ID

26589

Beskrivning

Liposuction for Arm Lymphedema Following Breast Cancer Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00816985

Länk

https://clinicaltrials.gov/show/NCT00816985

Nyckelord

Versioner (1)
  1. 2017-10-20 2017-10-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 oktober 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00816985

Engelsk

Eligibility Breast Cancer NCT00816985

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C0024236
UMLS CUI [3,2]
C1306673
UMLS CUI [4,1]
C1140618
UMLS CUI [4,2]
C0242485
UMLS CUI [5,1]
C1140618
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C3714763
UMLS CUI [5,4]
C1705242
UMLS CUI [5,5]
C1265611
UMLS CUI [6,1]
C0024236
UMLS CUI [6,2]
C2945599
UMLS CUI [7,1]
C0024236
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0009450
UMLS CUI [8,2]
C0311392
UMLS CUI [8,3]
C0332197
UMLS CUI [9,1]
C0087111
UMLS CUI [9,2]
C0024236
UMLS CUI [10,1]
C0277556
UMLS CUI [10,2]
C0332296
UMLS CUI [11,1]
C0302148
UMLS CUI [11,2]
C0332197
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.
Beskrivning

Manual lymphatic drainage | Compression sleeves | Operative Surgical Procedures Lymphedema Ineligible

Datatyp

boolean

Alias
UMLS CUI [1]
C0556834
UMLS CUI [2]
C0183617
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0024236
UMLS CUI [3,3]
C1512714
eastern cooperative oncology group (ecog) performance status ≤2 (karnofsky ≥60%.
Beskrivning

ECOG performance status | Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
life expectancy of greater than one year
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
patients must have normal organ and marrow function as defined below:
Beskrivning

Organ function | Bone Marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
1. leukocytes ≥3,000/microl
Beskrivning

White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
2. absolute neutrophil count ≥1,500/microl
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
3. platelets ≥100,000/microl
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
4. total bilirubin within normal institutional limits
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
5. aspartic transaminase(ast)/alanine transaminase(alt) ≤2.5 x institutional upper limit of normal
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
6. creatinine within normal institutional limits - or - creatinine clearance ≥60 ml/min/1.73 m² for patients with creatinine levels above institutional normal.
Beskrivning

Creatinine measurement, serum | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
able to tolerate general anesthesia and have no recent cardiac history such as myocardial infarction, congestive heart failure, atrial fibrillation, or angina
Beskrivning

General Anesthesia Receive Ability | Heart Diseases Absent | Myocardial Infarction Absent | Congestive heart failure Absent | Atrial Fibrillation Absent | Angina Pectoris Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002915
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0027051
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0004238
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0002962
UMLS CUI [6,2]
C0332197
ability to understand and the willingness to sign a written informed consent document
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
Beskrivning

Chemotherapy | Therapeutic radiology procedure | Nitrosoureas | Mitomycin | Adverse event Due to Pharmaceutical Preparations | Patient recovered Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0028210
UMLS CUI [4]
C0002475
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0013227
UMLS CUI [6,1]
C1115804
UMLS CUI [6,2]
C0332268
patients may not be receiving any other investigational agents.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
patients with known metastases should be excluded from this clinical trial because of their poor prognosis.
Beskrivning

Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
history of allergic reactions to compression sleeves, lymphedema bandages, general anesthetics, and all antibiotics
Beskrivning

Allergic Reaction Compression sleeves | Allergic Reaction Lymphedema Bandage | Allergic Reaction General anesthetics | Allergic Reaction Antibiotics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0183617
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0024236
UMLS CUI [2,3]
C0004726
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0017302
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0003232
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
Beskrivning

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0439801
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.
Beskrivning

Pregnancy | General Anesthesia Risk Increased Miscarriage | Operative Surgical Procedures Risk Increased Miscarriage | Increased weight Causing Exacerbation Lymphedema | Interpretation Endpoints Difficult

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0002915
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0205217
UMLS CUI [2,4]
C0000786
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0035647
UMLS CUI [3,3]
C0205217
UMLS CUI [3,4]
C0000786
UMLS CUI [4,1]
C0043094
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C4086268
UMLS CUI [4,4]
C0024236
UMLS CUI [5,1]
C0459471
UMLS CUI [5,2]
C2349179
UMLS CUI [5,3]
C0332218
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.
Beskrivning

Immunologic Deficiency Syndromes | Operative Surgical Procedures Risk Increased Communicable Disease Lethal | Surgical Team High risk Needlestick Injuries

Datatyp

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0205217
UMLS CUI [2,4]
C0009450
UMLS CUI [2,5]
C3151529
UMLS CUI [3,1]
C0520261
UMLS CUI [3,2]
C0332167
UMLS CUI [3,3]
C0085178
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Similar models

Eligibility Breast Cancer NCT00816985

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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