ID

38124

Beskrivning

Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01802346

Länk

https://clinicaltrials.gov/show/NCT01802346

Nyckelord

Versioner (1)
  1. 2019-09-19 2019-09-19 -
Rättsinnehavare

See clinicaltrials.gov

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19 september 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01802346

Engelsk

Eligibility Breast Cancer NCT01802346

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed breast cancer for which chemotherapy with ac (doxorubicin plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting or metastatic prostate adenocarcinoma for which docetaxel will be administered
Beskrivning

Breast Carcinoma | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | Doxorubicin | Cyclophosphamide | Adenocarcinoma of the prostate metastatic | docetaxel

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [3]
C0085533
UMLS CUI [4]
C0013089
UMLS CUI [5]
C0010583
UMLS CUI [6]
C0862636
UMLS CUI [7]
C0246415
body mass index (bmi) >= 18.5
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
subjects do not need to have measurable or evaluable disease; chemotherapy may be administered in the neoadjuvant, adjuvant, or metastatic setting
Beskrivning

Requirement Absent Measurable Disease | Requirement Absent Evaluable Disease | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | Chemotherapy Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1513041
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1516986
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C3665472
UMLS CUI [4]
C0085533
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0027627
prior therapy:
Beskrivning

Prior Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
breast cancer subjects may not have received prior chemotherapy, with the exception of curative-intent chemotherapy for a separate malignancy more than 3 years ago
Beskrivning

Breast Carcinoma Study Subject | Prior Chemotherapy Absent | Exception Chemotherapy Curative Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0681850
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C1276305
UMLS CUI [3,4]
C1707251
prostate cancer subjects may have received prior treatment with metronomic cyclophosphamide as this is considered anti-angiogenic/immunomodulatory and not cytotoxic
Beskrivning

Prostate carcinoma Study Subject | Prior Therapy | Metronomic Cyclophosphamide | Antiangiogenic therapy | Immunomodulation | Cytotoxic Chemotherapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0681850
UMLS CUI [2]
C1514463
UMLS CUI [3,1]
C1881814
UMLS CUI [3,2]
C0010583
UMLS CUI [4]
C2363719
UMLS CUI [5]
C1963758
UMLS CUI [6,1]
C0677881
UMLS CUI [6,2]
C0332197
prostate cancer subjects may be receiving a 2nd course of docetaxel provided that ** the first course resulted in a psa response (> 30% reduction in prostate specific antigen [psa] and/or improvement in radiographic findings or pain) and the last dose was >= 9 months ago
Beskrivning

Prostate carcinoma Study Subject | Course second Docetaxel | Course First PSA Response | PSA decreased | Improvement Radiography | Improvement Pain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0681850
UMLS CUI [2,1]
C0750729
UMLS CUI [2,2]
C0205436
UMLS CUI [2,3]
C0246415
UMLS CUI [3,1]
C0750729
UMLS CUI [3,2]
C0205435
UMLS CUI [3,3]
C0138741
UMLS CUI [3,4]
C1704632
UMLS CUI [4]
C0178414
UMLS CUI [5,1]
C2986411
UMLS CUI [5,2]
C0034571
UMLS CUI [6,1]
C2986411
UMLS CUI [6,2]
C0030193
prior radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment
Beskrivning

Prior radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279134
eastern cooperative oncology group (ecog) performance status 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
aspartate aminotransferase (ast) and alanine aminotransferase (alt) < 2x upper limit of normal (uln)
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
absolute neutrophil count (anc) > 1500
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets (plts) > 90,000
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period
Beskrivning

Premenopausal state Pregnancy test negative | Premenopausal state Barrier Contraception

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C0232969
UMLS CUI [2,2]
C0004764
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
diabetes mellitus
Beskrivning

Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
peripheral neuropathy >= grade 1
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
prior therapy with inhibitors of igf-1
Beskrivning

Prior Therapy | IGF-1 inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0021665
UMLS CUI [2,2]
C0243077
concurrent use of somatostatin
Beskrivning

Somatostatin

Datatyp

boolean

Alias
UMLS CUI [1]
C0037659
significant food allergies which would make the subject unable to consume the food provided (ex: shellfish, soy or egg allergy)
Beskrivning

