ID

42529

Beschreibung

A Pilot Study of Acupuncture for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02129686

Link

https://clinicaltrials.gov/show/NCT02129686

Stichworte

Versionen (1)
  1. 18.08.21 18.08.21 -
Rechteinhaber

Dana-Farber Cancer Institute The Comprehensive and Integrative Medicine Institute of South Korea

Hochgeladen am

18. August 2021

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Eligibility Taxane-induced Peripheral Neuropathy NCT02129686

Englisch

Eligibility Taxane-induced Peripheral Neuropathy NCT02129686

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of histologically or cytologically proven breast cancer at stage i, ii and iii, without evidence of distant metastasis;
Beschreibung

History of histologically or cytologically proven breast cancer, staging | Absence of distant metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0010819
UMLS CUI [1,3]
C0750484
UMLS CUI [1,4]
C1300072
UMLS CUI [1,5]
C0027627
UMLS CUI [1,6]
C0332197
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0019638
UMLS CUI [2,3]
C0750484
UMLS CUI [2,4]
C1300072
UMLS CUI [2,5]
C0027627
UMLS CUI [2,6]
C0332197
completed adjuvant taxane-based chemotherapy as single agents or in combination with platins or her-2 directed therapy
Beschreibung

Adjuvant taxane-based chemotherapy in monotherapy or in combination with platins or HER-2 directed therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0215136
UMLS CUI [1,3]
C4763675
UMLS CUI [1,4]
C0205197
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0215136
UMLS CUI [2,3]
C0032207
UMLS CUI [2,4]
C0205195
UMLS CUI [2,5]
C0205197
UMLS CUI [3,1]
C0085533
UMLS CUI [3,2]
C0215136
UMLS CUI [3,3]
C1954282
UMLS CUI [3,4]
C2985566
UMLS CUI [3,5]
C0205195
UMLS CUI [3,6]
C0205197
reporting grade 1 or greater of the following symptoms persistently for more than 2 weeks: neuropathic pain, allodynia, areflexia, dysesthesia, paresthesia, hyperesthesia, hypoesthesia or glove and stocking syndrome as defined by common terminology criteria for adverse events (ctcae v. 4.03) (table 1 and the screening checklist);
Beschreibung

Neuropathic pain | Allodynia | Areflexia | Dysesthesia | Paresthesia | Hyperesthesia | Hypoesthesia | Glove and stocking syndrome as defined by CTCAE

Datentyp

boolean

Alias
UMLS CUI [1]
C3714625
UMLS CUI [2]
C0458247
UMLS CUI [3]
C0234146
UMLS CUI [4]
C0392699
UMLS CUI [5]
C0030554
UMLS CUI [6]
C0020453
UMLS CUI [7]
C0020580
UMLS CUI [8,1]
C0746874
UMLS CUI [8,2]
C1516728
patients who are currently on stable prescription medications or dietary supplements for cipn and still symptomatic as defined above will be allowed to participate in the study. related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; nsaids; glutamine, glutathione, vitamin e and vitamin b12;
Beschreibung

Stable dose of following is allowed: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; nsaids; glutamine, glutathione, vitamin e and vitamin b12

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0060926
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0657912
UMLS CUI [2,2]
C0683607
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0028420
UMLS CUI [3,2]
C0683607
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0002600
UMLS CUI [4,2]
C0683607
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C0245561
UMLS CUI [5,2]
C0683607
UMLS CUI [5,3]
C0205360
UMLS CUI [6,1]
C0078569
UMLS CUI [6,2]
C0683607
UMLS CUI [6,3]
C0205360
UMLS CUI [7,1]
C0023660
UMLS CUI [7,2]
C0683607
UMLS CUI [7,3]
C0205360
UMLS CUI [8,1]
C0040610
UMLS CUI [8,2]
C0683607
UMLS CUI [8,3]
C0205360
UMLS CUI [9,1]
C0027415
UMLS CUI [9,2]
C0205394
UMLS CUI [9,3]
C0683607
UMLS CUI [9,4]
C0205360
UMLS CUI [10,1]
C0003211
UMLS CUI [10,2]
C0683607
UMLS CUI [10,3]
C0205360
UMLS CUI [11,1]
C0017797
UMLS CUI [11,2]
C0683607
UMLS CUI [11,3]
C0205360
UMLS CUI [12,1]
C0017817
UMLS CUI [12,2]
C0683607
UMLS CUI [12,3]
C0205360
UMLS CUI [13,1]
C0042874
UMLS CUI [13,2]
C0683607
UMLS CUI [13,3]
C0205360
UMLS CUI [14,1]
C0042845
UMLS CUI [14,2]
C0683607
UMLS CUI [14,3]
C0205360
age ≥ 18 years;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status of 0 or 1;
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematological function: neutrophil count >1.0 x109/l, platelet count >50x109/l;
Beschreibung

