mRNA Therapy to Restore Lymphatic Flow in Secondary Lymphedema
ConditionSecondary Lymphedema
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women who developed upper limb lymphedema after surgery for breast cancer hormone receptor positive (HR+) more than 5 years,
Age> 18 years,
Body mass Index (BMI)<40,
Stage 2 Lymphedema, moderate (defined by an increase in volume between 20 and 40% compare to the healthy limb),
Disqualifiers
HER2+ breast cancer triple positive,
Other aggressive breast cancers (including triple negative and inflammatory breast cancer),
Active cancer needing chemo- or radio-therapy,
Metastatic breast cancer,
Trial design
Design model
Single group
Treatments tested in this trial
APERNAVEC
DrugAt 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
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 injectionSecondary outcomes
1
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 injection2
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)3
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 injection4
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 injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: