Multiple Myeloma Clinical Trial
— Bismuth-PBHOfficial title:
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy? A Clinical, Prospective, Randomized, Blinded Examination of Patients Suffering From Hematological Malignancies Treated With Intensive Chemotherapy and/or Radiotherapy.
The purpose of this study is to determine whether treatment with Bismuth can reduce the toxicity of chemotherapy and radiotherapy in patients with malignant diseases of the blood.
Status | Completed |
Enrollment | 50 |
Est. completion date | February 2013 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients of 18 years or over referred to the Department of Haematology L, Herlev Hospital, with a view to 'cytostatic'? treatment of or radiotherapy for haematological malignancy Exclusion Criteria: - Pregnant women and nursing mothers - No informed consent from patient - Known hyper sensitivity to bismuth or other tablet content - Severe renal insufficiency with creatinin clearance below 25 ml/min. - Patients receiving other treatment for protection of the mucous membrane except cryo treatment of the oral cavity (lumps of ice in the mouth) - Other experimental treatment within past four weeks. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Haematology L, Herlev Hospital, Herlev Ringvej 75 | Herlev |
Lead Sponsor | Collaborator |
---|---|
Copenhagen University Hospital at Herlev |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy | daily during treatment | No | |
Secondary | To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively | 6 months | No |
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