0 Ratings
ID

39365

Description

Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01941992

Link

https://clinicaltrials.gov/show/NCT01941992

Keywords

Versions (1)
  1. 1/2/20 1/2/20 -
Copyright Holder

See clinicaltrials.gov

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January 2, 2020

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License

Creative Commons BY 4.0
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    Eligibility Head-and-neck Squamous Cell Carcinoma NCT01941992

    English

    Eligibility Head-and-neck Squamous Cell Carcinoma NCT01941992

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologically proven squamous cell carcinomas of the head-and-neck
    Description

    Squamous cell carcinoma of the head and neck

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1168401
    eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx
    Description

    Primary tumor site | Oral cavity | Oropharynx | Larynx | Hypopharynx

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0475447
    UMLS CUI [2]
    C0226896
    UMLS CUI [3]
    C0521367
    UMLS CUI [4]
    C0023078
    UMLS CUI [5]
    C0020629
    stage iii or iv disease without evidence of distant metastases
    Description

    Disease TNM clinical staging | Distant metastasis Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C3258246
    UMLS CUI [2,1]
    C1269798
    UMLS CUI [2,2]
    C0332197
    patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy
    Description

    Patients Appropriate Chemoradiotherapy | Induction Chemotherapy Followed by Chemoradiotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1548787
    UMLS CUI [1,3]
    C0436307
    UMLS CUI [2,1]
    C3179010
    UMLS CUI [2,2]
    C0332283
    UMLS CUI [2,3]
    C0436307
    age ≥ 18 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    karnofsky performance status ≥70
    Description

    Karnofsky Performance Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    life expectancy ≥6 months
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    able to swallow and retain oral medication
    Description

    Able to swallow Oral medication | Ability Retain Oral medication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2712086
    UMLS CUI [1,2]
    C0175795
    UMLS CUI [2,1]
    C0085732
    UMLS CUI [2,2]
    C0333118
    UMLS CUI [2,3]
    C0175795
    good state of dentition
    Description

    Dentition State Good

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011443
    UMLS CUI [1,2]
    C1442792
    UMLS CUI [1,3]
    C0205170
    patients must be available for treatment and follow-up
    Description

    Patients Available Treatment | Patients Available Follow-up

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0470187
    UMLS CUI [1,3]
    C0087111
    UMLS CUI [2,1]
    C0030705
    UMLS CUI [2,2]
    C0470187
    UMLS CUI [2,3]
    C3274571
    confirmation of adequate contraception use by the patient and/or partner
    Description

    Patients Use of Contraceptive methods | Partner Use of Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1524063
    UMLS CUI [1,3]
    C0700589
    UMLS CUI [2,1]
    C0682323
    UMLS CUI [2,2]
    C1524063
    UMLS CUI [2,3]
    C0700589
    signed informed consent
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx
    Description

    Radiotherapy to oral cavity | Prior radiation therapy Oropharynx | Prior radiation therapy Larynx | Prior radiation therapy Hypopharynx

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3888858
    UMLS CUI [2,1]
    C0279134
    UMLS CUI [2,2]
    C0521367
    UMLS CUI [3,1]
    C0279134
    UMLS CUI [3,2]
    C0023078
    UMLS CUI [4,1]
    C0279134
    UMLS CUI [4,2]
    C0020629
    serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities.
    Description

    Comorbidity Serious | Heart Disease Uncontrolled | Heart failure | Neurological anomalies Serious | Psychiatric abnormalities Serious

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [2,1]
    C0018799
    UMLS CUI [2,2]
    C0205318
    UMLS CUI [3]
    C0018801
    UMLS CUI [4,1]
    C0497552
    UMLS CUI [4,2]
    C0205404
    UMLS CUI [5,1]
    C4013650
    UMLS CUI [5,2]
    C0205404
    chronic administration of steroids or immunosuppressants
    Description

    Steroid use chronic | Immunosuppressive Agents chronic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0281991
    UMLS CUI [1,2]
    C0205191
    UMLS CUI [2,1]
    C0021081
    UMLS CUI [2,2]
    C0205191
    pregnancy.
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
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    Similar models

