Understanding lymphatic dysfunction in lymphedema

Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema

This study is trying to understand the differences in lymphatic problems between inherited and cancer-related lymphedema to find new ways to help patients feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University Hospital, Toulouse (Academic / other)
• Locations: 1 site (Toulouse)
• Trial ID: NCT05629026 on ClinicalTrials.gov

What this trial studies

This study investigates the molecular and histological differences between primary and secondary lymphedema, conditions characterized by impaired lymphatic function and swelling. It aims to analyze gene expression in patients who have developed lymphedema, either inherited or as a result of cancer treatment. By utilizing micro-biopsies, the study seeks to uncover potential therapeutic strategies to restore lymphatic function. The research is conducted at the University Hospital in Toulouse, focusing on patients with specific eligibility criteria related to their lymphedema condition.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 who have developed primary or secondary lymphedema after breast cancer treatment.

Not a fit: Patients with active infections, venous insufficiency, or a history of chronic inflammatory diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new therapeutic strategies for managing lymphedema, improving patient quality of life.

How similar studies have performed: While there is limited research directly comparing primary and secondary lymphedema at the molecular level, the study's approach is novel and could provide valuable insights.

Eligibility criteria

Inclusion Criteria:

1. Patients in who developed primary lymphedema or secondary lymphedema after breast cancer treatment.
2. Male and female over the age of 18 and under 75.
3. Patient affiliated to a social security scheme in France.
4. Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.
5. Patients with no recidive \> 3 years after cancer surgery.
6. Patients with Body Mass Index \<35.
7. Patient enrolled in a care pathway for the management of their lymphedema (medical and educational care).
8. Patients wearing a compression orthosis on the limb with lymphedema.

Exclusion Criteria:

1. Patients with strong suspicion or with active bacterial or fungal infection.
2. Patient with venous insufficiency associated with lymphedema.
3. Patient with a history of deep venous thrombosis on the limb with lymphedema.
4. History of chronic inflammatory disease.
5. Active neoplasia during parallel management.
6. Patient already included in another therapeutic trial.
7. Pregnant or breastfeeding woman.
8. Metastatic cancer.
9. Bilateral breast cancer.
10. Obliterative arterial disease.
11. Multiple erysipelas.
12. Active smoking (delayed healing).
13. Medicines that may promote delayed healing (Corticosteroid therapy, immunosuppressants).
14. Medication that thins the blood (aspirin and antiplatelet agent, anti-coagulant).
15. Betadine allergy.
16. Patient under guardianship or trusteeship, persons placed under the protection of justice

Where this trial is running

Toulouse

• Toulouse Hospital — Toulouse, France (Recruiting)

Study contacts

• Principal investigator: Julie Malloizel-Delaunay, MD — University Hospital, Toulouse
• Study coordinator: Julie MALLOIZEL-DELAUNAY, MD

Conditions Lymphedema