Can an mRNA injection rebuild lymphatic flow and ease arm swelling?
NCT ID NCT07793656
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This trial tests an mRNA therapy called APERNAVEC in women with arm lymphedema that developed after breast cancer surgery. The treatment is injected into the skin of the affected limb, aiming to restore lymphatic flow and reduce swelling. Researchers will check how safe the injection is over six months and whether the procedure is feasible. The study includes women with moderate stage 2 lymphedema who have had the condition for at least six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- APERNAVEC, an mRNA therapy injected into the skin of the affected limb
- What this could lead to
- If it works, this could offer a new way to treat lymphedema by restoring lymphatic flow, reducing swelling and improving arm function.
- What could go wrong
- This is an early, small trial with only 9 participants, so results may not apply broadly. The injection could cause side effects, and the therapy may not restore lymphatic function as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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), * Lymphedema evolving during at least 6 months, * Patient who adhere to optimized decongestive therapy, including a compression sleeve worn daily, integrated into an educational care pathway for the management of their lymphedema, * Patients information and signed written consent form, * Patients affiliated to a social security system. Exclusion Criteria: * 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, * Bilateral breast cancer, * Upper limb peripheral arterial disease ipsilateral to the lymphedema, * History of recent (\< 3 months) upper limb deep venous thrombosis ipsilateral to the lymphedema, * Previous shoulder or orthopedic surgery on lymphedematous arm * Any abnormality of the opposite arm (arm without lymphedema), * Trophic disorders on the lymphedematous arm, * Last episode of cellulitis less than six months, * Recurrent cellulitis, * Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months or within 5 half-lives of any investigational product Immunosuppressive and anti-inflammatory treatments (topical and anti-inflammatory dermocorticoids and oral corticosteroids) in the 10 days before the injection or within 5 half-lives. * Patient under judicial protection or enable to express consent, * Females who are or plan to be pregnant or breastfeeding during the course of this study, * Women of childbearing potential (WOCBP) who are sexually active and unwilling to use an adequate birth control method (hormonal or physical barrier), * History of cancer other than breast cancer (excepted basalcell carcinoma), * Any acute, chronic, or severe psychiatric condition that may interfere with participation in the study * Unstable, clinically significant neurologic, psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results. * Known allergy to bovine proteins * Vulnerable patients (persons deprived of their liberty by judicial or administrative decision, persons undergoing psychiatric treatment, persons admitted to a health or social establishment for purposes other than research) according to article L1121-6 of the Public Health Code.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Toulouse
Toulouse, 31059, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could simple exercises restore pelvic health after cervical cancer?
- Beyond swelling: could lymphedema be a Whole-Body biological disorder?
- Could targeted exercises boost recovery for breast Cancer-Related lymphedema?
- New wearable device aims to ease lymphedema swelling
- Could a gentle suction device ease lymphedema?