Breast Carcinoma | TNM clinical staging | Solid tumour
Item
1. patients must have histologically or cytologically confirmed breast cancer, stage i, ii, iii or iv or other solid tumors.
boolean
C0678222 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
C0280100 (UMLS CUI [3])
Paclitaxel Chemotherapy | nab-paclitaxel Chemotherapy | Peripheral Neuropathy | CTCAE Grades
Item
2. patients must be receiving weekly paclitaxel or nab-paclitaxel chemotherapy or have recently completed paclitaxel or nab-paclitaxel chemotherapy and have at least a grade i peripheral neuropathy (see appendix a) because of therapy.
boolean
C0144576 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1527223 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0031117 (UMLS CUI [3])
C1516728 (UMLS CUI [4])
Age | Child | Glutamine Dose | Glutamine Adverse event
Item
3. because no dosing or adverse event data are currently available on the use of glutamine in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.
boolean
C0001779 (UMLS CUI [1])
C0008059 (UMLS CUI [2])
C0017797 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0017797 (UMLS CUI [4,1])
C0877248 (UMLS CUI [4,2])
ECOG performance status
Item
4. ecog performance status <1 (karnofsky >90%).
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
5. life expectancy of greater than 3 months.
boolean
C0023671 (UMLS CUI [1])
Organ function Sufficient Paclitaxel Therapeutic procedure | Bone Marrow function Sufficient Paclitaxel Therapeutic procedure
Item
6. patients must have sufficient organ and marrow function so that paclitaxel treatment can be administered.
boolean
C0678852 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0144576 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0205410 (UMLS CUI [2,3])
C0144576 (UMLS CUI [2,4])
C0087111 (UMLS CUI [2,5])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Pregnancy
Item
7. the effects of glutamine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C0032961 (UMLS CUI [6])
Informed Consent
Item
8. ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Neuropathy | Chemotherapy
Item
1. patients who have experienced prior neuropathies not associated with chemotherapy
boolean
C0442874 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Investigational New Drugs
Item
2. patients may not be receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Prognosis bad | Progressive Neurologic dysfunction Affecting Evaluation Adverse event Neurologic | Progressive Neurologic dysfunction Affecting Evaluation Adverse event
Item
3. patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
boolean
C0220650 (UMLS CUI [1])
C0278252 (UMLS CUI [2])
C4013375 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C0877248 (UMLS CUI [3,4])
C0205494 (UMLS CUI [3,5])
C4013375 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0877248 (UMLS CUI [4,4])
Hypersensitivity Glutamine
Item
4. there are no known allergies associated with glutamine.
boolean
C0020517 (UMLS CUI [1,1])
C0017797 (UMLS CUI [1,2])
Illness Uncontrolled | Ineligibility Paclitaxel Chemotherapy Related
Item
5. uncontrolled intercurrent illness that render the patient ineligible to receive paclitaxel chemotherapy.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1512714 (UMLS CUI [2,1])
C0144576 (UMLS CUI [2,2])
C3665472 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
Pregnancy At risk Adverse event Secondary to Glutamine | Breast Feeding Discontinued Due to Glutamine
Item
6. pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with glutamine. breastfeeding should also be discontinued if the mother is treated with glutamine.
boolean
C0032961 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0175668 (UMLS CUI [1,4])
C0017797 (UMLS CUI [1,5])
C0006147 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0017797 (UMLS CUI [2,4])
Immunologic Deficiency At risk Increased Communicable Diseases Lethal | Therapeutic Bone Marrow Suppression | HIV Seropositivity Receiving antiretroviral combinations | Pharmacokinetic interaction Glutamine Related
Item
7. because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with glutamine. appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
boolean
C0021051 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,3])
C0009450 (UMLS CUI [1,4])
C3151529 (UMLS CUI [1,5])
C2698538 (UMLS CUI [2])
C0019699 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C2193864 (UMLS CUI [3,3])
C1868980 (UMLS CUI [4,1])
C0017797 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
Chemotherapy Investigational New Drug Causing Neuropathy | Cisplatin | Carboplatin | oxaliplatin
Item
8. concurrent chemotherapy with another drug known to cause neuropathy (cddp or cbdca or oxaliplatin) are excluded.
boolean
C0392920 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C0442874 (UMLS CUI [1,4])
C0008838 (UMLS CUI [2])
C0079083 (UMLS CUI [3])
C0069717 (UMLS CUI [4])