ID

39314

Description

DIetary REstriction as an Adjunct to Neoadjuvant ChemoTherapy for HER2 Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02126449

Link

https://clinicaltrials.gov/show/NCT02126449

Keywords

Versions (1)
  1. 12/18/19 12/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Fasting Mimicking Diet NCT02126449

English

Eligibility Fasting Mimicking Diet NCT02126449

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients with stage ii or iii (ct1cn+ or ≥t2 any cn, cm0) breast cancer receiving neoadjuvant ac-t
Description

Gender | Breast Carcinoma TNM Breast tumor staging | AC-T Regimen Neoadjuvant

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0474926
UMLS CUI [3,1]
C1879500
UMLS CUI [3,2]
C0600558
measurable disease (breast and/or lymph nodes)
Description

Measurable Disease | Breast | Lymph nodes

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0006141
UMLS CUI [3]
C0024204
her2 negative core biopsy age ≥18 years
Description

HER2 Negative Core needle biopsy | Age

Data type

boolean

Alias
UMLS CUI [1,1]
C2348908
UMLS CUI [1,2]
C1318309
UMLS CUI [2]
C0001779
who performance status 0-2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
adequate bone marrow function : white blood cells (wbcs) ≥3.0 x 109/l, neutrophils
Description

Bone Marrow function | White Blood Cell Count procedure | Neutrophil count

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0200633
≥1.5 x 109/l, platelets ≥100 x 109/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
adequate liver function: bilirubin ≤1.5 x upper limit of normal (unl) range, alat and/or asat ≤2.5 x unl, alkaline phosphatase ≤5 x unl
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201850
adequate renal function: the calculated creatinine clearance should be ≥50 ml/min
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C2711451
patients must be accessible for treatment and follow-up
Description

Patient Available Therapeutic procedure | Patient Available Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C3274571
written informed consent according to the local ethics committee requirements
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willing to fill in quality of life questionnaires
Description

Quality of life Questionnaire Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0034380
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0205197
able to read and write in dutch
Description

Able to read Dutch Language | Able to write Dutch Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376241
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376241
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of breast cancer (invasive or non-invasive)
Description

Medical History Invasive carcinoma of breast | Medical History Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0853879
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0678222
previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
Description

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
Description

Disease Serious | Myocardial Infarction | Sign or Symptom Heart failure | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C3540840
UMLS CUI [3,2]
C0018801
UMLS CUI [4]
C0003811
diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
body mass index (bmi) < 19 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
pregnancy or lactating
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
significant food allergies which would make the subject unable to consume the food provided (ex: nuts or soy)
Description

Food Allergy

Data type

boolean

Alias
UMLS CUI [1]
C0016470
any metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods.
Description

Metabolic Diseases Affecting Gluconeogenesis | Metabolic Diseases Affecting Adaptation Fasting

Data type

boolean

Alias
UMLS CUI [1,1]
C0025517
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0017715
UMLS CUI [2,1]
C0025517
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0392673
UMLS CUI [2,4]
C0015663
medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Description

Medical condition Preventing Completion of clinical trial | Mental condition Preventing Completion of clinical trial | Medical condition Preventing Informed Consent | Mental condition Preventing Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0021430
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Similar models

Eligibility Fasting Mimicking Diet NCT02126449

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma TNM Breast tumor staging | AC-T Regimen Neoadjuvant
Item
female patients with stage ii or iii (ct1cn+ or ≥t2 any cn, cm0) breast cancer receiving neoadjuvant ac-t
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
C1879500 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
Measurable Disease | Breast | Lymph nodes
Item
measurable disease (breast and/or lymph nodes)
boolean
C1513041 (UMLS CUI [1])
C0006141 (UMLS CUI [2])
C0024204 (UMLS CUI [3])
HER2 Negative Core needle biopsy | Age
Item
her2 negative core biopsy age ≥18 years
boolean
C2348908 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Bone Marrow function | White Blood Cell Count procedure | Neutrophil count
Item
adequate bone marrow function : white blood cells (wbcs) ≥3.0 x 109/l, neutrophils
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
Platelet Count measurement
Item
≥1.5 x 109/l, platelets ≥100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement
Item
adequate liver function: bilirubin ≤1.5 x upper limit of normal (unl) range, alat and/or asat ≤2.5 x unl, alkaline phosphatase ≤5 x unl
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
adequate renal function: the calculated creatinine clearance should be ≥50 ml/min
boolean
C0232804 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Patient Available Therapeutic procedure | Patient Available Follow-up
Item
patients must be accessible for treatment and follow-up
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Informed Consent
Item
written informed consent according to the local ethics committee requirements
boolean
C0021430 (UMLS CUI [1])
Quality of life Questionnaire Completion
Item
willing to fill in quality of life questionnaires
boolean
C0034380 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Able to read Dutch Language | Able to write Dutch Language
Item
able to read and write in dutch
boolean
C0586740 (UMLS CUI [1,1])
C0376241 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376241 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical History Invasive carcinoma of breast | Medical History Breast Carcinoma
Item
history of breast cancer (invasive or non-invasive)
boolean
C0262926 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Disease Serious | Myocardial Infarction | Sign or Symptom Heart failure | Cardiac Arrhythmia
Item
serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C3540840 (UMLS CUI [3,1])
C0018801 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) < 19 kg/m2
boolean
C1305855 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Food Allergy
Item
significant food allergies which would make the subject unable to consume the food provided (ex: nuts or soy)
boolean
C0016470 (UMLS CUI [1])
Metabolic Diseases Affecting Gluconeogenesis | Metabolic Diseases Affecting Adaptation Fasting
Item
any metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods.
boolean
C0025517 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0017715 (UMLS CUI [1,3])
C0025517 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0392673 (UMLS CUI [2,3])
C0015663 (UMLS CUI [2,4])
Medical condition Preventing Completion of clinical trial | Mental condition Preventing Completion of clinical trial | Medical condition Preventing Informed Consent | Mental condition Preventing Informed Consent
Item
medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
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