ID

34575

Beskrivning

Diindolylmethane in Treating Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01391689

Länk

https://clinicaltrials.gov/show/NCT01391689

Nyckelord

  1. 2019-01-19 2019-01-19 -
Rättsinnehavare

see on clinicaltrials.gov

Uppladdad den

19 januari 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Stage IA Breast Cancer NCT01391689

Eligibility Stage IA Breast Cancer NCT01391689

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
prescribed tam as adjuvant therapy for early stage (0, i, ii, iiia) breast cancer or as chemoprevention in women at high risk for breast cancer
Beskrivning

ID.1

Datatyp

boolean

new or planned prescription of tam therapy; ineligible for randomization until on tam for > 3 months with the expectation to continue use for > 18 months
Beskrivning

ID.2

Datatyp

boolean

mammogram with breast imaging reporting and data system (birads) score of >= 2; (equivalent to the following and similar breast density descriptive terms found in mammogram reports: 2 = scattered fibroglandular elements/densities; 3 = heterogeneously dense tissue; 4 = extremely dense tissue)
Beskrivning

ID.3

Datatyp

boolean

no use of soy-based dietary supplements or willingness to discontinue use, complete a 4-week wash-out period, prior to randomization, and refrain from use during trial period
Beskrivning

ID.4

Datatyp

boolean

if pre-menopausal, non-pregnant (confirmed with urinary pregnancy test); practicing birth control or s/p oophorectomy
Beskrivning

ID.5

Datatyp

boolean

able to complete study run-in activities, including taking study-provided placebo pill twice daily (am & pm) and recording pill intake and any symptoms experienced on a study calendar, with a compliance rate of at least 80%
Beskrivning

ID.6

Datatyp

boolean

normal blood chemistry test that includes sodium and specific kidney and liver function tests (creatinine, alanine amino transferase-alt, aspartate amino transferase-ast) within 30 days of study enrollment; (informed consent form signed)
Beskrivning

ID.7

Datatyp

boolean

no history of hyponatremia
Beskrivning

ID.8

Datatyp

boolean

Similar models

Eligibility Stage IA Breast Cancer NCT01391689

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
prescribed tam as adjuvant therapy for early stage (0, i, ii, iiia) breast cancer or as chemoprevention in women at high risk for breast cancer
boolean
ID.2
Item
new or planned prescription of tam therapy; ineligible for randomization until on tam for > 3 months with the expectation to continue use for > 18 months
boolean
ID.3
Item
mammogram with breast imaging reporting and data system (birads) score of >= 2; (equivalent to the following and similar breast density descriptive terms found in mammogram reports: 2 = scattered fibroglandular elements/densities; 3 = heterogeneously dense tissue; 4 = extremely dense tissue)
boolean
ID.4
Item
no use of soy-based dietary supplements or willingness to discontinue use, complete a 4-week wash-out period, prior to randomization, and refrain from use during trial period
boolean
ID.5
Item
if pre-menopausal, non-pregnant (confirmed with urinary pregnancy test); practicing birth control or s/p oophorectomy
boolean
ID.6
Item
able to complete study run-in activities, including taking study-provided placebo pill twice daily (am & pm) and recording pill intake and any symptoms experienced on a study calendar, with a compliance rate of at least 80%
boolean
ID.7
Item
normal blood chemistry test that includes sodium and specific kidney and liver function tests (creatinine, alanine amino transferase-alt, aspartate amino transferase-ast) within 30 days of study enrollment; (informed consent form signed)
boolean
ID.8
Item
no history of hyponatremia
boolean

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