Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00892502

Acronym

Bismuth-PBH

Enrollment

Registered

2009-05-04

Start date

2009-05-31

Completion date

2013-02-28

Last updated

2013-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DRUGBismuth tablets

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

DRUGPlacebo tablets

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy	daily during treatment

Secondary

Measure	Time frame
To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively	6 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026