Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01112189
Study type Interventional
Source Hospital Universitario Dr. Jose E. Gonzalez
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2009
Completion date September 2010

See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A