Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Hematological Diseases, Hematological Malignancies, Blood Diseases, Malignant Lymphoma, Leukemia, Multiple Myeloma

Intervention / Treatment
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* Drug: Bismuth tablets
* Drug: Placebo tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Bismuth tablets | Drug: Bismuth tablets<br>* 1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy<br>|
| Placebo Comparator: 2<br>Placebo tablets, containing no active substance | Drug: Placebo tablets<br>* 1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy |  | daily during treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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haematology, haematological, hematology, hematological, malignancy, lymphoma, myeloma, leukemia, blood diseases, malignant, bismuth