ID

21826

Description

Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00343863

Lien

https://clinicaltrials.gov/show/NCT00343863

Mots-clés

Versions (1)
  1. 03/05/2017 03/05/2017 -
Téléchargé le

3 mai 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Male Breast Cancer NCT00343863

Anglais

Eligibility Male Breast Cancer NCT00343863

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a histologically confirmed diagnosis of primary breast carcinoma
Description

Carcinoma of Male Breast Primary

Type de données

boolean

Alias
UMLS CUI [1,1]
C0238033
UMLS CUI [1,2]
C0205225
patient must be naive to chemotherapy at the time of enrollment
Description

Chemotherapy naive

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0919936
patients must have prescribed weekly intravenous adriamycin (doxorubicin) and daily oral cyclophosphamide treatment for early breast cancer
Description

Adriamycin Intravenous Weekly | Doxorubicin Intravenous Weekly | Cyclophosphamide Oral Daily | Early-Stage Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085752
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0332174
UMLS CUI [2,1]
C0013089
UMLS CUI [2,2]
C1522726
UMLS CUI [2,3]
C0332174
UMLS CUI [3,1]
C0010583
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0332173
UMLS CUI [4]
C2986665
the patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
patients must have a karnofsky index of greater than or equal to 50%
Description

Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C0206065
known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the investigator
Description

Hepatic impairment Mild | Renal Insufficiency Mild | Cardiovascular impairment Mild | Hepatic impairment Moderate | Renal Insufficiency Moderate | Cardiovascular impairment Moderate

Type de données

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C2945599
UMLS CUI [3,1]
C0848757
UMLS CUI [3,2]
C2945599
UMLS CUI [4,1]
C0948807
UMLS CUI [4,2]
C0205081
UMLS CUI [5,1]
C1565489
UMLS CUI [5,2]
C0205081
UMLS CUI [6,1]
C0848757
UMLS CUI [6,2]
C0205081
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
receipt of investigational drug within 30 days before study entry
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
received any drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent (with the exception of administration of the palonosetron/dexamethasone infusion solution), including the following: 5-ht3 receptor antagonists; dopamine receptor antagonists (metoclopramide); phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine); diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide (diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes); all benzodiazepines; haloperidol, droperidol, tetrahydrocannabinol, or nabilone; any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone) (topical or inhaled preparations are allowed)
Description

Antiemetics | Chemotherapeutic Agents | Palonosetron Infusion solution | Dexamethasone Infusion solution | 5-HT>3< receptor antagonist | Dopamine Antagonists | Metoclopramide | phenothiazine | Prochlorperazine | Thiethylperazine | Perphenazine | Diphenhydramine | Scopolamine | Chlorpheniramine Maleate | trimethobenzamide | Hypersensitivity Taxane | Benzodiazepines | Haloperidol | Droperidol | Tetrahydrocannabinol | nabilone | CORTICOSTEROIDS FOR SYSTEMIC USE | Hydrocortisone | Methylprednisolone | Prednisone | Topical corticosteroids | inhaled steroids

Type de données

boolean

Alias
UMLS CUI [1]
C0003297
UMLS CUI [2]
C0003392
UMLS CUI [3,1]
C0220578
UMLS CUI [3,2]
C1272893
UMLS CUI [4,1]
C0011777
UMLS CUI [4,2]
C1272893
UMLS CUI [5]
C0360055
UMLS CUI [6]
C0242702
UMLS CUI [7]
C0025853
UMLS CUI [8]
C0031434
UMLS CUI [9]
C0033229
UMLS CUI [10]
C0039865
UMLS CUI [11]
C0031184
UMLS CUI [12]
C0012522
UMLS CUI [13]
C0036442
UMLS CUI [14]
C0546857
UMLS CUI [15]
C0077163
UMLS CUI [16,1]
C0020517
UMLS CUI [16,2]
C0215136
UMLS CUI [17]
C0005064
UMLS CUI [18]
C0018546
UMLS CUI [19]
C0013136
UMLS CUI [20]
C0039663
UMLS CUI [21]
C0068333
UMLS CUI [22]
C3653708
UMLS CUI [23]
C0020268
UMLS CUI [24]
C0025815
UMLS CUI [25]
C0032952
UMLS CUI [26]
C0304604
UMLS CUI [27]
C2065041
any vomiting, retching or nci common toxicity criteria version 3.0 grade 2-4 nausea in the 24 hours preceding chemotherapy
Description

Vomiting | Retching | Nausea CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1]
C0042963
UMLS CUI [2]
C0232602
UMLS CUI [3,1]
C0027497
UMLS CUI [3,2]
C1516728
ongoing vomiting from any organic etiology
Description

Vomiting Etiology Organ system

Type de données

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0460002
need to receive systemic corticosteroids, except: a) when defined as part of the chemotherapy regimen as a preventative measure for chemotherapy toxicities; b) topical or inhaled preparations; and/or c) when used as rescue medication during the study
Description

CORTICOSTEROIDS FOR SYSTEMIC USE Patient need for | Chemotherapy | Prophylactic treatment Chemotherapy Toxicity | Topical form corticosteroids | inhaled steroids

Type de données

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0686904
UMLS CUI [2]
C0392920
UMLS CUI [3,1]
C0199176
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C0600688
UMLS CUI [4]
C0304604
UMLS CUI [5]
C2065041
known contraindication to 5-ht3 receptor antagonists (including palonosetron) or dexamethasone
Description

Medical contraindication 5-HT>3< receptor antagonist | Medical contraindication palonosetron | Medical contraindication Dexamethasone

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0360055
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0220578
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0011777
need to receive radiotherapy during the study
Description

Therapeutic radiology procedure Patient need for

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0686904
inability to understand or cooperate with study procedures
Description

Protocol Compliance Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Male Breast Cancer NCT00343863

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Carcinoma of Male Breast Primary
Item
patients must have a histologically confirmed diagnosis of primary breast carcinoma
boolean
C0238033 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Chemotherapy naive
Item
patient must be naive to chemotherapy at the time of enrollment
boolean
C0392920 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Adriamycin Intravenous Weekly | Doxorubicin Intravenous Weekly | Cyclophosphamide Oral Daily | Early-Stage Breast Carcinoma
Item
patients must have prescribed weekly intravenous adriamycin (doxorubicin) and daily oral cyclophosphamide treatment for early breast cancer
boolean
C0085752 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0332174 (UMLS CUI [1,3])
C0013089 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
C0010583 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
C2986665 (UMLS CUI [4])
Informed Consent
Item
the patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
boolean
C0021430 (UMLS CUI [1])
Karnofsky Performance Status
Item
patients must have a karnofsky index of greater than or equal to 50%
boolean
C0206065 (UMLS CUI [1])
Hepatic impairment Mild | Renal Insufficiency Mild | Cardiovascular impairment Mild | Hepatic impairment Moderate | Renal Insufficiency Moderate | Cardiovascular impairment Moderate
Item
known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the investigator
boolean
C0948807 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0848757 (UMLS CUI [3,1])
C2945599 (UMLS CUI [3,2])
C0948807 (UMLS CUI [4,1])
C0205081 (UMLS CUI [4,2])
C1565489 (UMLS CUI [5,1])
C0205081 (UMLS CUI [5,2])
C0848757 (UMLS CUI [6,1])
C0205081 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
receipt of investigational drug within 30 days before study entry
boolean
C0013230 (UMLS CUI [1])
Antiemetics | Chemotherapeutic Agents | Palonosetron Infusion solution | Dexamethasone Infusion solution | 5-HT>3< receptor antagonist | Dopamine Antagonists | Metoclopramide | phenothiazine | Prochlorperazine | Thiethylperazine | Perphenazine | Diphenhydramine | Scopolamine | Chlorpheniramine Maleate | trimethobenzamide | Hypersensitivity Taxane | Benzodiazepines | Haloperidol | Droperidol | Tetrahydrocannabinol | nabilone | CORTICOSTEROIDS FOR SYSTEMIC USE | Hydrocortisone | Methylprednisolone | Prednisone | Topical corticosteroids | inhaled steroids
Item
received any drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent (with the exception of administration of the palonosetron/dexamethasone infusion solution), including the following: 5-ht3 receptor antagonists; dopamine receptor antagonists (metoclopramide); phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine); diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide (diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes); all benzodiazepines; haloperidol, droperidol, tetrahydrocannabinol, or nabilone; any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone) (topical or inhaled preparations are allowed)
boolean
C0003297 (UMLS CUI [1])
C0003392 (UMLS CUI [2])
C0220578 (UMLS CUI [3,1])
C1272893 (UMLS CUI [3,2])
C0011777 (UMLS CUI [4,1])
C1272893 (UMLS CUI [4,2])
C0360055 (UMLS CUI [5])
C0242702 (UMLS CUI [6])
C0025853 (UMLS CUI [7])
C0031434 (UMLS CUI [8])
C0033229 (UMLS CUI [9])
C0039865 (UMLS CUI [10])
C0031184 (UMLS CUI [11])
C0012522 (UMLS CUI [12])
C0036442 (UMLS CUI [13])
C0546857 (UMLS CUI [14])
C0077163 (UMLS CUI [15])
C0020517 (UMLS CUI [16,1])
C0215136 (UMLS CUI [16,2])
C0005064 (UMLS CUI [17])
C0018546 (UMLS CUI [18])
C0013136 (UMLS CUI [19])
C0039663 (UMLS CUI [20])
C0068333 (UMLS CUI [21])
C3653708 (UMLS CUI [22])
C0020268 (UMLS CUI [23])
C0025815 (UMLS CUI [24])
C0032952 (UMLS CUI [25])
C0304604 (UMLS CUI [26])
C2065041 (UMLS CUI [27])
Vomiting | Retching | Nausea CTCAE Grades
Item
any vomiting, retching or nci common toxicity criteria version 3.0 grade 2-4 nausea in the 24 hours preceding chemotherapy
boolean
C0042963 (UMLS CUI [1])
C0232602 (UMLS CUI [2])
C0027497 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
Vomiting Etiology Organ system
Item
ongoing vomiting from any organic etiology
boolean
C0042963 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0460002 (UMLS CUI [1,3])
CORTICOSTEROIDS FOR SYSTEMIC USE Patient need for | Chemotherapy | Prophylactic treatment Chemotherapy Toxicity | Topical form corticosteroids | inhaled steroids
Item
need to receive systemic corticosteroids, except: a) when defined as part of the chemotherapy regimen as a preventative measure for chemotherapy toxicities; b) topical or inhaled preparations; and/or c) when used as rescue medication during the study
boolean
C3653708 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0199176 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0600688 (UMLS CUI [3,3])
C0304604 (UMLS CUI [4])
C2065041 (UMLS CUI [5])
Medical contraindication 5-HT>3< receptor antagonist | Medical contraindication palonosetron | Medical contraindication Dexamethasone
Item
known contraindication to 5-ht3 receptor antagonists (including palonosetron) or dexamethasone
boolean
C1301624 (UMLS CUI [1,1])
C0360055 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0220578 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0011777 (UMLS CUI [3,2])
Therapeutic radiology procedure Patient need for
Item
need to receive radiotherapy during the study
boolean
C1522449 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Protocol Compliance Unable
Item
inability to understand or cooperate with study procedures
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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