Breast Cancer Clinical Trial
Official title:
Postoperative Lymphedema Treatment in Upper Extremities Following Axillary Lymphadenectomy by Transplanting Autologous Endothelial Progenitor Cells (EPC)
The post-mastectomy lymphedema is a complication of removal of the breast and nodal plexus
that causes accumulation of lymph and subsequent enlargement of the upper limb. It is the
most common complication of all attributable to mastectomy with axillary dissection and
which occurs in one third of patients who undergo radical mastectomy and radiotherapy
post-operation. Currently the treatment of lymphedema of the upper limb is mainly the use of
compression stockings, the use of pneumatic compression pumps and physiotherapy.
Multiple reports indicate that endothelial progenitor cells (EPC) can differentiate into
various cell lines, reproduced and participate in neoangiogenesis. This study was conducted
in the General Surgery Service, of the Hospital Universitario "Dr. José Eleuterio González
"and proposes the EPC obtained autologous transplantation of bone marrow for the treatment
of postoperative lymphedema in upper limb following axillary lymphadenectomy through the
stimulation of lymphatic neoangiogenesis. The investigators studied 20 female patients over
18 years after axillary lymphadenectomy. The objective is to develop an innovative and
definitive treatment for these patients and to analyze the costs and complications that this
treatment may have.
Phase 1:
The procedure will be as follows:
10 patients were recruited in the General Surgery or Oncology meeting the inclusion
criteria. During the study, patients can´t use any other kind of treatment for the
lymphedema.
Visit 1: We explain the procedure by inviting patients to participate after signing informed
consent. There will be a complete medical history, review of inclusion and exclusion
criteria, signing a letter of informed consent, be requested general laboratory tests (blood
count, biochemical profile), tele-ray.
Visit 2: Initiation colony stimulating factor (Filgrastim SC) to 300 micrograms per day for
3 consecutive days.
Visit 3: Conduct a puncture and bone marrow harvesting under local anesthesia of the
posterior iliac crest with Jamshidi needle to aspirate (approximately 50 - 100ml). The
product obtained will be centrifuged in a refrigerated centrifuge at 3500 Sigma EK15 ®
rpm/15 minutes to 8 ° C with HES 6% (pentastarch 6g/100ml) to obtain the mononuclear cell
layer. Once the cells were obtained will be transported to the operating room to manage the
patient by intramuscular injection of 0.5 to 1 ml in 30 to 50 sites of the affected limb
with a depth of about one centimeter, using a needle number 25. The administration will take
place in the operating room under local anesthesia or sedation if necessary.
Visit 4 and subsequent: clinical evaluation will be conducted each week, especially data
monitoring of infection in the puncture sites. At week 12 post-cell infusion, the latest
revision will be made and carried out measurements in both arms to conclude and determine
the outcome of treatment.
Phase 2 (Control group):
Another 10 patients with lymphedema will be included in a 6 week study to compare the most
common treatment of the lymphedema, the compressed sleeves.
Visit 1: A complete medical history will be performed. A compression sleeve will be given to
the patients for their use during the next 2 weeks.
Visit 2 and 3: On week 2 and 3 of the compression sleeve treatment, the patients will be
measured in both upper extremities as well as assess the symptoms or not that patients
present.
Visit 4 and 5: Patients will stop using the compression sleeve treatment for the next 2
weeks measured both upper extremities and interrogate patients about symptoms during this
period.
Visit 6 and 7: The last 2 weeks of the study patients will be asked to restart the
compressed sleeves treatment and measured both upper extremities and interrogate patients
about symptoms presented during this stage of the study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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