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])
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])