LymphedemaBiobridgeNCT02734979
Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema
A study testing Biobridge and lymph node transfer in people with Lymphedema and Edema, run by Stanford University at 1 site in United States.
Trial summary
To investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphedema, Edema
- What is being tested?
- Biobridge and lymph node transfer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2016to 29 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The subject must be a breast cancer survivor, at least three years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention.
- Ages 18 to 75 years (inclusive).
- Swelling of 1 limb that is not completely reversed by elevation or compression
- Stage II or greater lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
- Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 8 weeks prior to screening, including use of compression garments for at least 8 weeks without change in regimen
- Willingness to maintain a stable regimen of self-care, with consistent use of compression garments from screening through the entire study duration (through the safety follow-up visit). Self-bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens must remain consistent from screening though the entire study duration.
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- Two consecutive measurements of limb volume (LV) in the affected limb taken at least 1 day apart during the screening period must be within 10% of each other. A maximum of 3 measurements can be taken. Affected limb volume ratio >20% (affected limb compared to unaffected limb); volume measurements will be performed and volume ratio will be calculated at S1 and S2 visit.
- Evidence of abnormal bioimpedance ratio, if feasible based upon unilateral disease: L-Dex >10 units; bioimpedance performed at S1 and S1
- Willingness and ability to understand and the willingness to sign a written informed consent form document
- Willingness and ability to comply with all study procedures, including measurement of skin thickness using skin calipers.
- Participants must have NED, completed breast cancer therapy 3 years prior to enrollment.
- ECOG 0- 2
Who cannot join
- Edema arising from increased capillary filtration will be excluded.
- Inability to safely undergo general anesthesia and/or perioperative care related to vascularized lymph node transfer
- Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening or 5 times the drug's half-life, whichever is longer
- Recent initiation of (≤8 weeks), or intention to initiate, CDPT or maintenance physiotherapy for lymphedema at any time during the duration of the study
- Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis
- Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion)
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- History of clotting disorder (hypercoagulable state)
- Chronic (persistent) infection in the affected limb
- Any other infection (unrelated to lymphedema) within 1 month prior to screening
- Current evidence of malignancy or any high risk for breast cancer recurrence (Stage III or IV, ER/PR/HER-2 negative (triple negative) cancer , locally advanced disease, inflammatory breast cancer, > 3 positive axillary lymph nodes, extracapsular nodal extension, invasive micropapillary breast carcinoma, or if performed, patients with a high risk of recurrence based on multi-gene signatures, e.g. BRCA1, BRCA 2, Oncotype DX (high risk recurrence score) or Mammaprint (poor risk signature)
- Currently receiving chemotherapy or radiation therapy
- Life expectancy < 2 years for any reason
- Pregnancy or nursing
- Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
- Significant or chronic renal insufficiency (defined as serum creatinine > 2.5 mg/dL or an estimated glomerular filtration rate [eGFR] < 30 mL/min at screening) or requires dialytic support
- Hepatic dysfunction, defined as alanine transaminase (ALT) or aspartate transaminase (AST) levels > 3 × upper limit of the normal range (ULN) and/or bilirubin level > 2 × ULN at screening
- Absolute neutrophil count < 1500 mm3 at screening
- Hemoglobin concentration < 9 g/dL at screening
- Known sensitivity to porcine products
- Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
To investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.
Read the detailed description
The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year following surgery to determine the success of the surgery. In addition, the volume of the operated arm will be monitored by repeated measurement with a tape measure. The investigators will also track bioimpedance, a painless technique to detect fluid in the tissues. The investigators will obtain small skin biopsies and blood samples to detect the biological changes that may occur as a result of successful surgery.
- Conditions
- Lymphedema, Edema
- Being tested
- Biobridge and lymph node transfer
- Keywords
- lymphedema, edema
- Medical subject headings
- Lymphedema, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobridge and lymph node transferDevice
Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery
| Study group | Role | What they receive |
|---|---|---|
| Biobridge and lymph node transfer | Experimental | The investigators will investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm. The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year following surgery to determine the success of the surgery. In addition, the volume of the operated arm will be monitored by repeated measurement with a tape measure. The investigators will also track bioimpedance, a painless technique to detect fluid in the tissues. The investigators will obtain small skin biopsies and blood samples to detect the biological changes that may occur as a result of successful surgery. Receives: Device: Biobridge and lymph node transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Limb Volume
Lymphoscintigraphy, a measure of limb volume indicative of adequate limb drainage, was conducted on the arm receiving BioBridge implantation (affected arm) and the contralateral (unaffected) arm, before surgery (baseline) and 1 year following surgical implantation of the Biobridge device. The outcome is reported as the median difference in the pre-implantation baseline value and the value 1 year after surgery for each arm.
Measured: 1 year
Secondary outcomes (5)
Serial Lymphoscintigraphy (LSG)
Lymphoscintigraphy, a measure of limb volume for which changes are indicative of adequate limb drainage, was conducted on the arm receiving the BioBridge implantation (baseline) and 1 year following the Biobridge implantation. The outcome is reported as the median difference in measured volume for affected arm from baseline to 1 year.
