ID

16005

Description

The Use of Pentoxifylline and Vitamin E in the Treatment of Chronic Breast Pain; ODM derived from: https://clinicaltrials.gov/show/NCT00188669

Link

https://clinicaltrials.gov/show/NCT00188669

Keywords

  1. 5/5/16 5/5/16 -
  2. 6/26/16 6/26/16 -
Uploaded on

June 26, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT00188669

Eligibility Breast Neoplasms NCT00188669

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
uicc tnm stage 0 (i.e. in situ disease), 1 or 2 breast cancer patients treated with conservative surgery and adjuvant radiotherapy with chronic breast pain or tenderness, with or without fibrosis, within 3 months to 3 years following completion of radiotherapy
Description

breast cancer tnm stage

Data type

boolean

Alias
UMLS CUI [1]
C0150055
UMLS CUI [2]
C0234233
age 18 to 75 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
chronic symptoms localised to the breast treated with radiation, i.e. any one or more of the following- pain (not attributable to infection) or tenderness with or without associated oedema, fibrosis, necrosis or ulceration.
Description

chronic symptoms like pain, tenderness, fibrosis, necrosis or ulceration

Data type

boolean

Alias
UMLS CUI [1]
C0156323
breast pain (maximum in the previous 24 hours) measurable on a linear analogue scale with a length of 3cm or greater
Description

breast pain

Data type

boolean

Alias
UMLS CUI [1]
C0024902
prior treatment with radiation to the affected area i.e. in tangential breast fields or boost area
Description

prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
radiation completed at least 3 months and no longer than 3 years prior to study entry
Description

radiation completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1522449
informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active cellulitis in the breast
Description

Cellulitis of breast

Data type

boolean

Alias
UMLS CUI [1]
C0392003
active malignant disease
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
any medical illness or condition judged likely by the local investigator to preclude safe administration of protocol treatment
Description

comorbidity not influencing protocol treatment

Data type

boolean

Alias
UMLS CUI [1]
C0009488
contraindication to treatment with pentoxifylline (i.e. previously exhibited intolerance to pentoxifylline or other xanthines such as caffeine, theophylline or theobromine; recent cerebral and/or retinal haemorrhage; ischaemic heart disease; hypotension
Description

contraindication to pentoxifylline

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0030899
pregnant or lactating women
Description

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147

Similar models

Eligibility Breast Neoplasms NCT00188669

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
breast cancer tnm stage
Item
uicc tnm stage 0 (i.e. in situ disease), 1 or 2 breast cancer patients treated with conservative surgery and adjuvant radiotherapy with chronic breast pain or tenderness, with or without fibrosis, within 3 months to 3 years following completion of radiotherapy
boolean
C0150055 (UMLS CUI [1])
C0234233 (UMLS CUI [2])
age
Item
age 18 to 75 years of age
boolean
C0001779 (UMLS CUI [1])
chronic symptoms like pain, tenderness, fibrosis, necrosis or ulceration
Item
chronic symptoms localised to the breast treated with radiation, i.e. any one or more of the following- pain (not attributable to infection) or tenderness with or without associated oedema, fibrosis, necrosis or ulceration.
boolean
C0156323 (UMLS CUI [1])
breast pain
Item
breast pain (maximum in the previous 24 hours) measurable on a linear analogue scale with a length of 3cm or greater
boolean
C0024902 (UMLS CUI [1])
prior radiation therapy
Item
prior treatment with radiation to the affected area i.e. in tangential breast fields or boost area
boolean
C1522449 (UMLS CUI [1])
radiation completed
Item
radiation completed at least 3 months and no longer than 3 years prior to study entry
boolean
C0011008 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
informed consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cellulitis of breast
Item
active cellulitis in the breast
boolean
C0392003 (UMLS CUI [1])
Malignant Neoplasms
Item
active malignant disease
boolean
C0006826 (UMLS CUI [1])
comorbidity not influencing protocol treatment
Item
any medical illness or condition judged likely by the local investigator to preclude safe administration of protocol treatment
boolean
C0009488 (UMLS CUI [1])
contraindication to pentoxifylline
Item
contraindication to treatment with pentoxifylline (i.e. previously exhibited intolerance to pentoxifylline or other xanthines such as caffeine, theophylline or theobromine; recent cerebral and/or retinal haemorrhage; ischaemic heart disease; hypotension
boolean
C1301624 (UMLS CUI [1,1])
C0030899 (UMLS CUI [1,2])
pregnant or lactating
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])

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