Gender | Operative Surgical Procedures Breast Carcinoma | Lymphedema Stage | Arm Measurement | Arm Affected Point Different Quantity | Lymphedema Mild | Lymphedema Severe | Communicable Disease Signs Absent | Therapeutic procedure Lymphedema | Recurrent disease Free of | Blood Clot Absent
Item
patient selection involves identifying women who have undergone breast cancer surgery in the past and who demonstrate lymphedema (stage 2 or 3) based on arm measurement at a minimum of 4 different points along the affected arm. those women with mild to severe lymphedema with no signs of active infection are candidates for the procedure. history of previous non-surgical treatment for lymphedema will not preclude entry into this trial. all patients must be free of active disease recurrence at study entry. if the lymphedema is of recent onset, then the womans medical oncologist or primary care physician must rule out an underlying cancer recurrence or blood clot.
boolean
C0079399 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0024236 (UMLS CUI [3,1])
C1306673 (UMLS CUI [3,2])
C1140618 (UMLS CUI [4,1])
C0242485 (UMLS CUI [4,2])
C1140618 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C3714763 (UMLS CUI [5,3])
C1705242 (UMLS CUI [5,4])
C1265611 (UMLS CUI [5,5])
C0024236 (UMLS CUI [6,1])
C2945599 (UMLS CUI [6,2])
C0024236 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0009450 (UMLS CUI [8,1])
C0311392 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
C0087111 (UMLS CUI [9,1])
C0024236 (UMLS CUI [9,2])
C0277556 (UMLS CUI [10,1])
C0332296 (UMLS CUI [10,2])
C0302148 (UMLS CUI [11,1])
C0332197 (UMLS CUI [11,2])
Manual lymphatic drainage | Compression sleeves | Operative Surgical Procedures Lymphedema Ineligible
Item
prior therapy including manuel lymph drainage (mld) or similar massage method, use of compression sleeves, and pneumatic pumps is allowable and may be on-going at study entry. prior surgical procedures to treat lymphedema such a joining the lymph channels to the blood vessels at any prior time are not eligible for this study.
boolean
C0556834 (UMLS CUI [1])
C0183617 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C0024236 (UMLS CUI [3,2])
C1512714 (UMLS CUI [3,3])
ECOG performance status | Karnofsky Performance Status
Item
eastern cooperative oncology group (ecog) performance status ≤2 (karnofsky ≥60%.
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Life Expectancy
Item
life expectancy of greater than one year
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
patients must have normal organ and marrow function as defined below:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
White Blood Cell Count procedure
Item
1. leukocytes ≥3,000/microl
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
2. absolute neutrophil count ≥1,500/microl
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
3. platelets ≥100,000/microl
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
4. total bilirubin within normal institutional limits
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
5. aspartic transaminase(ast)/alanine transaminase(alt) ≤2.5 x institutional upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum | Creatinine clearance measurement
Item
6. creatinine within normal institutional limits - or - creatinine clearance ≥60 ml/min/1.73 m² for patients with creatinine levels above institutional normal.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
General Anesthesia Receive Ability | Heart Diseases Absent | Myocardial Infarction Absent | Congestive heart failure Absent | Atrial Fibrillation Absent | Angina Pectoris Absent
Item
able to tolerate general anesthesia and have no recent cardiac history such as myocardial infarction, congestive heart failure, atrial fibrillation, or angina
boolean
C0002915 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0004238 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0002962 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Nitrosoureas | Mitomycin | Adverse event Due to Pharmaceutical Preparations | Patient recovered Lacking
Item
patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0877248 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C1115804 (UMLS CUI [6,1])
C0332268 (UMLS CUI [6,2])
Investigational New Drugs
Item
patients may not be receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Neoplasm Metastasis
Item
patients with known metastases should be excluded from this clinical trial because of their poor prognosis.
boolean
C0027627 (UMLS CUI [1])
Allergic Reaction Compression sleeves | Allergic Reaction Lymphedema Bandage | Allergic Reaction General anesthetics | Allergic Reaction Antibiotics
Item
history of allergic reactions to compression sleeves, lymphedema bandages, general anesthetics, and all antibiotics
boolean
C1527304 (UMLS CUI [1,1])
C0183617 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0024236 (UMLS CUI [2,2])
C0004726 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0017302 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0003232 (UMLS CUI [4,2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Pregnancy | General Anesthesia Risk Increased Miscarriage | Operative Surgical Procedures Risk Increased Miscarriage | Increased weight Causing Exacerbation Lymphedema | Interpretation Endpoints Difficult
Item
pregnant women are excluded from this study because: general anesthesia and/or invasive surgical procedures may increase the risk of miscarriage. secondly, increased weight during pregnancy may exacerbate lymphedema and thereby make interpretation of the study endpoints difficult.
boolean
C0032961 (UMLS CUI [1])
C0002915 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205217 (UMLS CUI [2,3])
C0000786 (UMLS CUI [2,4])
C0543467 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
C0205217 (UMLS CUI [3,3])
C0000786 (UMLS CUI [3,4])
C0043094 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C4086268 (UMLS CUI [4,3])
C0024236 (UMLS CUI [4,4])
C0459471 (UMLS CUI [5,1])
C2349179 (UMLS CUI [5,2])
C0332218 (UMLS CUI [5,3])
Immunologic Deficiency Syndromes | Operative Surgical Procedures Risk Increased Communicable Disease Lethal | Surgical Team High risk Needlestick Injuries
Item
patients with immune deficiency are at increased risk of lethal infections when treated with invasive surgical procedures. secondly, since this is an elective procedure, the risk to the surgical team of a needle stick would be too high.
boolean
C0021051 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205217 (UMLS CUI [2,3])
C0009450 (UMLS CUI [2,4])
C3151529 (UMLS CUI [2,5])
C0520261 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
C0085178 (UMLS CUI [3,3])