Measured: 1 year
Bioimpedance Spectroscopy
Bioimpedance spectroscopy (BIS) is a non-invasive technique to measure the volume of fluid in various parts of the body, and can be used to assess the extent of lymphedema. BIS involves passing an extremely low-strength electrical current through the area and measuring how the flow of the current is slowed by the fluid in the body, and is reported as Ri in ohms, meaning the resistance of the intracellular fluid. BIS was conducted on the arm with the BioBridge implant, at baseline and 1 year after surgery. The outcome is reported as the median difference between baseline and 1 year after surgery in the arm receiving the BioBridge implant.
Measured: 1 year
Caliper Skin-fold Thickness
Skin fold thickness as measured by calipers was used as a measure of fluid retention. Skin fold thickness was measured at the upper arm, forearm, and back of the hand, at baseline and at 1 year following surgical implantation of the Biobridge device. An increase in skin thickness means increased fluid retention. The outcome is reported as the median difference of skin fold thickness in millimeters (mm) for each location on the arm receiving the BioBridge implant, from baseline to 1 year.
Measured: 1 year
Cutaneous Punch Biopsy of Skin
Serial changes in histopathology will be determined via a blinded assessment of serial cutaneous punch biopsies specimens.
Measured: 1 year
Quality of Life for Limb Lymphoedema (LYMQOL)
Quality-of-life was assessed using the LYMQOL survey, a 5-question survey for improved function, appearance, symptoms, mood, and overall QOL. Overall QoL was reported on a 10-point scale with 10 being best, and the other assessments were for disease impact on a 4-point response scale consisting of 1 (none), 2 (a little), 3 (quite a bit), 4 (a lot), with lower values representing minimal disease (lymphedema) impact on the parameter and higher values representing a greater negative effect on the parameter. The outcome is reported as the median.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start20 Jul 2016
- Primary completion7 Jul 2018
- Study completion29 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanley Rockson, Stanford University
- Investigators
- Stanley G Rockson, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734979
- Sponsor's protocol ID
- IRB-37161
- Other IDs
- BRS0095
- Acronym
- Biobridge
- Status last verified
- Oct 2022
- First submitted
- 5 Apr 2016
- Last updated
- 27 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema
- ClinicalTrials.gov ID
- NCT02734979
- Acronym / sponsor ID
- Biobridge / IRB-37161
- Conditions
- Lymphedema, Edema
- Keywords
- lymphedema, edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Jul 2016 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 15 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.
Detailed description
The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year following surgery to determine the success of the surgery. In addition, the volume of the operated arm will be monitored by repeated measurement with a tape measure. The investigators will also track bioimpedance, a painless technique to detect fluid in the tissues. The investigators will obtain small skin biopsies and blood samples to detect the biological changes that may occur as a result of successful surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biobridge and lymph node transfer | Experimental | Device: Biobridge and lymph node transferThe investigators will investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm. The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year following surgery to determine the success of the surgery. In addition, the volume of the operated arm will be monitored by repeated measurement with a tape measure. The investigators will also track bioimpedance, a painless technique to detect fluid in the tissues. The investigators will obtain small skin biopsies and blood samples to detect the biological changes that may occur as a result of successful surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subject must be a breast cancer survivor, at least three years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention.
- Ages 18 to 75 years (inclusive).
- Swelling of 1 limb that is not completely reversed by elevation or compression
- Stage II or greater lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
- Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 8 weeks prior to screening, including use of compression garments for at least 8 weeks without change in regimen
Key exclusion criteria (20 listed)
- Edema arising from increased capillary filtration will be excluded.
- Inability to safely undergo general anesthesia and/or perioperative care related to vascularized lymph node transfer
- Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening or 5 times the drug's half-life, whichever is longer
- Recent initiation of (≤8 weeks), or intention to initiate, CDPT or maintenance physiotherapy for lymphedema at any time during the duration of the study
- Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis
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 |
|---|---|---|
| Biobridge and lymph node transferBiobridge is surgically implanted with conventional vascularized lymph node transfer surgery | Device | Biobridge and lymph node transfer |
Primary outcome
Change in Limb Volume
Time frame: 1 year
Lymphoscintigraphy, a measure of limb volume indicative of adequate limb drainage, was conducted on the arm receiving BioBridge implantation (affected arm) and the contralateral (unaffected) arm, before surgery (baseline) and 1 year following surgical implantation of the Biobridge device. The outcome is reported as the median difference in the pre-implantation baseline value and the value 1 year after surgery for each arm.
5 secondary outcomes
Serial Lymphoscintigraphy (LSG)
Time frame: 1 year
Bioimpedance Spectroscopy
Time frame: 1 year
Caliper Skin-fold Thickness
Time frame: 1 year
Cutaneous Punch Biopsy of Skin
Time frame: 1 year
Quality of Life for Limb Lymphoedema (LYMQOL)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Stanley G Rockson, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biobridge and lymph node transfer in people with Lymphedema and Edema, run by Stanford University at 1 site in United States.
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 12 inclusion and 20 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 27 Oct 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Limb Volume (time frame: 1 year). 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 27 Oct 2022.