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Prophylactic LYMphatic Reconstruction (LYMbR) to Prevent Lymphedema After Node Dissection for Cutaneous Malignancies (LYMbR)

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ClinicalTrials.gov Identifier: NCT05136079
Recruitment Status : Not yet recruiting
First Posted : November 26, 2021
Last Update Posted : November 26, 2021
Sponsor:
Collaborators:
University of Calgary
Tom Baker Cancer Centre
Information provided by (Responsible Party):
Claire Temple-Oberle, Alberta Health Services, Calgary

Brief Summary:

Background: Lymphedema following lymph node dissection is a chronic condition that can limit physical, occupational, and social participation, impact self-image, and result in financial burden. Studies have reported lymphedema incidence rates of 39% to 73% following node dissection.

Lymphaticovenous anastomosis (LVA) has been previously used to treat established lymphedema. More recently, with imaging capabilities guided by blue dye and indocyanine green dye, the possibility of prophylactic LVA has become feasible. A 2018 systematic review of 12 studies utilizing prophylactic LVA during lymphadenectomy indicated a 2/3 reduction in the risk of lymphedema. The literature yet lacks any phase III studies with stringent controls and long term follow-up.

Objectives: To assess (primary endpoint) the impact of prophylactic LVA on presence or absence of lymphedema post axillary or groin lymphadenectomy and participant quality of life. To assess (secondary endpoint) the incidence of complications related to nodal dissection.

Methods: This is a phase III RCT, block randomized for upper and lower extremities, recruiting adult patients planned for an axillary or groin node dissection as a result of cutaneous malignancy. Analysis of rates of lymphedema and quality of life reports will be done.

Significance: Lymphedema is a feared outcome of surgical cancer care. Its impact on patients' daily lives is profound. A reduction of incidence of this debilitating condition by 2/3 would have significant impact on numerous lives and could also reduce the health system resources needed for its management.


Condition or disease Intervention/treatment Phase
Lymphedema of Limb Malignant Skin Neoplasm Procedure: Prophylactic lymphaticonvenous anastomosis Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A total of 40 study participants will be block (axilla, groin) randomized using 2 equal groups (control/intervention) of 20 participants each.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Participant: Participants will not be informed of their study arm allocation until they complete the study. Regardless of study arm, participants will be injected with the requisite blue dye to perform the LVA procedures, thereby providing no visible clue as to whether they are control or intervention participants. The exception will be in the case where a participant is diagnosed with lymphedema post-operatively but prior to their study participation completion and their healthcare management requires knowledge of surgical history.

Radiologist: At 24 months each participant will undergo a radionuclide lymphoscintigraphy to assess the functioning of the lymphatic system. The radiologist reading the results will be blinded as to the participants' study allocation.

Primary Purpose: Prevention
Official Title: Prophylactic LYMphatic Reconstruction (LYMbR) to Prevent Lymphedema
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: Prophylactic lymphaticovenous anastomosis
Intervention participants will undergo prophylactic lymphaticovenous anastomosis as an addendum to axillary or ilioinguinal lymphadenectomy for treatment of cutaneous malignancy.
Procedure: Prophylactic lymphaticonvenous anastomosis
Prophylactic lymphaticovenous anastomosis is an immediate prophylactic approach whereby the lymphaticovenous anastomosis is performed at the time of nodal dissection utilizing fluorescing indocynanine green (ICG) and an operating microscope.

No Intervention: Lymphadenectomy without lymphaticovenous anastomosis
Control participants will undergo axillary or ilioinguinal lymphadenectomy without lymphaticovenous anastomosis for treatment of cutaneous malignancy .



Primary Outcome Measures :
  1. Presence or absence of lymphedema at 24 months post axillary or groin lymphadenectomy as assessed by limb volume over time. [ Time Frame: 24 months ]
    Using a non-stretch measuring tape, circumferential measurements at 4cm intervals along the length of the contralateral limbs will be taken pre-surgery (baseline) and at 24 months. Limb volumes will be calculated. In the limb impacted by surgery, a 10% increase in volume from baseline to 24 months will be indicative of the development of lymphedema. In the case of significant weight gain or loss, comparison with the volume of the contralateral limb will also be used to evaluate presence of lymphedema in the surgical limb.

  2. Quality of life impact as measured by LYMQOL PROM [ Time Frame: 24 months ]
    A lymphedema quality of life patient reported outcome measure with specific arm and leg questionnaires called the LYMQOL will be used to measure quality of life. The scale uses a 4 point system for the majority of questions wherein a higher score indicates that lymphedema is having a greater negative impact on quality of life. A single final question uses a 10 point scale (poor to excellent) to rate one's quality of life overall with a higher score indicating greater quality of life. Comparison of quality of life scoring from baseline (pre-surgery) with scoring at 24 months post-surgery.


Secondary Outcome Measures :
  1. Incidence of evidence of acute post-operative surgical complications [ Time Frame: 24 months ]
    Diagnosis of complications such as cellulitis, dehiscence, lymphocele, and/or prolonged need for drain over 30days



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

Inclusion Criteria:

  • Adult persons (>18 years of age) undergoing axilla or groin lymphadenectomy as part of cutaneous malignancy management.

Exclusion Criteria:

  • Patients receiving a sentinel lymph node biopsy alone
  • Patients with untreated in-transit disease on the upper or lower extremities
  • Patients with established preoperative lymphedema
  • Patients with post-thrombotic syndrome
  • Pregnant patients
  • Patients with a previous history of radiation therapy to the affected nodal basin or extremity

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): NCT05136079


Contacts
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Contact: Carmen Webb, MA 403-521-3012 carmen.webb@ahs.ca

Locations
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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Contact: Carmen Webb, MA    403-521-3012    carmen.webb@ahs.ca   
Sponsors and Collaborators
Alberta Health Services, Calgary
University of Calgary
Tom Baker Cancer Centre
Investigators
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Principal Investigator: Claire Temple-Oberle, MD, MSc, FRCSC, MMEd University of Calgary
Publications:
Campanholi LL, Duprat JP, Fregnani JHTG. Incidence of le due to treating cutaneous melanoma. J Lymphoedema. 2011; 16(1): 30-34.

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Responsible Party: Claire Temple-Oberle, Surgeon, Departments of Surgery and Oncology; Professor - University of Calgary, Alberta Health Services, Calgary
ClinicalTrials.gov Identifier: NCT05136079    
Other Study ID Numbers: PLVA-2021
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
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: No
Additional relevant MeSH terms:
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Skin Neoplasms
Lymphedema
Lymphatic Diseases
Neoplasms by Site
Neoplasms
Skin Diseases