ID

27167

Description

Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated Pain; ODM derived from: https://clinicaltrials.gov/show/NCT01028352

Link

https://clinicaltrials.gov/show/NCT01028352

Keywords

Versions (1)
  1. 11/2/17 11/2/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 2, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01028352

English

Eligibility Breast Cancer NCT01028352

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female;
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
histologically proven stage 0-iii invasive carcinoma of the breast that is er and/or pr positive by immunohistochemical staining, who are receiving a standard dose of aromatase inhibitor (ai) therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily). women with oligometastatic disease may be included at the discretion of the principal investigator. surgical resection, chemotherapy, and radiation therapy must have been completed at the time of study enrollment, with the exception of trastuzumab;
Description

Invasive carcinoma of breast TNM Breast tumor staging | Invasive carcinoma of breast Estrogen receptor positive Immunohistochemistry | Invasive carcinoma of breast Progesterone receptor positive Immunohistochemistry | Aromatase Inhibitors Dosage Standard | Letrozole U/day | Exemestane U/day | Anastrozole U/day | Other Coding | Excision Completed | Chemotherapy Completed | Therapeutic radiology procedure Completed | Exception trastuzumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0279754
UMLS CUI [2,3]
C0021044
UMLS CUI [3,1]
C0853879
UMLS CUI [3,2]
C0279759
UMLS CUI [3,3]
C0021044
UMLS CUI [4,1]
C0593802
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C1442989
UMLS CUI [5,1]
C0246421
UMLS CUI [5,2]
C0456683
UMLS CUI [6,1]
C0851344
UMLS CUI [6,2]
C0456683
UMLS CUI [7,1]
C0290883
UMLS CUI [7,2]
C0456683
UMLS CUI [8]
C3846158
UMLS CUI [9,1]
C0728940
UMLS CUI [9,2]
C0205197
UMLS CUI [10,1]
C0392920
UMLS CUI [10,2]
C0205197
UMLS CUI [11,1]
C1522449
UMLS CUI [11,2]
C0205197
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0728747
ai therapy has been ongoing for ≥ 2 weeks and treatment is expected to continue;
Description

Aromatase Inhibitors Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C0449238
ai-associated musculoskeletal symptoms, defined as:
Description

Musculoskeletal symptom Associated with Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0231443
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0593802
grade 1 or higher musculoskeletal pain that developed or worsened (6 or 7 on cgics) during ai therapy or
Description

Musculoskeletal Pain Numeric Pain Scale | Musculoskeletal Pain Clinical Global Impression Questionnaire | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0026858
UMLS CUI [1,2]
C1518471
UMLS CUI [2,1]
C0026858
UMLS CUI [2,2]
C3639708
UMLS CUI [3]
C0593802
grade 1 or higher sensory neuropathy that developed or worsened (6 or 7 on cgics) during ai therapy;
Description

Sensory neuropathy CTCAE Grades | Sensory neuropathy Clinical Global Impression Questionnaire | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0151313
UMLS CUI [2,2]
C3639708
UMLS CUI [3]
C0593802
average pain of ≥4 on the 11-point likert scale of question #5 of the brief pain inventory;
Description

Average Severity of Pain Likert scale | Average Severity of Pain Brief Pain Inventory Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C3641836
UMLS CUI [1,2]
C0451267
UMLS CUI [2,1]
C3641836
UMLS CUI [2,2]
C3539024
ecog performance status 0-2;
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
willing and able to sign an informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to duloxetine or any of the inactive ingredients;
Description

Hypersensitivity Duloxetine | Hypersensitivity Duloxetine inactive ingredient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0245561
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0245561
UMLS CUI [2,3]
C1552019
new musculoskeletal pain that is due specifically to fracture or traumatic injury;
Description

Musculoskeletal Pain Due to Fracture | Musculoskeletal Pain Due to Traumatic injury

Data type

boolean

Alias
UMLS CUI [1,1]
C0026858
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0016658
UMLS CUI [2,1]
C0026858
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C3263723
treatment with monoamine oxidase inhibitors (mao-i) within 14 days of enrollment;
Description

