A Phase 3 interventional study of Prophylactic lymphaticonvenous anastomosis in Lymphedema of Limb and Malignant Skin Neoplasm, sponsored by Alberta Health Services, Calgary. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-26.
Sponsored by Alberta Health Services, Calgary · Phase 3, Interventional, and Prevention
Among 28 studies in Skin Neoplasms with a site in Canada — 4 open to participants now, 12 under way, 4 of them phase 3. Skin Neoplasms · Canada.
Among the 28 studies in Skin Neoplasms with a site in Canada, this one is the 22nd largest by planned enrollment of the 27 interventional ones that give a count, is one of 3 that started in 2022, is one of 11 in phase 3, reaches primary completion later than 0 of the 11 other live ones, and was the 19th registered.
604 studies on the registry are indexed under Skin Neoplasms; 126 are open to participants now.
Browse Skin Neoplasms studies →4 of the 28 studies in Skin Neoplasms with a site in Canada are open now. Recruiting first, the newest first:
Ankyra Therapeutics, Inc · Sites in Canada, United States
Iovance Biotherapeutics, Inc. · Sites in Canada, United States, Australia and 13 more countries
British Columbia Cancer Agency · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 104 Skin Neoplasms studies recruiting now, 84 (81%) set no upper age limit and 9 (9%) stop at 75 or younger; 15 take children under 18; 25 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
28 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 8 · Phase 3 12 · Phase 4 1
First in 2004; this study’s year is marked. 3 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 55 across 408 interventional studies indexed under Skin Neoplasms.
Median enrollment 113 across the 27 interventional studies, 300 across the 1 observational. Of the 13 that completed or were terminated, 8 (62%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 28 have an industry lead sponsor. The 10 most frequent:
Alberta Health Services, Calgary is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Alberta Health Services, Calgary has 1 study filed under Skin Neoplasms — fewer than ten, so there is no comparison to draw.
6 of the studies in Skin Neoplasms with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05608291Phase 3Regeneron PharmaceuticalsA Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | 2027-01-15 |
| NCT05323253Alpha Tau Medical LTD.Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma | 2027-04 |
| NCT06171750Ankyra Therapeutics, IncPhase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors | 2027-04 |
| NCT06377111University Health Network, TorontoA Study to Test the Benefit of Vitamin B5 in Patients With Melanoma | 2027-08 |
| NCT04273061British Columbia Cancer AgencyInvestigating the Effects of Atezolizumab in People Whose Tumour DNA or RNA Indicates Possible Sensitivity | 2027-10 |
Among the 28 studies in Skin Neoplasms with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Trial Objective: To ascertain the efficacy and impact of prophylactic lymphaticovenous anastomosis for prevention of lymphedema in cutaneous malignancy patients undergoing axillary or groin node dissection as part of cancer treatment. To determine quality of life impact, if any, for patients who receive this treatment. To determine incidence of complications related to nodal dissection are reduced with LVA.
Cancer-related lymphedema (CRLE) is a complex and lifelong implication of cancer treatment. Centres have reported rates of lymphedema following axillary node dissection of 39% (53% following adjuvant radiotherapy), and exceeding 73% following groin node dissection. Lymphedema can have significant quality of life (QoL) implications. Treatment, though helpful, is often burdensome, can require a second party to accomplish, and can be financially draining. Further, lymphedema is a chronic condition that cannot be eliminated once established. Many everyday activities, including self-care, employment, and social participation, as well as self-image, can be negatively impacted.
Given the high prevalence of CRLE, there is an urgency to investigate prophylaxis where possible. Prophylactic lymphaticovenous anastomosis offers this opportunity.
Although lymphaticovenous anastomosis (LVA) has been used for decades to treat existing lymphedema, more recently prophylactic LVA has been explored. Jørgensen et al's 2018 systematic review of 12 studies utilizing prophylactic LVA in cancer patients undergoing axilla or groin lymphadenectomy indicated a 2/3 reduction of CRLE in those treated prophylactically compared to those who did not receive prophylactic treatment.
More recently, Cakmakoglu et al reported on an immediate prophylactic approach whereby the LVA is performed at the time of nodal dissection utilizing fluorescing indocynanine green (ICG) and an operating microscope. This approach aided identification and assessment of the viability of lymphatic vessels in 96% of study cases, thereby augmenting the surgeon's ability to identify and choose the most appropriate vessels. Cakmakoglu's team performed the technique successfully on 22 patients. Of this 22, a single patient developed CRLE during the follow-up period (3 patients died of disease during the follow-up period but showed no sign of CRLE at their demise).
The outlook for LVA in combination with ICG looks promising but, to date, there has not been a Randomized Control Trial (RCT) on this prophylactic LVA technique. Thus, there is a need for robust RCTs utilizing a control group, having clearly defined outcome measures, investing in a significant follow-up period, and integrating blinded assessment in order to objectively demonstrate the impact of prophylactic LVA for patients.
Jørgensen et al's 2018 systematic review of prophylactic LVA case series and studies noted that, while the results were remarkable, the studies collected for the review did not have adequate control for bias and were quite heterogeneous in their cancer type, lymphadenectomy location, lymphedema classification, and assessment measures. QoL measures were not regularly integrated into assessment. Follow-up times varied from 6 months to 69 months with only 3 studies following for a minimum of 24 months.
Trial description:
Study participants will be comprised of patients undergoing lymphadenectomy for cutaneous malignancy. The participants will be block (axilla, groin) randomized using 2 equal groups (control/intervention) of 20 participants each. Participants assigned to the intervention arm will undergo prophylactic LVA as an addendum to their lymph node dissection. This will take place at time of lymphadenectomy surgery. Control participants will not have prophylactic LVA. Both groups will be blinded to treatment.
All participants will have limb volume measurements and photographs taken and the LYMQOL lymphedema-specific quality of life questionnaire administered at baseline (date of surgery) and at 6 month intervals for 24 months. Their recovery and surgical complications will be monitored as per the surgeon's usual followup schedule. At 24 months each participant will undergo a radionuclide lymphoscintigraphy to assess function and health of their lymphatic system. Unblinding will taken place at this juncture except in cases where necessary to unblind earlier to provide exceptional care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention participants will undergo prophylactic lymphaticovenous anastomosis as an addendum to axillary or ilioinguinal lymphadenectomy for treatment of cutaneous malignancy.
Procedure: Prophylactic lymphaticonvenous anastomosis
Control participants will undergo axillary or ilioinguinal lymphadenectomy without lymphaticovenous anastomosis for treatment of cutaneous malignancy .
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.
Presence or absence of lymphedema at 24 months post axillary or groin lymphadenectomy as assessed by limb volume over time.
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.
Time frame: 24 months
Quality of life impact as measured by LYMQOL PROM
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.
Time frame: 24 months
Incidence of evidence of acute post-operative surgical complications
Diagnosis of complications such as cellulitis, dehiscence, lymphocele, and/or prolonged need for drain over 30days
Time frame: 24 months
Plan to share: No
Start is estimated for Jan 2022; primary completion for Dec 2025, 47 months later.
How these figures are worked out, and which studies are left out of them.
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Alberta Health Services, Calgary