    Eligibility Head-and-neck Squamous Cell Carcinoma NCT01941992

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Squamous cell carcinoma of the head and neck
    Item
    histologically proven squamous cell carcinomas of the head-and-neck
    boolean
    C1168401 (UMLS CUI [1])
    Primary tumor site | Oral cavity | Oropharynx | Larynx | Hypopharynx
    Item
    eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx
    boolean
    C0475447 (UMLS CUI [1])
    C0226896 (UMLS CUI [2])
    C0521367 (UMLS CUI [3])
    C0023078 (UMLS CUI [4])
    C0020629 (UMLS CUI [5])
    Disease TNM clinical staging | Distant metastasis Absent
    Item
    stage iii or iv disease without evidence of distant metastases
    boolean
    C0012634 (UMLS CUI [1,1])
    C3258246 (UMLS CUI [1,2])
    C1269798 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    Patients Appropriate Chemoradiotherapy | Induction Chemotherapy Followed by Chemoradiotherapy
    Item
    patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy
    boolean
    C0030705 (UMLS CUI [1,1])
    C1548787 (UMLS CUI [1,2])
    C0436307 (UMLS CUI [1,3])
    C3179010 (UMLS CUI [2,1])
    C0332283 (UMLS CUI [2,2])
    C0436307 (UMLS CUI [2,3])
    Age
    Item
    age ≥ 18 years
    boolean
    C0001779 (UMLS CUI [1])
    Karnofsky Performance Status
    Item
    karnofsky performance status ≥70
    boolean
    C0206065 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy ≥6 months
    boolean
    C0023671 (UMLS CUI [1])
    Able to swallow Oral medication | Ability Retain Oral medication
    Item
    able to swallow and retain oral medication
    boolean
    C2712086 (UMLS CUI [1,1])
    C0175795 (UMLS CUI [1,2])
    C0085732 (UMLS CUI [2,1])
    C0333118 (UMLS CUI [2,2])
    C0175795 (UMLS CUI [2,3])
    Dentition State Good
    Item
    good state of dentition
    boolean
    C0011443 (UMLS CUI [1,1])
    C1442792 (UMLS CUI [1,2])
    C0205170 (UMLS CUI [1,3])
    Patients Available Treatment | Patients Available Follow-up
    Item
    patients must be available for treatment and follow-up
    boolean
    C0030705 (UMLS CUI [1,1])
    C0470187 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    C0030705 (UMLS CUI [2,1])
    C0470187 (UMLS CUI [2,2])
    C3274571 (UMLS CUI [2,3])
    Patients Use of Contraceptive methods | Partner Use of Contraceptive methods
    Item
    confirmation of adequate contraception use by the patient and/or partner
    boolean
    C0030705 (UMLS CUI [1,1])
    C1524063 (UMLS CUI [1,2])
    C0700589 (UMLS CUI [1,3])
    C0682323 (UMLS CUI [2,1])
    C1524063 (UMLS CUI [2,2])
    C0700589 (UMLS CUI [2,3])
    Informed Consent
    Item
    signed informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Radiotherapy to oral cavity | Prior radiation therapy Oropharynx | Prior radiation therapy Larynx | Prior radiation therapy Hypopharynx
    Item
    previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx
    boolean
    C3888858 (UMLS CUI [1])
    C0279134 (UMLS CUI [2,1])
    C0521367 (UMLS CUI [2,2])
    C0279134 (UMLS CUI [3,1])
    C0023078 (UMLS CUI [3,2])
    C0279134 (UMLS CUI [4,1])
    C0020629 (UMLS CUI [4,2])
    Comorbidity Serious | Heart Disease Uncontrolled | Heart failure | Neurological anomalies Serious | Psychiatric abnormalities Serious
    Item
    serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0018799 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    C0018801 (UMLS CUI [3])
    C0497552 (UMLS CUI [4,1])
    C0205404 (UMLS CUI [4,2])
    C4013650 (UMLS CUI [5,1])
    C0205404 (UMLS CUI [5,2])
    Steroid use chronic | Immunosuppressive Agents chronic
    Item
    chronic administration of steroids or immunosuppressants
    boolean
    C0281991 (UMLS CUI [1,1])
    C0205191 (UMLS CUI [1,2])
    C0021081 (UMLS CUI [2,1])
    C0205191 (UMLS CUI [2,2])
    Pregnancy
    Item
    pregnancy.
    boolean
    C0032961 (UMLS CUI [1])
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