Hematological DiseasesBismuth-PBHNCT00892502
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?
A study testing Bismuth tablets in people with Hematological Diseases and Hematological Malignancies, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematological Diseases, Hematological Malignancies, Blood Diseases
- What is being tested?
- Bismuth tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- May 2009to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Haematology L, Herlev Hospital, Herlev Ringvej 75
Herlev, DK-2650
About this study
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.
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
- Being tested
- Bismuth tablets, Placebo tablets
- Keywords
- haematology, haematological, hematology, hematological, malignancy, lymphoma, myeloma, leukemia, blood diseases, malignant, bismuth
- Medical subject headings
- Hematologic Diseases, Hematologic Neoplasms, Lymphoma, Leukemia, Multiple Myeloma, Neoplasms, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bismuth tabletsDrug
1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy
Placebo tabletsDrug
1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bismuth tablets Receives: Drug: Bismuth tablets |
| 2 | Placebo comparator | Placebo tablets, containing no active substance Receives: Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy
Measured: daily during treatment
Secondary outcomes (1)
To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per B Hansen, MD, Principal investigator, Department of Haematology, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892502
- Sponsor's protocol ID
- 2007-007652-34
- Acronym
- Bismuth-PBH
- Status last verified
- Sep 2013
- First submitted
- 1 May 2009
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00892502
- Acronym / sponsor ID
- Bismuth-PBH / 2007-007652-34
- Conditions
- Hematological Diseases, Hematological Malignancies, Blood Diseases, Malignant Lymphoma, Leukemia, Multiple Myeloma
- Keywords
- haematology, haematological, hematology, hematological, malignancy, lymphoma, myeloma, leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Bismuth tabletsBismuth tablets |
| 2 | Placebo comparator | Drug: Placebo tabletsPlacebo tablets, containing no active substance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bismuth tablets1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy | Drug | 1 |
| Placebo tablets1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy | Drug | 2 |
Primary outcome
To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy
Time frame: daily during treatment
1 secondary outcome
To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per B Hansen, MD principal investigator
Department of Haematology, Copenhagen University Hospital at Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bismuth tablets in people with Hematological Diseases and Hematological Malignancies, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy (time frame: daily during treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.