Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy? (Bismuth-PBH)

Copenhagen University Hospital at Herlev

Status: Completed

Conditions: Multiple Myeloma; Hematological Malignancies; Malignant Lymphoma; Hematological Diseases; Leukemia; Blood Diseases

Treatments: Drug: Placebo tablets; Drug: Bismuth tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT00892502

2007-007652-34

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Bismuth tablets

Treatment:

Drug: Bismuth tablets

2

Placebo Comparator group

Description:

Placebo tablets, containing no active substance

Treatment:

Drug: Placebo tablets