Monoamine Oxidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0026457
concurrent treatment with phenothiazines (including thioridazine), propafenone, flecainide, triptans, mao-is, ssris, snris, or tricyclic antidepressants;
Description

Phenothiazines | Thioridazine | Propafenone | Flecainide | Triptans | Monoamine Oxidase Inhibitors | Selective Serotonin Reuptake Inhibitors | SNRIs | Tricyclic Antidepressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0031436
UMLS CUI [2]
C0039943
UMLS CUI [3]
C0033429
UMLS CUI [4]
C0016229
UMLS CUI [5]
C1567966
UMLS CUI [6]
C0026457
UMLS CUI [7]
C0360105
UMLS CUI [8]
C1579361
UMLS CUI [9]
C0003290
currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder;
Description

Psychiatric Diagnosis Primary | Schizophrenia | Psychotic Disorders | Feeling suicidal | Bipolar Disorder | Epilepsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0376338
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0424000
UMLS CUI [5]
C0005586
UMLS CUI [6]
C0014544
chronic liver disease, end stage renal disease, or creatinine clearance < 30 ml/min as defined by the cockroft-gault equation;
Description

Chronic liver disease | Kidney Failure, Chronic | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2]
C0022661
UMLS CUI [3]
C2711451
uncontrolled narrow-angle glaucoma or clinically significant coagulation disorder;
Description

Angle Closure Glaucoma Uncontrolled | Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0017605
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0005779
pregnant or breast feeding;
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of alcohol or other substance abuse or dependence within the year prior to enrollment;
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation.
Description

Medical condition Serious Reason for hospitalization | Medical condition Unstable Reason for hospitalization | Medical condition Serious compromises Study Subject Participation Status | Medical condition Unstable compromises Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1830395
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C1830395
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C2945640
UMLS CUI [3,4]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C2945640
UMLS CUI [4,4]
C2348568
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Similar models

