Can Treatment With Bismuth Reduce Toxicity to Chemotherap... | NCT00892502

Studies
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?

NCT00892502

Sponsor

Copenhagen University Hospital at Herlev

Status

Completed

Last Update Posted

Sep 10, 2013Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Hematological Diseases
Hematological Malignancies
Blood Diseases
Malignant Lymphoma
Leukemia
Multiple Myeloma

Interventions

Bismuth tablets
Placebo tablets

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Feb 2013Actual

First Submitted Date

May 1, 2009

First Submission Date that Met QC Criteria

May 1, 2009

First Posted Date

May 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2013

Last Update Posted Date

Sep 10, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Bismuth tablets	Drug: Bismuth tablets
2	Placebo Comparator	Placebo tablets, containing no active substance	Drug: Placebo tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Per B Hansen, MD	Department of Haematology, Copenhagen University Hospital at Herlev	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Haematology L, Herlev Hospital, Herlev Ringvej 75		Herlev		DK-2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006402	Hematologic Diseases
D019337	Hematologic Neoplasms
D008223	Lymphoma
D007938	Leukemia
D009101	Multiple Myeloma
D009369	Neoplasms
D054219	Neoplasms, Plasma Cell

Ancestor Terms

ID	Term
D006425	Hemic and Lymphatic Diseases
D009371	Neoplasms by Site
D009370	Neoplasms by Histologic Type
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001729	Bismuth

Ancestor Terms

ID	Term
D004603	Elements, Radioactive
D004602	Elements
D007287	Inorganic Chemicals
D019216	Metals, Heavy

Browse Leaves

Not provided

Browse Branches

Not provided