Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE) (NCT03658967) | Clinical Trial Compass
CompletedPhase 2
Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE)
Finland, Sweden39 participantsStarted 2018-06-07
Plain-language summary
This study evaluates the efficacy of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer by comparing the effects of active study treatment Lymfactin® to placebo. The study product will be administered in combination with a surgical lymph node transfer operation. In addition, the safety and tolerability of the Lymfactin® treatment will be evaluated.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Female or male patients with secondary lymphedema associated with the treatment of breast cancer and
✓. No evidence of recurrent or active breast cancer for at least 2 years after the breast cancer surgery and/or the end of chemotherapy and/or radiotherapy (excluding endocrine treatment).
✓. Patient understands and voluntarily signs the written informed consent prior to any screening procedure.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
✓. Body Mass Index (BMI) between 18 and 32 inclusive.
✓. Positron Emission Tomography-Computed Tomography (PET CT) scan of the chest and the abdomen within 45 days before the study treatment without signs of active breast cancer or any other malignancy.
✓. Adequate hematologic and end-organ function.
✓. Willingness to comply with scheduled visits, laboratory assessments, and other study-related procedures due to the regulatory requirements related to gene based therapies.
Exclusion criteria
✕. Diagnosed for T4 and/or N2b/N3 stage breast cancer at the time of the original diagnosis.
✕. Evidence (clinical, laboratory or imaging) or history of a neoplasm other than breast cancer (except basal cell carcinoma or cervical in situ carcinoma).
✕. Diagnosed for metastatic breast cancer.
What they're measuring
1
Measurement of the volume of the arms
Timeframe: 24 Months
2
Measurement of the lymphatic flow of the affected arm by quantitative lymphoscintigraphy (99Tc-nanocolloid clearance rate with calculation of transport index).
Timeframe: 24 Months
3
Questionnaire according to the Lymphedema Quality of Life Inventory (LQOLI)
✕. Pregnancy, lactation or a positive or indeterminate pregnancy test.
✕. Current treatment with Cyclooxygenase-2 (COX-2) inhibitors should be interrupted from 2 weeks prior until 4 weeks post-treatment.
✕. Previous treatment with, or participation in a trial of a gene therapy product.
✕. Participation in a clinical trial, which has included interventions in the preceding 6 months or will involve future interventions. Participation in a non-interventional clinical trial, or in a non-interventional follow-up of any clinical trial, does not make the patient inappropriate for the entry into this study.
✕. Current treatment with immunosuppressive drugs.