Eligibility Breast Cancer NCT01028352

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female;
boolean
C0079399 (UMLS CUI [1])
Invasive carcinoma of breast TNM Breast tumor staging | Invasive carcinoma of breast Estrogen receptor positive Immunohistochemistry | Invasive carcinoma of breast Progesterone receptor positive Immunohistochemistry | Aromatase Inhibitors Dosage Standard | Letrozole U/day | Exemestane U/day | Anastrozole U/day | Other Coding | Excision Completed | Chemotherapy Completed | Therapeutic radiology procedure Completed | Exception trastuzumab
Item
histologically proven stage 0-iii invasive carcinoma of the breast that is er and/or pr positive by immunohistochemical staining, who are receiving a standard dose of aromatase inhibitor (ai) therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily). women with oligometastatic disease may be included at the discretion of the principal investigator. surgical resection, chemotherapy, and radiation therapy must have been completed at the time of study enrollment, with the exception of trastuzumab;
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
C0853879 (UMLS CUI [3,1])
C0279759 (UMLS CUI [3,2])
C0021044 (UMLS CUI [3,3])
C0593802 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C1442989 (UMLS CUI [4,3])
C0246421 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
C0851344 (UMLS CUI [6,1])
C0456683 (UMLS CUI [6,2])
C0290883 (UMLS CUI [7,1])
C0456683 (UMLS CUI [7,2])
C3846158 (UMLS CUI [8])
C0728940 (UMLS CUI [9,1])
C0205197 (UMLS CUI [9,2])
C0392920 (UMLS CUI [10,1])
C0205197 (UMLS CUI [10,2])
C1522449 (UMLS CUI [11,1])
C0205197 (UMLS CUI [11,2])
C1705847 (UMLS CUI [12,1])
C0728747 (UMLS CUI [12,2])
Aromatase Inhibitors Duration
Item
ai therapy has been ongoing for ≥ 2 weeks and treatment is expected to continue;
boolean
C0593802 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Musculoskeletal symptom Associated with Aromatase Inhibitors
Item
ai-associated musculoskeletal symptoms, defined as:
boolean
C0231443 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0593802 (UMLS CUI [1,3])
Musculoskeletal Pain Numeric Pain Scale | Musculoskeletal Pain Clinical Global Impression Questionnaire | Aromatase Inhibitors
Item
grade 1 or higher musculoskeletal pain that developed or worsened (6 or 7 on cgics) during ai therapy or
boolean
C0026858 (UMLS CUI [1,1])
C1518471 (UMLS CUI [1,2])
C0026858 (UMLS CUI [2,1])
C3639708 (UMLS CUI [2,2])
C0593802 (UMLS CUI [3])
Sensory neuropathy CTCAE Grades | Sensory neuropathy Clinical Global Impression Questionnaire | Aromatase Inhibitors
Item
grade 1 or higher sensory neuropathy that developed or worsened (6 or 7 on cgics) during ai therapy;
boolean
C0151313 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0151313 (UMLS CUI [2,1])
C3639708 (UMLS CUI [2,2])
C0593802 (UMLS CUI [3])
Average Severity of Pain Likert scale | Average Severity of Pain Brief Pain Inventory Questionnaire
Item
average pain of ≥4 on the 11-point likert scale of question #5 of the brief pain inventory;
boolean
C3641836 (UMLS CUI [1,1])
C0451267 (UMLS CUI [1,2])
C3641836 (UMLS CUI [2,1])
C3539024 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status 0-2;
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
willing and able to sign an informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Duloxetine | Hypersensitivity Duloxetine inactive ingredient
Item
known hypersensitivity to duloxetine or any of the inactive ingredients;
boolean
C0020517 (UMLS CUI [1,1])
C0245561 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0245561 (UMLS CUI [2,2])
C1552019 (UMLS CUI [2,3])
Musculoskeletal Pain Due to Fracture | Musculoskeletal Pain Due to Traumatic injury
Item
new musculoskeletal pain that is due specifically to fracture or traumatic injury;
boolean
C0026858 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0016658 (UMLS CUI [1,3])
C0026858 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C3263723 (UMLS CUI [2,3])
Monoamine Oxidase Inhibitors
Item
treatment with monoamine oxidase inhibitors (mao-i) within 14 days of enrollment;
boolean
C0026457 (UMLS CUI [1])
Phenothiazines | Thioridazine | Propafenone | Flecainide | Triptans | Monoamine Oxidase Inhibitors | Selective Serotonin Reuptake Inhibitors | SNRIs | Tricyclic Antidepressive Agents
Item
concurrent treatment with phenothiazines (including thioridazine), propafenone, flecainide, triptans, mao-is, ssris, snris, or tricyclic antidepressants;
boolean
C0031436 (UMLS CUI [1])
C0039943 (UMLS CUI [2])
C0033429 (UMLS CUI [3])
C0016229 (UMLS CUI [4])
C1567966 (UMLS CUI [5])
C0026457 (UMLS CUI [6])
C0360105 (UMLS CUI [7])
C1579361 (UMLS CUI [8])
C0003290 (UMLS CUI [9])
Psychiatric Diagnosis Primary | Schizophrenia | Psychotic Disorders | Feeling suicidal | Bipolar Disorder | Epilepsy
Item
currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder;
boolean
C0376338 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0424000 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
Chronic liver disease | Kidney Failure, Chronic | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
chronic liver disease, end stage renal disease, or creatinine clearance < 30 ml/min as defined by the cockroft-gault equation;
boolean
C0341439 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Angle Closure Glaucoma Uncontrolled | Blood Coagulation Disorders
Item
uncontrolled narrow-angle glaucoma or clinically significant coagulation disorder;
boolean
C0017605 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders | Substance Dependence
Item
history of alcohol or other substance abuse or dependence within the year prior to enrollment;
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Medical condition Serious Reason for hospitalization | Medical condition Unstable Reason for hospitalization | Medical condition Serious compromises Study Subject Participation Status | Medical condition Unstable compromises Study Subject Participation Status
Item
serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1830395 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C1830395 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C2348568 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
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