Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?
NCT ID: NCT00892502
Last Updated: 2013-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2009-05-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Bismuth tablets
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
2
Placebo tablets, containing no active substance
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Copenhagen University Hospital at Herlev
OTHER
Responsible Party
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Principal Investigators
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Per B Hansen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Haematology, Copenhagen University Hospital at Herlev
Locations
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Department of Haematology L, Herlev Hospital, Herlev Ringvej 75
Herlev, , Denmark
Countries
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Other Identifiers
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2007-007652-34
Identifier Type: -
Identifier Source: org_study_id