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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.


N/A
18 Years
75 Years
Open (Enrolling)
Both
Hematological Diseases, Hematological Malignancies, Blood Diseases, Malignant Lymphoma, Leukemia, Multiple Myeloma

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

daily during treatment

Safety Issue:

No

Principal Investigator

Per B Hansen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Haematology, Copenhagen University Hospital at Herlev

Authority:

Denmark: The Danish National Committee on Biomedical Research Ethics

Study ID:

2007-007652-34

NCT ID:

NCT00892502

Start Date:

May 2009

Completion Date:

February 2013

Related Keywords:

  • Hematological Diseases
  • Hematological Malignancies
  • Blood Diseases
  • Malignant Lymphoma
  • Leukemia
  • Multiple Myeloma
  • haematology
  • haematological
  • hematology
  • hematological
  • malignancy
  • lymphoma
  • myeloma
  • leukemia
  • blood diseases
  • malignant
  • bismuth
  • Neoplasms
  • Hematologic Diseases
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

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