ID

37775

Beschrijving

Acupuncture in Treating Nerve Pain in Patients With Stage I, Stage II, or Stage III Breast Cancer Who Are Receiving Paclitaxel; ODM derived from: https://clinicaltrials.gov/show/NCT01050075

Link

https://clinicaltrials.gov/show/NCT01050075

Trefwoorden

  1. 23-08-19 23-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01050075

Eligibility Breast Cancer NCT01050075

Criteria
Beschrijving

Criteria

patients must have a history of histologically or cytologically confirmed stage i, ii, or iii breast cancer that have received 2 cycles of paclitaxel, and expected to receive paclitaxel for two more cycles, and are experiencing grade 1 peripheral neuropathy (ctcae criteria)
Beschrijving

Breast Carcinoma TNM Breast tumor staging | Paclitaxel Course Quantity | Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0144576
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0031117
UMLS CUI [3,2]
C1516728
performance ecog 0-2 (karnofsky performance status >= 60%)
Beschrijving

ECOG performance status | Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
life expectancy of greater than 6 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
ability to understand and the willingness to sign a written informed consent document
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
exclusion
Beschrijving

Exclusion Criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
patients with radiologically confirmed stage iv breast cancer
Beschrijving

Breast Carcinoma TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
patients who had acupuncture in the previous 8 weeks
Beschrijving

Acupuncture

Datatype

boolean

Alias
UMLS CUI [1]
C0394664
change in use of any of the following drugs in the prior 4 weeks: opiates, antidepressants, or anxiolytics ("change" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen)
Beschrijving

Change of medication | Opiates | Antidepressive Agents | Anti-Anxiety Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0580105
UMLS CUI [2]
C0376196
UMLS CUI [3]
C0003289
UMLS CUI [4]
C0040616
patients with needle phobia
Beschrijving

Needle phobia

Datatype

boolean

Alias
UMLS CUI [1]
C0338906
patients who experienced any peripheral neuropathy prior to chemotherapy
Beschrijving

Peripheral Neuropathy Before Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0392920
patients who have the potential for serious bleeding due to inherited diseases such as hemophilia
Beschrijving

Potential Hemorrhage Serious | Etiology Hereditary Diseases | Etiology Hemophilia

Datatype

boolean

Alias
UMLS CUI [1,1]
C3245505
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0019247
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0684275
patients with diabetes
Beschrijving

Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0011849

Similar models

Eligibility Breast Cancer NCT01050075

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Breast Carcinoma TNM Breast tumor staging | Paclitaxel Course Quantity | Peripheral Neuropathy CTCAE Grades
Item
patients must have a history of histologically or cytologically confirmed stage i, ii, or iii breast cancer that have received 2 cycles of paclitaxel, and expected to receive paclitaxel for two more cycles, and are experiencing grade 1 peripheral neuropathy (ctcae criteria)
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0144576 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0031117 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
ECOG performance status | Karnofsky Performance Status
Item
performance ecog 0-2 (karnofsky performance status >= 60%)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Life Expectancy
Item
life expectancy of greater than 6 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion
boolean
C0680251 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
patients with radiologically confirmed stage iv breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Acupuncture
Item
patients who had acupuncture in the previous 8 weeks
boolean
C0394664 (UMLS CUI [1])
Change of medication | Opiates | Antidepressive Agents | Anti-Anxiety Agents
Item
change in use of any of the following drugs in the prior 4 weeks: opiates, antidepressants, or anxiolytics ("change" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen)
boolean
C0580105 (UMLS CUI [1])
C0376196 (UMLS CUI [2])
C0003289 (UMLS CUI [3])
C0040616 (UMLS CUI [4])
Needle phobia
Item
patients with needle phobia
boolean
C0338906 (UMLS CUI [1])
Peripheral Neuropathy Before Chemotherapy
Item
patients who experienced any peripheral neuropathy prior to chemotherapy
boolean
C0031117 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Potential Hemorrhage Serious | Etiology Hereditary Diseases | Etiology Hemophilia
Item
patients who have the potential for serious bleeding due to inherited diseases such as hemophilia
boolean
C3245505 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0019247 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0684275 (UMLS CUI [3,2])
Diabetes Mellitus
Item
patients with diabetes
boolean
C0011849 (UMLS CUI [1])

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