ID

32483

Beskrivning

Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00998738

Länk

https://clinicaltrials.gov/show/NCT00998738

Nyckelord

Versioner (1)
  1. 2018-11-03 2018-11-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 november 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Stage IV Breast Cancer NCT00998738

Engelsk

Eligibility Stage IV Breast Cancer NCT00998738

1 Formulär  
Criteria
Beskrivning

Criteria

scheduled to undergo cancer treatment for metastatic breast cancer (weekly or once every three weeks) with ixabepilone with no prior exposure to ixabepilone and no more than 2 prior chemotherapy regimens for metastatic disease
Beskrivning

Cancer treatment Scheduled Frequency | Secondary malignant neoplasm of female breast | ixabepilone | Prior Chemotherapy Quantity Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205539
UMLS CUI [1,3]
C0439603
UMLS CUI [2]
C0346993
UMLS CUI [3]
C1135132
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0027627
serum calcium =< 1.2 x unl
Beskrivning

Serum calcium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0728876
serum magnesium =< unl
Beskrivning

Serum magnesium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202125
serum creatinine =< 1.5 x unl
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
ability to sign informed consent and understand the nature of a placebo-controlled trial
Beskrivning

Informed Consent | Comprehension Clinical Trial placebo-controlled

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C1706408
ecog performance status (ps) of 0, 1, or 2 (this form is on the mayo clinic cancer research consortium (mccrc) website https:/mccrc.mayo.edu/mccrc/forms/nonprotocolspecificforms/)
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
ability to complete questionnaire(s) by themselves or with assistance - life expectancy >= 4 months
Beskrivning

Questionnaires Completion | Questionnaires Completion Assisted | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C1269765
UMLS CUI [3]
C0023671
presence of a central line placed for administration of calcium and magnesium
Beskrivning

Central line placement Administration Calcium | Central line placement Administration Magnesium

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0919865
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0006675
UMLS CUI [2,1]
C0919865
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0024467
please contact study investigator and/or consult protocol document for specific details on laboratory criteria
Beskrivning

Laboratory criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0243161
exclusion:
Beskrivning

Exclusion

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
pre-existing history of peripheral neuropathy >= grade 2 (nci ctcae active version) due to any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.)
Beskrivning

Peripheral Neuropathy Pre-existing CTCAE Grades | Etiology Chemotherapy | Etiology Diabetes Mellitus | Etiology Alcohol | Etiology Toxin | Etiology Hereditary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0392920
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0011849
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0001962
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0040549
UMLS CUI [6,1]
C0015127
UMLS CUI [6,2]
C0439660
concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, capsaicin cream, etc., or any other treatments specifically for prevention or treatment of neuropathy
Beskrivning

Anticonvulsants | Tricyclic Antidepressive Agents | Drugs used in neuropathic pain | Carbamazepine | Phenytoin | Valproic Acid | gabapentin | lamotrigine | Lidocaine Topical Product | Capsaicin Topical Cream | Treatment Neuropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0003286
UMLS CUI [2]
C0003290
UMLS CUI [3]
C1319667
UMLS CUI [4]
C0006949
UMLS CUI [5]
C0031507
UMLS CUI [6]
C0042291
UMLS CUI [7]
C0060926
UMLS CUI [8]
C0064636
UMLS CUI [9]
C0360097
UMLS CUI [10]
C1251865
UMLS CUI [11,1]
C0087111
UMLS CUI [11,2]
C0442874
other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient
Beskrivning

Other medical condition Study Subject Participation Status At risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
any of the following: pregnant women; nursing women; women of childbearing potential (per physician judgment)
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
diagnosed diabetes requiring insulin or oral hypoglycemic medications -
Beskrivning

Diabetes Mellitus Requirement Insulin | Diabetes Mellitus Requirement Hypoglycemic Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021641
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0020616
receiving digoxin or digitoxin
Beskrivning

Digoxin | Digitoxin

Datatyp

boolean

Alias
UMLS CUI [1]
C0012265
UMLS CUI [2]
C0012258
history of heart block (any degree)
Beskrivning

First degree atrioventricular block | Second degree atrioventricular block | Complete atrioventricular block

Datatyp

boolean

Alias
UMLS CUI [1]
C0085614
UMLS CUI [2]
C0264906
UMLS CUI [3]
C0151517
current treatment for arrhythmias
Beskrivning

Treatment Cardiac Arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003811
concurrent treatment with other neuropathic chemotherapy agents
Beskrivning

Chemotherapeutic Agents Neuropathy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0442874
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Similar models

