Back to resultsCan Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy? (Bismuth-PBH)
Primary Purpose
Hematological Diseases, Hematological Malignancies, Blood Diseases
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bismuth tablets
Placebo tablets
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Diseases focused on measuring haematology, haematological, hematology, hematological, malignancy, lymphoma, myeloma, leukemia, blood diseases, malignant, bismuth
Eligibility Criteria
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.
Sites / Locations
- Department of Haematology L, Herlev Hospital, Herlev Ringvej 75
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Bismuth tablets
Placebo tablets, containing no active substance
Outcomes
Primary Outcome Measures
To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy
Secondary Outcome Measures
To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively
Full Information
NCT ID
NCT00892502
First Posted
May 1, 2009
Last Updated
September 9, 2013
Sponsor
Copenhagen University Hospital at Herlev
1. Study Identification
Unique Protocol Identification Number
NCT00892502
Brief Title
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?
Acronym
Bismuth-PBH
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen University Hospital at Herlev
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Diseases, Hematological Malignancies, Blood Diseases, Malignant Lymphoma, Leukemia, Multiple Myeloma
Keywords
haematology, haematological, hematology, hematological, malignancy, lymphoma, myeloma, leukemia, blood diseases, malignant, bismuth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Bismuth tablets
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo tablets, containing no active substance
Intervention Type
Drug
Intervention Name(s)
Bismuth tablets
Intervention Description
1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy
Intervention Type
Drug
Intervention Name(s)
Placebo tablets
Intervention Description
1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy
Primary Outcome Measure Information:
Title
To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy
Time Frame
daily during treatment
Secondary Outcome Measure Information:
Title
To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per B Hansen, MD
Organizational Affiliation
Department of Haematology, Copenhagen University Hospital at Herlev
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Haematology L, Herlev Hospital, Herlev Ringvej 75
City
Herlev
ZIP/Postal Code
DK-2650
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?
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