Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?

Multiple Myeloma Clinical Trial

— Bismuth-PBH  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892502
• Other study ID #: 2007-007652-34
• Status: Completed
• Phase: N/A
• First received: May 1, 2009
• Last updated: September 9, 2013
• Start date: May 2009
• Est. completion date: February 2013

Study information

• Verified date: September 2013
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Diseases
• Hematologic Diseases
• Hematological Diseases
• Hematological Malignancies
• Leukemia
• Lymphoma
• Malignant Lymphoma
• Multiple Myeloma
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Haematology L, Herlev Hospital, Herlev Ringvej 75	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy		daily during treatment	No
Secondary	To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively		6 months	No