Food Allergy | Shellfish allergy | Allergy to soy | Allergy to eggs

Datatyp

boolean

Alias
UMLS CUI [1]
C0016470
UMLS CUI [2]
C0577625
UMLS CUI [3]
C4075590
UMLS CUI [4]
C0559469
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Similar models

Eligibility Breast Cancer NCT01802346

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | Doxorubicin | Cyclophosphamide | Adenocarcinoma of the prostate metastatic | docetaxel
Item
histologically confirmed breast cancer for which chemotherapy with ac (doxorubicin plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting or metastatic prostate adenocarcinoma for which docetaxel will be administered
boolean
C0678222 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3])
C0013089 (UMLS CUI [4])
C0010583 (UMLS CUI [5])
C0862636 (UMLS CUI [6])
C0246415 (UMLS CUI [7])
Body mass index
Item
body mass index (bmi) >= 18.5
boolean
C1305855 (UMLS CUI [1])
Requirement Absent Measurable Disease | Requirement Absent Evaluable Disease | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | Chemotherapy Neoplasm Metastasis
Item
subjects do not need to have measurable or evaluable disease; chemotherapy may be administered in the neoadjuvant, adjuvant, or metastatic setting
boolean
C1514873 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1513041 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1516986 (UMLS CUI [2,3])
C0600558 (UMLS CUI [3,1])
C3665472 (UMLS CUI [3,2])
C0085533 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
Prior Therapy
Item
prior therapy:
boolean
C1514463 (UMLS CUI [1])
Breast Carcinoma Study Subject | Prior Chemotherapy Absent | Exception Chemotherapy Curative Cancer Other
Item
breast cancer subjects may not have received prior chemotherapy, with the exception of curative-intent chemotherapy for a separate malignancy more than 3 years ago
boolean
C0678222 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C1276305 (UMLS CUI [3,3])
C1707251 (UMLS CUI [3,4])
Prostate carcinoma Study Subject | Prior Therapy | Metronomic Cyclophosphamide | Antiangiogenic therapy | Immunomodulation | Cytotoxic Chemotherapy Absent
Item
prostate cancer subjects may have received prior treatment with metronomic cyclophosphamide as this is considered anti-angiogenic/immunomodulatory and not cytotoxic
boolean
C0600139 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2])
C1881814 (UMLS CUI [3,1])
C0010583 (UMLS CUI [3,2])
C2363719 (UMLS CUI [4])
C1963758 (UMLS CUI [5])
C0677881 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Prostate carcinoma Study Subject | Course second Docetaxel | Course First PSA Response | PSA decreased | Improvement Radiography | Improvement Pain
Item
prostate cancer subjects may be receiving a 2nd course of docetaxel provided that ** the first course resulted in a psa response (> 30% reduction in prostate specific antigen [psa] and/or improvement in radiographic findings or pain) and the last dose was >= 9 months ago
boolean
C0600139 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0750729 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0246415 (UMLS CUI [2,3])
C0750729 (UMLS CUI [3,1])
C0205435 (UMLS CUI [3,2])
C0138741 (UMLS CUI [3,3])
C1704632 (UMLS CUI [3,4])
C0178414 (UMLS CUI [4])
C2986411 (UMLS CUI [5,1])
C0034571 (UMLS CUI [5,2])
C2986411 (UMLS CUI [6,1])
C0030193 (UMLS CUI [6,2])
Prior radiation therapy
Item
prior radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment
boolean
C0279134 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
aspartate aminotransferase (ast) and alanine aminotransferase (alt) < 2x upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) > 1500
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets (plts) > 90,000
boolean
C0032181 (UMLS CUI [1])
Premenopausal state Pregnancy test negative | Premenopausal state Barrier Contraception
Item
premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period
boolean
C0232969 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy >= grade 1
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Prior Therapy | IGF-1 inhibitors
Item
prior therapy with inhibitors of igf-1
boolean
C1514463 (UMLS CUI [1])
C0021665 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
Somatostatin
Item
concurrent use of somatostatin
boolean
C0037659 (UMLS CUI [1])
Food Allergy | Shellfish allergy | Allergy to soy | Allergy to eggs
Item
significant food allergies which would make the subject unable to consume the food provided (ex: shellfish, soy or egg allergy)
boolean
C0016470 (UMLS CUI [1])
C0577625 (UMLS CUI [2])
C4075590 (UMLS CUI [3])
C0559469 (UMLS CUI [4])
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