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Sponsored by: |
Copenhagen University Hospital at Herlev |
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Information provided by: | Copenhagen University Hospital at Herlev |
ClinicalTrials.gov Identifier: | NCT00892502 |
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.
Condition | Intervention |
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Hematological Diseases Hematological Malignancies Blood Diseases Malignant Lymphoma Leukemia Multiple Myeloma |
Drug: Bismuth tablets Drug: Placebo tablets |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Official 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. |
Estimated Enrollment: | 50 |
Study Start Date: | May 2009 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Bismuth tablets
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Drug: Bismuth tablets
1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy
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2: Placebo Comparator
Placebo tablets, containing no active substance
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Drug: Placebo tablets
1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Per B Hansen, MD | +4544883905 | peboha01@heh.regionh.dk |
Denmark | |
Department of Haematology L, Herlev Hospital, Herlev Ringvej 75 | Recruiting |
Herlev, Denmark, DK-2650 | |
Principal Investigator: Per B Hansen, MD |
Principal Investigator: | Per B Hansen, MD | Department of Haematology, Copenhagen University Hospital at Herlev |
Responsible Party: | Department of Haematology, Copenhagen University Hospital at Herlev ( Per Boye Hansen, MD ) |
Study ID Numbers: | 2007-007652-34 |
Study First Received: | May 1, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00892502 History of Changes |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
haematology haematological hematology hematological malignancy lymphoma |
myeloma leukemia blood diseases malignant bismuth |
Immunoproliferative Disorders Hematologic Neoplasms Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders Bismuth |
Multiple Myeloma Leukemia Lymphatic Diseases Hemorrhagic Disorders Antacids Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Hematologic Neoplasms Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias Hemostatic Disorders Pharmacologic Actions Bismuth |
Multiple Myeloma Leukemia Lymphatic Diseases Neoplasms Neoplasms by Site Hemorrhagic Disorders Antacids Cardiovascular Diseases Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |