Breast CancerNCT01954654
Effectiveness of Accelerated Intervention With Compression Sleeve in Mild and Moderate Breast Cancer-related Lymphedema
A study testing Custom-made compression sleeve and -gauntlet and Educational information, recommendation and instruction in people with Breast Cancer and Lymphedema, run by Mette Brodersen Jerver at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether accelerated treatment with custom-made compression sleeve is more effective than standard procedure in the treatment of mild and moderate arm lymphedema secondary to primary cancer treatment. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- Custom-made compression sleeve and -gauntlet and Educational information, recommendation and instruction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Apr 2015
- 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 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be refered for the first time due to unilateral arm lymphedema secondary to primary unilateral breast cancer treatment
- Participants must be ≥ 2 months after chemo- and radiotherapy
- Participants must have ELV ≥10% and < 30% and/or > 2 cm difference between the circumference of the two arms at minimum one circumference due to lymphedema
- Participants must be motivated for treatment with compression sleeve and -gauntlet
- Participants live in and around Aarhus, Denmark
Who cannot join
- Known metastatic disease
- Contraindication for treatment with compression sleeve
- Upper extremity deep venous thrombosis
- Previously use of compression sleeve
- Known contact allergy to latex
- Unable to fill in questionnaire and/or comply with treatment due to lacking Danish language skills, mental state or psychological condition
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital, Fysioterapi- og Ergoterapisfdelingen
Aarhus, Aarhus, 8000
Mette B Jerver, +45 78 46 22 10, Mette.Brodersen.jerver@auh.rm.dk
Mette B Jerver
About this study
Official title: Effectiveness of Accelerated Intervention With Custom-made Compression Sleeve in Women With Mild and Moderate Arm Lymphedema Secondary to Breast Cancer Treatment
The purpose of this study is to determine whether accelerated treatment with custom-made compression sleeve is more effective than standard procedure in the treatment of mild and moderate arm lymphedema secondary to primary cancer treatment.
Read the detailed description
Use of a custom-made compression sleeve is an initial treatment of mild and moderate arm lymphedema secondary to primary breast cancer treatment. The compression sleeve improves the flow of lymph fluid out of the arm, reduces the swelling, and prevents progression of the lymphedema in the future.
Early intervention is recommended though early is not well-defined in literature. The purpose of this study is to evaluate reduction of excess limb volume and changes in arm disability and clinical symptoms in accelerated treatment with compression sleeve compared to standard treatment.
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- Custom-made compression sleeve and -gauntlet, Educational information, recommendation and instruction
- 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.
Custom-made compression sleeve and -gauntletDevice
Also called Jobst Elvarex
Device: Compression garments worn for a minimum of six hours per day
Educational information, recommendation and instructionOther
Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow
| Study group | Role | What they receive |
|---|---|---|
| Accelerated treatment | Experimental | Not described Receives: Device: Custom-made compression sleeve and -gauntlet; Other: Educational information, recommendation and instruction |
| Standard treatment | Active comparator | Not described Receives: Device: Custom-made compression sleeve and -gauntlet; Other: Educational information, recommendation and instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of excess limb volume (ELV)
ELV in the affected arm compared to the non-affected arm. ELV described as both absolute volume in ml and relative volume in percent
Measured: 8 weeks follow-up
Secondary outcomes (2)
Changes in arm disability
Measured with Disabilities of Arm, Shoulder, and Hand (DASH)
Measured: 8 weeks follow-up
Changes in subjective symptoms (pain, tension, and heaviness)
Measured: 8 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mette Brodersen Jerver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mette Brodersen Jerver, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954654
- Sponsor's protocol ID
- 2007-58-0010
- Status last verified
- Oct 2013
- First submitted
- 29 Sep 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Accelerated Intervention With Custom-made Compression Sleeve in Women With Mild and Moderate Arm Lymphedema Secondary to Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT01954654
- Acronym / sponsor ID
- 2007-58-0010
- Conditions
- Breast Cancer, Lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Mette Brodersen JerverUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (estimated)
- First posted
- 7 Oct 2013 (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 accelerated treatment with custom-made compression sleeve is more effective than standard procedure in the treatment of mild and moderate arm lymphedema secondary to primary cancer treatment.
Detailed description
Use of a custom-made compression sleeve is an initial treatment of mild and moderate arm lymphedema secondary to primary breast cancer treatment. The compression sleeve improves the flow of lymph fluid out of the arm, reduces the swelling, and prevents progression of the lymphedema in the future.
Early intervention is recommended though early is not well-defined in literature. The purpose of this study is to evaluate reduction of excess limb volume and changes in arm disability and clinical symptoms in accelerated treatment with compression sleeve compared to standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated treatment | Experimental | Device: Custom-made compression sleeve and -gauntlet, Other: Educational information, recommendation and instruction |
| Standard treatment | Active comparator | Device: Custom-made compression sleeve and -gauntlet, Other: Educational information, recommendation and instruction |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be refered for the first time due to unilateral arm lymphedema secondary to primary unilateral breast cancer treatment
- Participants must be ≥ 2 months after chemo- and radiotherapy
- Participants must have ELV ≥10% and < 30% and/or > 2 cm difference between the circumference of the two arms at minimum one circumference due to lymphedema
- Participants must be motivated for treatment with compression sleeve and -gauntlet
- Participants live in and around Aarhus, Denmark
Key exclusion criteria (6 listed)
- Known metastatic disease
- Contraindication for treatment with compression sleeve
- Upper extremity deep venous thrombosis
- Previously use of compression sleeve
- Known contact allergy to latex
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 |
|---|---|---|
| Custom-made compression sleeve and -gauntletAlso: Jobst ElvarexDevice: Compression garments worn for a minimum of six hours per day | Device | Accelerated treatment, Standard treatment |
| Educational information, recommendation and instructionEducational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow | Other | Accelerated treatment, Standard treatment |
Primary outcome
Change of excess limb volume (ELV)
Time frame: 8 weeks follow-up
ELV in the affected arm compared to the non-affected arm. ELV described as both absolute volume in ml and relative volume in percent
2 secondary outcomes
Changes in arm disability
Time frame: 8 weeks follow-up
Changes in subjective symptoms (pain, tension, and heaviness)
Time frame: 8 weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-made compression sleeve and -gauntlet and Educational information, recommendation and instruction in people with Breast Cancer and Lymphedema, run by Mette Brodersen Jerver 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 5 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: status not confirmed, as of the sponsor's last update on 8 Oct 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mette B Jerver (+45 78 46 22 10, Mette.Brodersen.Jerver@auh.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of excess limb volume (ELV) (time frame: 8 weeks follow-up). 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 8 Oct 2013.