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Trial record 1 of 1 for:    NCT02734979
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Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema (Biobridge)

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ClinicalTrials.gov Identifier: NCT02734979
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphedema Edema Device: Biobridge and lymph node transfer Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema
Actual Study Start Date : July 20, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: Biobridge and lymph node transfer
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.
Device: Biobridge and lymph node transfer
Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery




Primary Outcome Measures :
  1. Limb volume reduction [ Time Frame: 1 year ]
    Quantitative reduction in volume of the treated limb will be assessed by measuring limb circumference. The outcome will be reported as a mean change in limb volume of of affected and non-affected limbs.


Secondary Outcome Measures :
  1. Serial lymphoscintigraphy (LSG) [ Time Frame: 1 year ]
    Quantitative changes in axillary lymph node function and transit times on serial lymphoscintigraphy will be serially assessed

  2. Bioimpedance spectroscopy [ Time Frame: 1 year ]
    Serial changes in bioimpedance spectroscopy will be quantitated

  3. Caliper skin fold thickness [ Time Frame: 1 year ]
    Serial changes in caliper skin fold thickness will be quantitated

  4. Cutaneous punch biopsy of skin [ Time Frame: 1 year ]
    Serial changes in histopathology will be assessed with serial cutaneous punch biopsy

  5. Quality of life measure for limb lymphoedema (LYMQOL) [ Time Frame: 1 year ]
    Quality of life parameters will be measured using LYMQOL survey. Questions in the survey cover four areas: symptoms, body image/appearance, function and mood. Answers are scored 1-4 (less severe to severe)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.
  • 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

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734979


Contacts
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Contact: Leslie Roche, RN 659-723-1396 lesroche@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Leslie Roche, RN       lesroche@stanford.edu   
Principal Investigator: Stanley G Rockson, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Stanley G Rockson, MD Stanford University

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Responsible Party: Stanley Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02734979     History of Changes
Other Study ID Numbers: IRB-37161
BRS0095 ( Other Identifier: OnCore )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Stanley Rockson, Stanford University:
lymphedema
edema
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases