ID

35012

Beschrijving

Acupuncture to Reduce Chemotherapy-induced Peripheral Neuropathy Severity During Neoadjuvant or Adjuvant Weekly Paclitaxel Chemotherapy in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02364726

Link

https://clinicaltrials.gov/show/NCT02364726

Trefwoorden

Versies (1)
  1. 08-02-19 08-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02364726

Engels

Eligibility Breast Cancer NCT02364726

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
screening phase:
Beschrijving

Screening Phase

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C1710475
age 21 or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically proven stage i-iii carcinoma of the breast.
Beschrijving

Breast Carcinoma TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
plan to receive adjuvant or neoadjuvant chemotherapy that includes weekly paclitaxel.
Beschrijving

Adjuvant Chemotherapy Planned | Chemotherapy Neoadjuvant Planned | Paclitaxel Weekly

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0144576
UMLS CUI [3,2]
C0332174
eastern cooperative oncology group performance status 0-2 (see appendix b).
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
the patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
proficiency in english with the ability to speak and read english.
Beschrijving

Able to speak English Language | Able to read English Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
intervention phase:
Beschrijving

Intervention Phase

Datatype

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1710475
age 21 or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically proven stage i-iii carcinoma of the breast.
Beschrijving

Breast Carcinoma TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
receiving adjuvant or neoadjuvant chemotherapy that includes a taxane.
Beschrijving

Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant | taxane

Datatype

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0600558
UMLS CUI [3]
C0215136
eastern cooperative oncology group performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
the patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
proficiency in english with the ability to speak and read english
Beschrijving

Able to speak English Language | Able to read English Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
while on neurotoxic chemotherapy, has developed nci-ctc grade 2 cipn
Beschrijving

Chemotherapy | Neurotoxicity CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C0235032
UMLS CUI [2,2]
C1516728
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known metastatic (stage iv) breast cancer involvement.
Beschrijving

Secondary malignant neoplasm of female breast Involvement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C1314939
pre-existing peripheral neuropathy before chemotherapy is initiated.
Beschrijving

Peripheral Neuropathy Pre-existing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine, or glutamine.
Beschrijving

Pharmaceutical Preparations Against Neuropathy | gabapentin | pregabalin | duloxetine | Glutamine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0442874
UMLS CUI [2]
C0060926
UMLS CUI [3]
C0657912
UMLS CUI [4]
C0245561
UMLS CUI [5]
C0017797
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Similar models

Eligibility Breast Cancer NCT02364726

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Screening Phase
Item
screening phase:
boolean
C0220908 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
Age
Item
age 21 or older.
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
histologically proven stage i-iii carcinoma of the breast.
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Adjuvant Chemotherapy Planned | Chemotherapy Neoadjuvant Planned | Paclitaxel Weekly
Item
plan to receive adjuvant or neoadjuvant chemotherapy that includes weekly paclitaxel.
boolean
C0085533 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0144576 (UMLS CUI [3,1])
C0332174 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group performance status 0-2 (see appendix b).
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
the patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Able to speak English Language | Able to read English Language
Item
proficiency in english with the ability to speak and read english.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Intervention Phase
Item
intervention phase:
boolean
C0184661 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
Age
Item
age 21 or older.
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
histologically proven stage i-iii carcinoma of the breast.
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant | taxane
Item
receiving adjuvant or neoadjuvant chemotherapy that includes a taxane.
boolean
C0085533 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0215136 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
the patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Able to speak English Language | Able to read English Language
Item
proficiency in english with the ability to speak and read english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Chemotherapy | Neurotoxicity CTCAE Grades
Item
while on neurotoxic chemotherapy, has developed nci-ctc grade 2 cipn
boolean
C0392920 (UMLS CUI [1])
C0235032 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of female breast Involvement
Item
known metastatic (stage iv) breast cancer involvement.
boolean
C0346993 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Peripheral Neuropathy Pre-existing
Item
pre-existing peripheral neuropathy before chemotherapy is initiated.
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Pharmaceutical Preparations Against Neuropathy | gabapentin | pregabalin | duloxetine | Glutamine
Item
currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine, or glutamine.
boolean
C0013227 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0442874 (UMLS CUI [1,3])
C0060926 (UMLS CUI [2])
C0657912 (UMLS CUI [3])
C0245561 (UMLS CUI [4])
C0017797 (UMLS CUI [5])
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