Secondary LymphedemaNCT03578380
Supermicrosurgery for Breast Cancer Survivors With Lymphedema.
A study testing Surgery and Compression and drainage therapy in people with Secondary Lymphedema and Breast Cancer, run by Sykehuset Telemark at 1 site in Norway.
Trial summary
A randomised prospective investigation of volume and quality of life results with lymphovenous anastomosis in patients with unilateral arm lymphedema after breast cancer using Indocyanine Green lymphangiography and MD Anderson Staging. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Secondary Lymphedema, Breast Cancer
- What is being tested?
- Surgery and Compression and drainage therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 26 Jan 2016to 31 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Unilateral lymphedema of the arm secondary to breast cancer treatment. Stage 1-3 operable lymphedema.
Who cannot join
- Frequent or severe cellulitis. All other lymphedema.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Sykehuset Telemark
Skien, Telemark, NO-3710
About this study
Official title: Supermicrosurgery for Breast Cancer Survivors With Lymphedema. -Prospective Randomized Clinical and Patient-reported Outcomes.
A randomised prospective investigation of volume and quality of life results with lymphovenous anastomosis in patients with unilateral arm lymphedema after breast cancer using Indocyanine Green lymphangiography and MD Anderson Staging.
Read the detailed description
This is a randomized study comparing lymphovenous anastomosis versus conservative (compression) treatment for lymphoedema after breast cancer surgery - 50 patients to be included in each study arm. The primary endpoint is volume change measured by submersion and changes in arm circumference at defined levels from the wrist. Secondary endpoint is health related quality of life measured by questionnaire Short Form 36 (SF-36), Hospital Anxiety Depression Score (HADS), Fatigue Questionnaire (FQ) and a disease-specific questionnaire, Upper Limb Lymphedema score (ULL27).
- Conditions
- Secondary Lymphedema, Breast Cancer
- Being tested
- Surgery, Compression and drainage therapy
- Keywords
- Lymphovenous bypass, Lymphovenous anastomosis, Supermicrosurgery, Lymphangiography, MD Anderson Lymphedema Stage
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Lymphovenous anastomosis
Compression and drainage therapyOther
Treatment with compression stockings and manual drainage (massage therapy)
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Lymphovenous anastomosis Receives: Procedure: Surgery |
| Compression | Active comparator | Conservative treatment with physiotherapy and compression Receives: Other: Compression and drainage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume
Volume of arm as described by submersion and circumference measures
Measured: 12 months
Secondary outcomes (1)
Health related quality of life ULL27
To be measured by questionnaire "Upper Limb Lymphedema score 27" (ULL27) by Professor Robert Launois at REES France. The scale measures health related quality of life in patients with upper limb lymphedema.
Construction: 27 questions rated from 1 (lowest quality of life) to 5 highest quality of life.
Dimensions: There are 3 dimensions assessing symptoms, self value, everyday social life. Total score 27-135 Symptom score: 18-90 Self value: 5-25 Social life: 4-20 Question 20 and 22 are part of the self value dimension and are control questions with reverse scores, i.e 1 represents highest quality of life and 5 represents lowest quality of life. The scores for question 20 and 22 are later reversed when adding the total score.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start26 Jan 2016
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary LymphedemaStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- University of Oslo, Ohio State University
- Responsible party
- Sponsor
- Investigators
- Lars Johan Sandberg, MD, Principal investigator, Sykehuset Telemark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578380
- Sponsor's protocol ID
- Prosjektnr 1097.19
- Status last verified
- Dec 2022
- First submitted
- 12 Jun 2017
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supermicrosurgery for Breast Cancer Survivors With Lymphedema. -Prospective Randomized Clinical and Patient-reported Outcomes.
- ClinicalTrials.gov ID
- NCT03578380
- Acronym / sponsor ID
- Prosjektnr 1097.19
- Conditions
- Secondary Lymphedema, Breast Cancer
- Keywords
- Lymphovenous bypass, Lymphovenous anastomosis, Supermicrosurgery, Lymphangiography, MD Anderson Lymphedema Stage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- University of Oslo, Ohio State University
- Study start
- 26 Jan 2016 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jul 2018 (actual)
- 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.
A randomised prospective investigation of volume and quality of life results with lymphovenous anastomosis in patients with unilateral arm lymphedema after breast cancer using Indocyanine Green lymphangiography and MD Anderson Staging.
Detailed description
This is a randomized study comparing lymphovenous anastomosis versus conservative (compression) treatment for lymphoedema after breast cancer surgery - 50 patients to be included in each study arm. The primary endpoint is volume change measured by submersion and changes in arm circumference at defined levels from the wrist. Secondary endpoint is health related quality of life measured by questionnaire Short Form 36 (SF-36), Hospital Anxiety Depression Score (HADS), Fatigue Questionnaire (FQ) and a disease-specific questionnaire, Upper Limb Lymphedema score (ULL27).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: SurgeryLymphovenous anastomosis |
| Compression | Active comparator | Other: Compression and drainage therapyConservative treatment with physiotherapy and compression |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral lymphedema of the arm secondary to breast cancer treatment. Stage 1-3 operable lymphedema.
Key exclusion criteria (1 listed)
- Frequent or severe cellulitis. All other lymphedema.
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 |
|---|---|---|
| SurgeryLymphovenous anastomosis | Procedure or surgery | Surgery |
| Compression and drainage therapyTreatment with compression stockings and manual drainage (massage therapy) | Other | Compression |
Primary outcome
Volume
Time frame: 12 months
Volume of arm as described by submersion and circumference measures
1 secondary outcome
Health related quality of life ULL27
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers
Related trials for Secondary Lymphedema
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Use of Reconstructive Microsurgery for the Treatment of Lymphedema
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mRNA Therapy to Restore Lymphatic Flow in Secondary Lymphedema
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Biological Profile of Primary and Secondary Lymphedema: Inflammatory, Endothelial, Metabolic, Lymphatic, and Fibrotic Markers
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RecruitingPhase 2
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
Breast Cancer, Axillary Nodal Disease
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.
Lars Johan Sandberg, MD principal investigator
Sykehuset Telemark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and Compression and drainage therapy in people with Secondary Lymphedema and Breast Cancer, run by Sykehuset Telemark at 1 site in Norway.
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 1 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 18 Apr 2023. 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 Norway. 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 Lars Johan Sandberg, MD (+4735003456, johansandberg@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume (time frame: 12 months). 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 18 Apr 2023.