Breast NeoplasmsPhase 2NCT00188604
The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer
A Phase 2 study testing sodium selenite in people with Breast Neoplasms and Lymphedema, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The primary objective of this study to assess the effectiveness of selenium compared to placebo in reducing the lymphedema in-patients with breast cancer. Secondary objectives are to assess the impact of selenium on patient's quality of life and to assess the incidence of adverse effects of selenium therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Lymphedema
- What is being tested?
- sodium selenite
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2004to Jan 2009
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with clinically documented lymphedema of upper limb secondary to breast cancer management (surgery - axillary nodal dissection, and radiotherapy)
- patients who have had other modalities of management can be included, e.g. physical therapy, pharmacological therapy
- ECOG performance 0-2
- informed consent
Who cannot join
- active cellulitis/skin infection of the limb
- venous thrombosis of the upper limbs
- active malignancy
- any other medical condition or congenital or traumatic injury involving either limb
- patients already on selenium medication
- patients participating in another clinical study related to lymphedema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients
The primary objective of this study to assess the effectiveness of selenium compared to placebo in reducing the lymphedema in-patients with breast cancer. Secondary objectives are to assess the impact of selenium on patient's quality of life and to assess the incidence of adverse effects of selenium therapy.
- Conditions
- Breast Neoplasms, Lymphedema
- Being tested
- sodium selenite
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium seleniteDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of orally administered selenium compared to placebo in reducing arm lymphedema in patients treated with surgery (axiallary nodal dissection) and radiotherapy for breast cancer.
Secondary outcomes (2)
To assess the toxicity of selenium.
To assess the association of selenium, quality of life and limb function.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Investigators
- Wilfred Levin, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188604
- Sponsor's protocol ID
- UHN REB 03-0741-C
- Status last verified
- Aug 2010
- First submitted
- 12 Sep 2005
- Last updated
- 13 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00188604
- Acronym / sponsor ID
- UHN REB 03-0741-C
- Conditions
- Breast Neoplasms, Lymphedema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Jan 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Sep 2005 (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 primary objective of this study to assess the effectiveness of selenium compared to placebo in reducing the lymphedema in-patients with breast cancer. Secondary objectives are to assess the impact of selenium on patient's quality of life and to assess the incidence of adverse effects of selenium therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with clinically documented lymphedema of upper limb secondary to breast cancer management (surgery - axillary nodal dissection, and radiotherapy)
- patients who have had other modalities of management can be included, e.g. physical therapy, pharmacological therapy
- ECOG performance 0-2
- informed consent
Key exclusion criteria (6 listed)
- active cellulitis/skin infection of the limb
- venous thrombosis of the upper limbs
- active malignancy
- any other medical condition or congenital or traumatic injury involving either limb
- patients already on selenium medication
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 |
|---|---|---|
| sodium selenite | Drug | – |
Primary outcome
To assess the effectiveness of orally administered selenium compared to placebo in reducing arm lymphedema in patients treated with surgery (axiallary nodal dissection) and radiotherapy for breast cancer.
2 secondary outcomes
To assess the toxicity of selenium.
To assess the association of selenium, quality of life and limb function.
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 13 Aug 2010.
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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.
Wilfred Levin, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sodium selenite in people with Breast Neoplasms and Lymphedema, run by University Health Network, Toronto at 1 site in Canada.
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 4 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 13 Aug 2010. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 assess the effectiveness of orally administered selenium compared to placebo in reducing arm lymphedema in patients treated with surgery (axiallary nodal dissection) and radiotherapy for breast cancer.. 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 13 Aug 2010.