ID

35012

Description

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

Keywords

Versions (1)
  1. 2/8/19 2/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02364726

English

Eligibility Breast Cancer NCT02364726

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
screening phase:
Description

Screening Phase

Data type

boolean

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

Age

Data type

boolean

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

Breast Carcinoma TNM Breast tumor staging

Data type

boolean

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

Adjuvant Chemotherapy Planned | Chemotherapy Neoadjuvant Planned | Paclitaxel Weekly

Data type

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).
Description

ECOG performance status

Data type

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.
Description

Informed Consent

Data type

boolean

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

Able to speak English Language | Able to read English Language

Data type

boolean

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

Intervention Phase

Data type

boolean

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

Age

Data type

boolean

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

Breast Carcinoma TNM Breast tumor staging

Data type

boolean

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

Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant | taxane

Data type

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
Description

ECOG performance status

Data type

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.
Description

Informed Consent

Data type

boolean

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

Able to speak English Language | Able to read English Language

Data type

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
Description

Chemotherapy | Neurotoxicity CTCAE Grades

Data type

boolean

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

Exclusion Criteria

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

Secondary malignant neoplasm of female breast Involvement

Data type

boolean

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

Peripheral Neuropathy Pre-existing

Data type

boolean

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

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

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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