Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT00064857
Eligibility Criteria:
Inclusion criteria:
* Unilateral (ipsilateral to breast cancer resection side) lymphedema of the upper extremity.
* Extravascular water ration of \> 1.07/1 between affected vs. normal arm using multiple frequency bioelectric impedence
* Patient is \> 2months from last surgical or radiation treatment to the affected axilla
* Renal and hepatic function:
Creatinine clearance \> 50ml/min, total bili \<2 mg/dl, transaminases \<1.5 x ULN
* Patient not pregnant or breastfeeding. Use of barrier contraception if sexually active.
* ECOG performance of 0-2
* Patient not allergic to pycnogenol
Exclusion criteria:
* Patients treated with their first course of chemotherapy or radiation
* Chemotherapy or radiation to axillary lymph node will exclude patients for 8 weeks following treatment
* Patients with more than one episode of arm cellulitis, venous clot, or woody fibrosis of the affected arm. Antibiotics used to treat cellulitis must be completed at least 4 weeks prior to initial screening
* Patients with a defibrillator Midazolam study only: Patients requiring or benefiting from supplemental oxygen, patients allergic to cherries
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00064857
Study Brief:
Protocol Section:
NCT00064857