ID

26828

Description

Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00895414

Link

https://clinicaltrials.gov/show/NCT00895414

Keywords

Versions (1)
  1. 10/25/17 10/25/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 25, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00895414

English

Eligibility Breast Cancer NCT00895414

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
tissue diagnosis of a breast carcinoma
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
the oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen
Description

Doxorubicin | Chemotherapy Regimen

Data type

boolean

Alias
UMLS CUI [1]
C0013089
UMLS CUI [2]
C0392920
have acceptable organ function within 14 days of enrollment defined as:
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
liver function: total bilirubin, ast and alt within normal institutional limits
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
kidney function: estimated creatinine clearance > 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (scr x 72)
Description

Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C2711451
UMLS CUI [3]
C0373595
UMLS CUI [4]
C0079399
at least 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient must have given written informed consent indicating an understanding of the investigational nature of the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
agrees not to consume grapefruit juice while on the study
Description

GRAPEFRUIT JUICE Consumption Abstinence

Data type

boolean

Alias
UMLS CUI [1,1]
C0452456
UMLS CUI [1,2]
C0009830
UMLS CUI [1,3]
C3843422
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known allergy to enalapril
Description

Enalapril allergy

Data type

boolean

Alias
UMLS CUI [1]
C0571946
taking any known p450 cytochrome inducers or inhibitors
Description

Cytochrome P450 3A4 Inducer | Cytochrome P450 3A4 Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C3830625
UMLS CUI [2]
C3830624
taking any herbal supplements while on the study or the week prior to receiving doxorubicin
Description

Herbal supplement

Data type

boolean

Alias
UMLS CUI [1]
C1504473
taking an ace-inhibitor or angiotensin receptor blocker
Description

ACE Inhibitors | Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0521942
pregnant or lactating. enalapril is pregnancy categories c (first trimester) and d (second and third trimesters)
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT00895414

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
tissue diagnosis of a breast carcinoma
boolean
C0678222 (UMLS CUI [1])
Doxorubicin | Chemotherapy Regimen
Item
the oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen
boolean
C0013089 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Organ function
Item
have acceptable organ function within 14 days of enrollment defined as:
boolean
C0678852 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
liver function: total bilirubin, ast and alt within normal institutional limits
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement | Gender
Item
kidney function: estimated creatinine clearance > 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (scr x 72)
boolean
C0232804 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Age
Item
at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
patient must have given written informed consent indicating an understanding of the investigational nature of the study
boolean
C0021430 (UMLS CUI [1])
GRAPEFRUIT JUICE Consumption Abstinence
Item
agrees not to consume grapefruit juice while on the study
boolean
C0452456 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C3843422 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Enalapril allergy
Item
known allergy to enalapril
boolean
C0571946 (UMLS CUI [1])
Cytochrome P450 3A4 Inducer | Cytochrome P450 3A4 Inhibitor
Item
taking any known p450 cytochrome inducers or inhibitors
boolean
C3830625 (UMLS CUI [1])
C3830624 (UMLS CUI [2])
Herbal supplement
Item
taking any herbal supplements while on the study or the week prior to receiving doxorubicin
boolean
C1504473 (UMLS CUI [1])
ACE Inhibitors | Angiotensin II receptor antagonist
Item
taking an ace-inhibitor or angiotensin receptor blocker
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating. enalapril is pregnancy categories c (first trimester) and d (second and third trimesters)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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