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Completed

NCT Number: NCT00892502

Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?

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.

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Key information

Conditions

Hematological Diseases Blood Diseases Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hematologic Neoplasms Hematological Malignancies Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Malignant Lymphoma Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Haematology L, Herlev Hospital, Herlev Ringvej 75

Herlev, DK-2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bismuth tablets

Drug

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

Drug

1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy

Primary outcomes

  1. To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy

    Time frame: daily during treatment

Secondary outcomes

  1. To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Registry information

Official study title

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.

Acronym: Bismuth-PBH

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
May 4, 2009
Registry last updated
Sep 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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