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Lymphatic Reconstruction to Prevent Lymphedema After Skin Cancer Surgery (LYMbR Trial)
Phase 3
Waitlist Available
Led By Claire Temple-Oberle, MD, MSc, FRCSC, MMEd
Research Sponsored by Alberta Health Services, Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult persons (>18 years of age) undergoing axilla or groin lymphadenectomy as part of cutaneous malignancy management.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
LYMbR Trial Summary
This trial is testing whether a prophylactic lymphaticovenous anastomosis (LVA) can reduce the risk of lymphedema by 2/3 in patients undergoing axillary or groin lymphadenectomy.
Who is the study for?
Adults over 18 who are undergoing lymph node removal in the armpit or groin area due to skin cancer can join. It's not for those just getting a sentinel lymph node biopsy, with untreated limb disease, leg vein clots (post-thrombotic syndrome), pregnancy, prior radiation in the area, or pre-existing lymphedema.Check my eligibility
What is being tested?
The trial is testing if doing a special procedure called prophylactic LVA during surgery for skin cancer can prevent swelling of limbs (lymphedema). Participants will be randomly placed into groups and followed up to see if they develop lymphedema and how their quality of life is affected.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally such surgical procedures may include risks like infection at the site of surgery, blood clots, scarring, and possibly changes in sensation around the treated areas.
LYMbR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult having lymph node removal in my armpit or groin for skin cancer treatment.
LYMbR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Presence or absence of lymphedema at 24 months post axillary or groin lymphadenectomy as assessed by limb volume over time.
Quality of life impact as measured by LYMQOL PROM
Secondary outcome measures
Incidence of evidence of acute post-operative surgical complications
LYMbR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prophylactic lymphaticovenous anastomosisExperimental Treatment1 Intervention
Intervention participants will undergo prophylactic lymphaticovenous anastomosis as an addendum to axillary or ilioinguinal lymphadenectomy for treatment of cutaneous malignancy.
Group II: Lymphadenectomy without lymphaticovenous anastomosisActive Control1 Intervention
Control participants will undergo axillary or ilioinguinal lymphadenectomy without lymphaticovenous anastomosis for treatment of cutaneous malignancy .
Find a Location
Who is running the clinical trial?
Alberta Health Services, CalgaryLead Sponsor
13 Previous Clinical Trials
2,561 Total Patients Enrolled
University of CalgaryOTHER
791 Previous Clinical Trials
868,694 Total Patients Enrolled
Tom Baker Cancer CentreOTHER
29 Previous Clinical Trials
8,815 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have swelling in my limbs before surgery.I have had radiation therapy on the area where my cancer's lymph nodes are located.I am only getting a sentinel lymph node biopsy.I am an adult having lymph node removal in my armpit or groin for skin cancer treatment.I have untreated cancer spread to the skin or lymph vessels of my arms or legs.I have post-thrombotic syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Lymphadenectomy without lymphaticovenous anastomosis
- Group 2: Prophylactic lymphaticovenous anastomosis
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the government's opinion on Prophylactic lymphaticonvenous anastomosis?
"This intervention has shown some efficacy in previous trials and has thus been given a safety score of 3."
Answered by AI
Are patients being recruited for this research project at this time?
"The clinical trial in question is not presently recruiting patients, as indicated by the clinicaltrials.gov website. The trial was originally posted on 1/1/2022 and was most recently edited on 11/24/2021. There are currently 241 other trials enrolling participants."
Answered by AI
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