
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