Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?

NCT00892502 | Completed

• 1 other identifier: 2007-007652-34
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

haematology; haematological; hematology; hematological; malignancy; lymphoma; myeloma; leukemia; blood diseases; malignant; bismuth

Outcome Measures

Primary Outcomes (1)

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

  daily during treatment

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Bismuth tablets

Drug: Bismuth tablets

2

PLACEBO COMPARATOR

Placebo tablets, containing no active substance

Drug: Placebo tablets

Interventions

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

1

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

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Department of Haematology L, Herlev Hospital, Herlev Ringvej 75

Herlev, DK-2650, Denmark

Location

MeSH Terms

Conditions

Hematologic Diseases; Hematologic Neoplasms; Lymphoma; Leukemia; Multiple Myeloma; Neoplasms; Neoplasms, Plasma Cell

Interventions

Bismuth

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Neoplasms by Site; 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

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals

Study Officials

• Per B Hansen, MD

  Department of Haematology, Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: May 4, 2009
• Study Start: May 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2013
• Last Updated: September 10, 2013

Record last verified: 2013-09

Locations

DK (1)