Neutrophil count | Platelet count

Datentyp

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
signed informed consent.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
Beschreibung

Unstable cardiac disease | Recent myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0027051
UMLS CUI [2,2]
C0332185
wearing a pacemaker or implantable cardioverter-defibrillator; uncontrolled seizure disorder;
Beschreibung

Pacemaker | Implantable cardioverter-defibrillator | Uncontrolled seizure disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0162589
UMLS CUI [3,1]
C0036572
UMLS CUI [3,2]
C0205318
history of pre-existing peripheral neuropathy prior to chemotherapy, including alcoholism, vitamin b deficiency, diabetes, hiv, congenital neuropathy, toxic neuropathy;
Beschreibung

History of pre-existing peripheral neuropathy prior to chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0031117
UMLS CUI [1,3]
C2347662
UMLS CUI [1,4]
C0392920
UMLS CUI [1,5]
C0332152
peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma;
Beschreibung

Peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C0332448
UMLS CUI [2,1]
C0031117
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0037926
UMLS CUI [3,1]
C0031117
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0543467
UMLS CUI [3,4]
C3714660
pregnancy or potential pregnancy and nursing;
Beschreibung

Pregnancy | Childbearing Potential | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0006147
active clinically significant uncontrolled infection;
Beschreibung

Active clinically significant uncontrolled infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C2826293
UMLS CUI [1,4]
C0205177
prior use of acupuncture for cipn within 6 months prior to study entry;
Beschreibung

Recent prior use of acupuncture for CIPN

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0394664
UMLS CUI [1,2]
C3873567
UMLS CUI [1,3]
C0332185
patients with uncontrolled major psychiatric disorders, such as major depression or psychosis, will not be eligible for this trial. patients with a history of depression or anxiety who are stable on or off psychiatric medications will be eligible.
Beschreibung

Uncontrolled mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
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Ähnliche Modelle

