ID

18848

Description

Randomized Placebo-Controlled Trial of Glutamine for Breast Cancer Patients With Peripheral Neuropathy; ODM derived from: https://clinicaltrials.gov/show/NCT00195013

Link

https://clinicaltrials.gov/show/NCT00195013

Keywords

Versions (1)
  1. 11/23/16 11/23/16 -
Uploaded on

November 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Peripheral Neuropathy NCT00195013

English

Eligibility Peripheral Neuropathy NCT00195013

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have histologically or cytologically confirmed breast cancer, stage i, ii, iii or iv or other solid tumors.
Description

Breast Carcinoma | TNM clinical staging | Solid tumour

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C3258246
UMLS CUI [3]
C0280100
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.
Description

Paclitaxel Chemotherapy | nab-paclitaxel Chemotherapy | Peripheral Neuropathy | CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0144576
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C1527223
UMLS CUI [2,2]
C0392920
UMLS CUI [3]
C0031117
UMLS CUI [4]
C1516728
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.
Description

Age | Child | Glutamine Dose | Glutamine Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0008059
UMLS CUI [3,1]
C0017797
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0017797
UMLS CUI [4,2]
C0877248
4. ecog performance status <1 (karnofsky >90%).
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. life expectancy of greater than 3 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
6. patients must have sufficient organ and marrow function so that paclitaxel treatment can be administered.
Description

Organ function Sufficient Paclitaxel Therapeutic procedure | Bone Marrow function Sufficient Paclitaxel Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C0144576
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [2,3]
C0205410
UMLS CUI [2,4]
C0144576
UMLS CUI [2,5]
C0087111
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.
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0032961
8. ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have experienced prior neuropathies not associated with chemotherapy
Description

Neuropathy | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0442874
UMLS CUI [2]
C0392920
2. patients may not be receiving any other investigational agents.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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.
Description

Metastatic malignant neoplasm to brain | Prognosis bad | Progressive Neurologic dysfunction Affecting Evaluation Adverse event Neurologic | Progressive Neurologic dysfunction Affecting Evaluation Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0278252
UMLS CUI [3,1]
C4013375
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1261322
UMLS CUI [3,4]
C0877248
UMLS CUI [3,5]
C0205494
UMLS CUI [4,1]
C4013375
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C1261322
UMLS CUI [4,4]
C0877248
4. there are no known allergies associated with glutamine.
Description

Hypersensitivity Glutamine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0017797
5. uncontrolled intercurrent illness that render the patient ineligible to receive paclitaxel chemotherapy.
Description

Illness Uncontrolled | Ineligibility Paclitaxel Chemotherapy Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C0144576
UMLS CUI [2,3]
C3665472
UMLS CUI [2,4]
C0439849
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.
Description

Pregnancy At risk Adverse event Secondary to Glutamine | Breast Feeding Discontinued Due to Glutamine

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C0175668
UMLS CUI [1,5]
C0017797
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0017797
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.
Description

Immunologic Deficiency At risk Increased Communicable Diseases Lethal | Therapeutic Bone Marrow Suppression | HIV Seropositivity Receiving antiretroviral combinations | Pharmacokinetic interaction Glutamine Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0205217
UMLS CUI [1,4]
C0009450
UMLS CUI [1,5]
C3151529
UMLS CUI [2]
C2698538
UMLS CUI [3,1]
C0019699
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C2193864
UMLS CUI [4,1]
C1868980
UMLS CUI [4,2]
C0017797
UMLS CUI [4,3]
C0439849
8. concurrent chemotherapy with another drug known to cause neuropathy (cddp or cbdca or oxaliplatin) are excluded.
Description

Chemotherapy Investigational New Drug Causing Neuropathy | Cisplatin | Carboplatin | oxaliplatin

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C0442874
UMLS CUI [2]
C0008838
UMLS CUI [3]
C0079083
UMLS CUI [4]
C0069717
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Similar models

Eligibility Peripheral Neuropathy NCT00195013

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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