ID

38139

Descrição

Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis; ODM derived from: https://clinicaltrials.gov/show/NCT01923220

Link

https://clinicaltrials.gov/show/NCT01923220

Palavras-chave

Versões (1)
  1. 21/09/2019 21/09/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

21 de setembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01923220

Inglês

Eligibility Breast Cancer NCT01923220

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients 18 years old and above.
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histology confirmed unilateral breast cancer following lumpectomy
Descrição

Unilateral Breast Neoplasm Following Segmental Mastectomy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4018978
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0024885
planned to receive 50 gy, whole breast xrt and regional lymph nodes radiation.
Descrição

X-ray beam therapy Whole breast Planned | Irradiation of lymph nodes regional Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0436209
UMLS CUI [1,2]
C0457102
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C2169077
UMLS CUI [2,2]
C0205147
UMLS CUI [2,3]
C1301732
ecog performance status 0-2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
completed chemotherapy 3 weeks prior to xrt (if applicable)
Descrição

Chemotherapy Completed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205197
patient should be available for the entire study period, and be able and willing to adhere to protocol requirements;
Descrição

Patient Available Planned Trial Duration | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C4288390
UMLS CUI [2]
C0525058
patient must sign an informed consent form prior to undergoing any study-related procedures
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known uncontrolled diabetes
Descrição

Diabetic - poor control

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0421258
prior radiation to breast
Descrição

Irradiation of breast Previous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2148528
UMLS CUI [1,2]
C0205156
known connective tissue disorder
Descrição

Connective Tissue Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009782
known skin disease over the treated breast
Descrição

Dermatologic disorder Breast Treated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C1522326
prior burn over treated area
Descrição

Burn Previous | Area Treated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006434
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0205146
UMLS CUI [2,2]
C1522326
evidence of infection or inflammation of breast to be treated.
Descrição

Communicable Disease Breast Treating | Inflammation Breast Treating

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C0021368
UMLS CUI [2,2]
C0006141
UMLS CUI [2,3]
C1522326
receiving biological therapy or hormone therapy (other than herceptin) during radiation treatment/study duration and 4 weeks prior to study entry.
Descrição

Biological treatment | Hormone Therapy | Exception Herceptin | Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1531518
UMLS CUI [2]
C0279025
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0338204
UMLS CUI [4]
C1522449
pre-existing skin breakdown within the planned radiotherapy field at the time of study entry.
Descrição

Broken skin Radiation Field Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0150077
UMLS CUI [1,2]
C1882536
UMLS CUI [1,3]
C1301732
pregnancy, planned pregnancy, lactation or inadequate contraception as judged by the investigator.
Descrição

Pregnancy | Pregnancy, Planned | Breast Feeding | Contraceptive methods Inadequate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0205412
participation in another investigational drug or vaccine trial concurrently or within 30 days.
Descrição

Study Subject Participation Status | Clinical Trial Investigational New Drugs | Clinical Trial Vaccines

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0042210
use of any other topical or systemic treatments aimed at radiation dermatitis.
Descrição

Topical Administration of treatment Radiodermatitis | Systemic therapy Radiodermatitis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001566
UMLS CUI [1,2]
C0034561
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0034561
use of a prescription or over-the-counter medication that contains hydrocortisone or any other cortisone or corticosteroid containing preparation
Descrição

Hydrocortisone | Hydrocortisone Non-Prescription Drugs | Pharmaceutical Preparations Containing Cortisone | Pharmaceutical Preparations Containing Adrenal Cortex Hormones

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020268
UMLS CUI [2,1]
C0020268
UMLS CUI [2,2]
C0013231
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0010137
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0332256
UMLS CUI [4,3]
C0001617
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Similar models

Eligibility Breast Cancer NCT01923220

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients 18 years old and above.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Unilateral Breast Neoplasm Following Segmental Mastectomy
Item
histology confirmed unilateral breast cancer following lumpectomy
boolean
C4018978 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0024885 (UMLS CUI [1,3])
X-ray beam therapy Whole breast Planned | Irradiation of lymph nodes regional Planned
Item
planned to receive 50 gy, whole breast xrt and regional lymph nodes radiation.
boolean
C0436209 (UMLS CUI [1,1])
C0457102 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C2169077 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Chemotherapy Completed
Item
completed chemotherapy 3 weeks prior to xrt (if applicable)
boolean
C0392920 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Patient Available Planned Trial Duration | Protocol Compliance
Item
patient should be available for the entire study period, and be able and willing to adhere to protocol requirements;
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C4288390 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2])
Informed Consent
Item
patient must sign an informed consent form prior to undergoing any study-related procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetic - poor control
Item
known uncontrolled diabetes
boolean
C0421258 (UMLS CUI [1])
Irradiation of breast Previous
Item
prior radiation to breast
boolean
C2148528 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Connective Tissue Disease
Item
known connective tissue disorder
boolean
C0009782 (UMLS CUI [1])
Dermatologic disorder Breast Treated
Item
known skin disease over the treated breast
boolean
C0037274 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
Burn Previous | Area Treated
Item
prior burn over treated area
boolean
C0006434 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205146 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Communicable Disease Breast Treating | Inflammation Breast Treating
Item
evidence of infection or inflammation of breast to be treated.
boolean
C0009450 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C0021368 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Biological treatment | Hormone Therapy | Exception Herceptin | Therapeutic radiology procedure
Item
receiving biological therapy or hormone therapy (other than herceptin) during radiation treatment/study duration and 4 weeks prior to study entry.
boolean
C1531518 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0338204 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4])
Broken skin Radiation Field Planned
Item
pre-existing skin breakdown within the planned radiotherapy field at the time of study entry.
boolean
C0150077 (UMLS CUI [1,1])
C1882536 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned | Breast Feeding | Contraceptive methods Inadequate
Item
pregnancy, planned pregnancy, lactation or inadequate contraception as judged by the investigator.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0205412 (UMLS CUI [4,2])
Study Subject Participation Status | Clinical Trial Investigational New Drugs | Clinical Trial Vaccines
Item
participation in another investigational drug or vaccine trial concurrently or within 30 days.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0008976 (UMLS CUI [3,1])
C0042210 (UMLS CUI [3,2])
Topical Administration of treatment Radiodermatitis | Systemic therapy Radiodermatitis
Item
use of any other topical or systemic treatments aimed at radiation dermatitis.
boolean
C0001566 (UMLS CUI [1,1])
C0034561 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0034561 (UMLS CUI [2,2])
Hydrocortisone | Hydrocortisone Non-Prescription Drugs | Pharmaceutical Preparations Containing Cortisone | Pharmaceutical Preparations Containing Adrenal Cortex Hormones
Item
use of a prescription or over-the-counter medication that contains hydrocortisone or any other cortisone or corticosteroid containing preparation
boolean
C0020268 (UMLS CUI [1])
C0020268 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0010137 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0332256 (UMLS CUI [4,2])
C0001617 (UMLS CUI [4,3])
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