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

This study is currently recruiting participants.
Verified December 2011 by Copenhagen University Hospital at Herlev
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00892502
First received: May 1, 2009
Last updated: December 9, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Hematological Diseases
Hematological Malignancies
Blood Diseases
Malignant Lymphoma
Leukemia
Multiple Myeloma
 Drug: Bismuth tablets
Drug: Placebo tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy [ Time Frame: daily during treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Bismuth tablets
 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 Comparator: 2
Placebo tablets, containing no active substance
 Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892502

Contacts
Contact: Per B Hansen, MD +4544883905 peboha01@heh.regionh.dk

Locations
Denmark
Department of Haematology L, Herlev Hospital, Herlev Ringvej 75 Recruiting
Herlev, Denmark, DK-2650
Principal Investigator: Per B Hansen, MD            
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Per B Hansen, MD Department of Haematology, Copenhagen University Hospital at Herlev
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT00892502     History of Changes
Other Study ID Numbers: 2007-007652-34
Study First Received: May 1, 2009
Last Updated: December 9, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Copenhagen University Hospital at Herlev:
haematology
haematological
hematology
hematological
malignancy
lymphoma
 myeloma
leukemia
blood diseases
malignant
bismuth

Additional relevant MeSH terms:
Neoplasms
Hematologic Diseases
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Neoplasms by Site
Bismuth
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013