Eligibility Taxane-induced Peripheral Neuropathy NCT02129686

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
History of histologically or cytologically proven breast cancer, staging | Absence of distant metastasis
Item
history of histologically or cytologically proven breast cancer at stage i, ii and iii, without evidence of distant metastasis;
boolean
C0678222 (UMLS CUI [1,1])
C0010819 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C1300072 (UMLS CUI [1,4])
C0027627 (UMLS CUI [1,5])
C0332197 (UMLS CUI [1,6])
C0678222 (UMLS CUI [2,1])
C0019638 (UMLS CUI [2,2])
C0750484 (UMLS CUI [2,3])
C1300072 (UMLS CUI [2,4])
C0027627 (UMLS CUI [2,5])
C0332197 (UMLS CUI [2,6])
Adjuvant taxane-based chemotherapy in monotherapy or in combination with platins or HER-2 directed therapy
Item
completed adjuvant taxane-based chemotherapy as single agents or in combination with platins or her-2 directed therapy
boolean
C0085533 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
C4763675 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0085533 (UMLS CUI [2,1])
C0215136 (UMLS CUI [2,2])
C0032207 (UMLS CUI [2,3])
C0205195 (UMLS CUI [2,4])
C0205197 (UMLS CUI [2,5])
C0085533 (UMLS CUI [3,1])
C0215136 (UMLS CUI [3,2])
C1954282 (UMLS CUI [3,3])
C2985566 (UMLS CUI [3,4])
C0205195 (UMLS CUI [3,5])
C0205197 (UMLS CUI [3,6])
Neuropathic pain | Allodynia | Areflexia | Dysesthesia | Paresthesia | Hyperesthesia | Hypoesthesia | Glove and stocking syndrome as defined by CTCAE
Item
reporting grade 1 or greater of the following symptoms persistently for more than 2 weeks: neuropathic pain, allodynia, areflexia, dysesthesia, paresthesia, hyperesthesia, hypoesthesia or glove and stocking syndrome as defined by common terminology criteria for adverse events (ctcae v. 4.03) (table 1 and the screening checklist);
boolean
C3714625 (UMLS CUI [1])
C0458247 (UMLS CUI [2])
C0234146 (UMLS CUI [3])
C0392699 (UMLS CUI [4])
C0030554 (UMLS CUI [5])
C0020453 (UMLS CUI [6])
C0020580 (UMLS CUI [7])
C0746874 (UMLS CUI [8,1])
C1516728 (UMLS CUI [8,2])
Stable dose of following is allowed: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; nsaids; glutamine, glutathione, vitamin e and vitamin b12
Item
patients who are currently on stable prescription medications or dietary supplements for cipn and still symptomatic as defined above will be allowed to participate in the study. related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; nsaids; glutamine, glutathione, vitamin e and vitamin b12;
boolean
C0060926 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0657912 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0028420 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0002600 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0245561 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0078569 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0023660 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
C0040610 (UMLS CUI [8,1])
C0683607 (UMLS CUI [8,2])
C0205360 (UMLS CUI [8,3])
C0027415 (UMLS CUI [9,1])
C0205394 (UMLS CUI [9,2])
C0683607 (UMLS CUI [9,3])
C0205360 (UMLS CUI [9,4])
C0003211 (UMLS CUI [10,1])
C0683607 (UMLS CUI [10,2])
C0205360 (UMLS CUI [10,3])
C0017797 (UMLS CUI [11,1])
C0683607 (UMLS CUI [11,2])
C0205360 (UMLS CUI [11,3])
C0017817 (UMLS CUI [12,1])
C0683607 (UMLS CUI [12,2])
C0205360 (UMLS CUI [12,3])
C0042874 (UMLS CUI [13,1])
C0683607 (UMLS CUI [13,2])
C0205360 (UMLS CUI [13,3])
C0042845 (UMLS CUI [14,1])
C0683607 (UMLS CUI [14,2])
C0205360 (UMLS CUI [14,3])
Age
Item
age ≥ 18 years;
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1;
boolean
C1520224 (UMLS CUI [1])
Neutrophil count | Platelet count
Item
adequate hematological function: neutrophil count >1.0 x109/l, platelet count >50x109/l;
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Informed consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Unstable cardiac disease | Recent myocardial infarction
Item
unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
boolean
C0018799 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Pacemaker | Implantable cardioverter-defibrillator | Uncontrolled seizure disorder
Item
wearing a pacemaker or implantable cardioverter-defibrillator; uncontrolled seizure disorder;
boolean
C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
C0036572 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
History of pre-existing peripheral neuropathy prior to chemotherapy
Item
history of pre-existing peripheral neuropathy prior to chemotherapy, including alcoholism, vitamin b deficiency, diabetes, hiv, congenital neuropathy, toxic neuropathy;
boolean
C0262926 (UMLS CUI [1,1])
C0031117 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,4])
C0332152 (UMLS CUI [1,5])
Peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma
Item
peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma;
boolean
C0031117 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0332448 (UMLS CUI [1,4])
C0031117 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0037926 (UMLS CUI [2,3])
C0031117 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
C3714660 (UMLS CUI [3,4])
Pregnancy | Childbearing Potential | Breast Feeding
Item
pregnancy or potential pregnancy and nursing;
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Active clinically significant uncontrolled infection
Item
active clinically significant uncontrolled infection;
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0205177 (UMLS CUI [1,4])
Recent prior use of acupuncture for CIPN
Item
prior use of acupuncture for cipn within 6 months prior to study entry;
boolean
C0394664 (UMLS CUI [1,1])
C3873567 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Uncontrolled mental disorders
Item
patients with uncontrolled major psychiatric disorders, such as major depression or psychosis, will not be eligible for this trial. patients with a history of depression or anxiety who are stable on or off psychiatric medications will be eligible.
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
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