Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy
Outcome Time Frame:
daily during treatment
Safety Issue:
No
Principal Investigator
Per B Hansen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Haematology, Copenhagen University Hospital at Herlev
Authority:
Denmark: The Danish National Committee on Biomedical Research Ethics
Study ID:
2007-007652-34
NCT ID:
NCT00892502
Start Date:
May 2009
Completion Date:
February 2013
Related Keywords:
- Hematological Diseases
- Hematological Malignancies
- Blood Diseases
- Malignant Lymphoma
- Leukemia
- Multiple Myeloma
- haematology
- haematological
- hematology
- hematological
- malignancy
- lymphoma
- myeloma
- leukemia
- blood diseases
- malignant
- bismuth
- Neoplasms
- Hematologic Diseases
- Leukemia
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Hematologic Neoplasms