Use of the Medicinal Mushroom Agaricus Blazei Murill in Addition to High Dose Chemotherapy in Patients With Multiple Myeloma.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Locations
- 2
- Primary Endpoint
- Cytokine levels in serum
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients scheduled to undergo high dose chemotherapy with autologous stem cell support for multiple myeloma
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cytokine levels in serum
Time Frame: 7 weeks
Secondary Outcomes
- Quality of Life(4 months)
Investigators
Jon Magnus Tangen
Senior Consultant
Oslo University Hospital