Eligibility Stage IV Breast Cancer NCT00998738

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Cancer treatment Scheduled Frequency | Secondary malignant neoplasm of female breast | ixabepilone | Prior Chemotherapy Quantity Neoplasm Metastasis
Item
scheduled to undergo cancer treatment for metastatic breast cancer (weekly or once every three weeks) with ixabepilone with no prior exposure to ixabepilone and no more than 2 prior chemotherapy regimens for metastatic disease
boolean
C0920425 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0346993 (UMLS CUI [2])
C1135132 (UMLS CUI [3])
C1514457 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
Serum calcium measurement
Item
serum calcium =< 1.2 x unl
boolean
C0728876 (UMLS CUI [1])
Serum magnesium measurement
Item
serum magnesium =< unl
boolean
C0202125 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine =< 1.5 x unl
boolean
C0201976 (UMLS CUI [1])
Informed Consent | Comprehension Clinical Trial placebo-controlled
Item
ability to sign informed consent and understand the nature of a placebo-controlled trial
boolean
C0021430 (UMLS CUI [1])
C0162340 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1706408 (UMLS CUI [2,3])
ECOG performance status
Item
ecog performance status (ps) of 0, 1, or 2 (this form is on the mayo clinic cancer research consortium (mccrc) website https:/mccrc.mayo.edu/mccrc/forms/nonprotocolspecificforms/)
boolean
C1520224 (UMLS CUI [1])
Questionnaires Completion | Questionnaires Completion Assisted | Life Expectancy
Item
ability to complete questionnaire(s) by themselves or with assistance - life expectancy >= 4 months
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1269765 (UMLS CUI [2,3])
C0023671 (UMLS CUI [3])
Central line placement Administration Calcium | Central line placement Administration Magnesium
Item
presence of a central line placed for administration of calcium and magnesium
boolean
C0919865 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0006675 (UMLS CUI [1,3])
C0919865 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0024467 (UMLS CUI [2,3])
Laboratory criteria
Item
please contact study investigator and/or consult protocol document for specific details on laboratory criteria
boolean
C0022885 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Exclusion
Item
exclusion:
boolean
C0680251 (UMLS CUI [1])
Peripheral Neuropathy Pre-existing CTCAE Grades | Etiology Chemotherapy | Etiology Diabetes Mellitus | Etiology Alcohol | Etiology Toxin | Etiology Hereditary
Item
pre-existing history of peripheral neuropathy >= grade 2 (nci ctcae active version) due to any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.)
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0011849 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0001962 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0040549 (UMLS CUI [5,2])
C0015127 (UMLS CUI [6,1])
C0439660 (UMLS CUI [6,2])
Anticonvulsants | Tricyclic Antidepressive Agents | Drugs used in neuropathic pain | Carbamazepine | Phenytoin | Valproic Acid | gabapentin | lamotrigine | Lidocaine Topical Product | Capsaicin Topical Cream | Treatment Neuropathy
Item
concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, capsaicin cream, etc., or any other treatments specifically for prevention or treatment of neuropathy
boolean
C0003286 (UMLS CUI [1])
C0003290 (UMLS CUI [2])
C1319667 (UMLS CUI [3])
C0006949 (UMLS CUI [4])
C0031507 (UMLS CUI [5])
C0042291 (UMLS CUI [6])
C0060926 (UMLS CUI [7])
C0064636 (UMLS CUI [8])
C0360097 (UMLS CUI [9])
C1251865 (UMLS CUI [10])
C0087111 (UMLS CUI [11,1])
C0442874 (UMLS CUI [11,2])
Other medical condition Study Subject Participation Status At risk
Item
other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Childbearing Potential
Item
any of the following: pregnant women; nursing women; women of childbearing potential (per physician judgment)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Diabetes Mellitus Requirement Insulin | Diabetes Mellitus Requirement Hypoglycemic Agents
Item
diagnosed diabetes requiring insulin or oral hypoglycemic medications -
boolean
C0011849 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0020616 (UMLS CUI [2,3])
Digoxin | Digitoxin
Item
receiving digoxin or digitoxin
boolean
C0012265 (UMLS CUI [1])
C0012258 (UMLS CUI [2])
First degree atrioventricular block | Second degree atrioventricular block | Complete atrioventricular block
Item
history of heart block (any degree)
boolean
C0085614 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
Treatment Cardiac Arrhythmia
Item
current treatment for arrhythmias
boolean
C0087111 (UMLS CUI [1,1])
C0003811 (UMLS CUI [1,2])
Chemotherapeutic Agents Neuropathy
Item
concurrent treatment with other neuropathic chemotherapy agents
boolean
C0003392 (UMLS CUI [1,1])
C0442874 (UMLS CUI [1,2])
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