Lymphedema is a common complication of breast cancer treatment, affecting approximately a quarter of patients. Those affected can have an uncomfortable, unsightly and sometimes functionally impaired limb prone to episodes of superficial infection. The aetiology and pathophysiology of lymphedema in patients with breast cancer appear to be multifactorial and are still not fully understood.Although conservative treatment techniques can be very successful in controlling symptoms, they do not afford a cure. In this situation of unmet medical need, it is essential to find a new therapeutic solution to treat lymphedema. The approach of the LYMPHARN project is based on dual mRNA strategy delivered by FlashRNA® vector targeting both lymphatic endothelium and surrounding adipose tissue function.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
At day 0, the injection of APERNAVEC vector will be performed in intradermic tissue of the limb affected by lymphedema. Patient will be follow-up for 6 months
CHU de Toulouse
Toulouse, France
Safety profile of APERNAVEC vector injection during the month following the injection
To determine the safety profile with the number, the type and the severity of adverse events) occurring
Time frame: Day 1, Day 2, Day 5, Day 10 and 1 month after injection
Safety profile of APERNAVEC vector injection during 6 months following the injection
Number, type and severity of adverse events occurring between M1 and M3 and between M3 and M6.
Time frame: 1 month, 3 months and 6 months after injection
Feasibility of the procedures
Feasibility will be assessed through the number of patients for whom the injection is actually performed
Time frame: Day 0 (injection visit)
local and systemic inflammatory reaction following injections
Local and systemic inflammation and immune response following injection is a composite measure derived of 5 validated components: fever monitoring, change in the temperature of the treated limb (assessed with a thermal camera), levels of CRP, Fibrinogen, leukocyte ratios, lymphocyte subpopulations, level of Immunoglobulins panel, photographies ( to assess changes in the appearance of the treated limb) and volumetric variation of the affected limb. All of this components are essential and will be aggregated to arrive at one reported value : local and systemic inflammatory reaction following injections
Time frame: Day 0 (post injection), Day 1, Day 2, Day 10, 1 month, 3 months and 6 months after injection
Efficacy of injections
Efficacy will be explored through a composite measure derived from volumetric reduction of the affected limb, change in thickness and stiffness of the cutaneous and subcutaneous tissue of the fore-arm and arm assessed by ultrasound, analysis of modification in the lymphedema capillary network assessed by lymphofluoroscopy, by lymphoscintigraphy, by lymphoMRI, and change in quality of life assessed by the Lymphcol Arm and the SF36 questionnaires. All of this components are essential and will be aggregated to arrive at one reported value : efficacy of injections
Time frame: Day 1, Day 2, Day 10, 1 month, 3 months and 6 months after injection
Pharmacokinetic of the APERNAVEC vector in the blood
Pharmacokinetic of the APERNAVEC vector will be studied through dosage of the vector (p24 protein) in blood by ELISA
Time frame: Day 0, 4 hours post injection, 24h (Day 1), 48h (Day 2), Day 10 and1 month after injection
plasma biobanking
Constitute a plasma biobanking with blood samples
Time frame: Day 0, Day 10 and 1 month after injection
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