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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00892502
Other study ID # 2007-007652-34
Secondary ID
Status Completed
Phase N/A
First received May 1, 2009
Last updated September 9, 2013
Start date May 2009
Est. completion date February 2013

Study information

Verified date September 2013
Source Copenhagen University Hospital at Herlev
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

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
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

Locations

Country Name City State
Denmark Department of Haematology L, Herlev Hospital, Herlev Ringvej 75 Herlev

Sponsors (1)

Lead Sponsor Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

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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