Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?

Not Applicable

Completed

• Conditions: Hematological Diseases; Hematological Malignancies; Blood Diseases; Malignant Lymphoma; Leukemia; Multiple Myeloma
• Interventions: Drug: Placebo tablets; Drug: Bismuth tablets

• Registration Number: NCT00892502
• Lead Sponsor: Copenhagen University Hospital at Herlev

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-01
• Study First Submitted QC: 2009-05-01
• Study First Posted: 2009-05-04
• Primary Completion: 2012-01
• Study Completion: 2013-02
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-09
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo tablets	Placebo tablets, containing no active substance
1	Bismuth tablets	Bismuth tablets

Primary Outcome Measures

Name	Time	Method
To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy	daily during treatment

Secondary Outcome Measures

Name	Time	Method
To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively	6 months

Trial Locations

Locations (1)

Department of Haematology L, Herlev Hospital, Herlev Ringvej 75; 🇩🇰 Herlev, Denmark