ID

30807

Beskrivning

Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT01469429

Länk

https://clinicaltrials.gov/show/NCT01469429

Nyckelord

Versioner (1)
  1. 2018-06-21 2018-06-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma NCT01469429

Engelsk

Eligibility Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma NCT01469429

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
eligible subjects includes all adult hn cancer patients who have been previously diagnosed with stage 1-4 and in-situ squamous cell carcinoma within the past 36 months (mos); with or without further adjuvant therapy and have been determined to be disease free at the time of consent
Beskrivning

Malignant Head and Neck Neoplasm Adult | Squamous cell carcinoma TNM clinical staging | Squamous Cell Carcinoma in situ | Adjuvant therapy Additional | Adjuvant therapy Additional Absent | Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0278996
UMLS CUI [1,2]
C0001675
UMLS CUI [2,1]
C0007137
UMLS CUI [2,2]
C3258246
UMLS CUI [3]
C0334245
UMLS CUI [4,1]
C0677850
UMLS CUI [4,2]
C1524062
UMLS CUI [5,1]
C0677850
UMLS CUI [5,2]
C1524062
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0332296
patients must be able to take nutrition/medications orally
Beskrivning

Able to swallow food Orally | Able to swallow Oral medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0566359
UMLS CUI [1,2]
C0442027
UMLS CUI [2,1]
C2712086
UMLS CUI [2,2]
C0175795
have no prior history of intolerance or allergy to berry or berry-containing products
Beskrivning

Absence Intolerance Berry | Absence Hypersensitivity Berry | Absence Intolerance Berry product | Absence Hypersensitivity Berry product

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0231199
UMLS CUI [1,3]
C0005135
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C0005135
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0231199
UMLS CUI [3,3]
C0005135
UMLS CUI [3,4]
C1514468
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0020517
UMLS CUI [4,3]
C0005135
UMLS CUI [4,4]
C1514468
patients taking cyclooxygenase (cox)-1/cox-2 inhibitors (indomethacin, ibuprofen, celebrex) chronically, herbal supplements, who cannot be taken off the medication/supplement due to their clinical condition are eligible to participate in the study but should document daily doses of these medications in their logbooks
Beskrivning

Cyclooxygenase Inhibitors chronic | Cyclooxygenase 1 inhibitors chronic | Cyclooxygenase 2 Inhibitors chronic | Indomethacin chronic | Ibuprofen chronic | Celebrex chronic | Herbal Supplements | Pharmaceutical Preparations Discontinue Unsuccessful | Pharmaceutical Preparations Dose Daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085387
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0389003
UMLS CUI [2,2]
C0243077
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C1257954
UMLS CUI [3,2]
C0205191
UMLS CUI [4,1]
C0021246
UMLS CUI [4,2]
C0205191
UMLS CUI [5,1]
C0020740
UMLS CUI [5,2]
C0205191
UMLS CUI [6,1]
C0719198
UMLS CUI [6,2]
C0205191
UMLS CUI [7]
C1504473
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C1444662
UMLS CUI [8,3]
C1272705
UMLS CUI [9,1]
C0013227
UMLS CUI [9,2]
C0178602
UMLS CUI [9,3]
C0332173
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of intolerance (including hypersensitivity or allergy) to berry or berry-containing products
Beskrivning

Intolerance Berry | Hypersensitivity Berry | Intolerance Berry product | Hypersensitivity Berry product

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231199
UMLS CUI [1,2]
C0005135
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0005135
UMLS CUI [3,1]
C0231199
UMLS CUI [3,2]
C0005135
UMLS CUI [3,3]
C1514468
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0005135
UMLS CUI [4,3]
C1514468
inability to take oral nutrition/liquids or history of aspiration pneumonia
Beskrivning

Lacking Able to swallow food Orally | Lacking Able to swallow fluid Orally | Aspiration Pneumonia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0566359
UMLS CUI [1,3]
C0442027
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0566364
UMLS CUI [2,3]
C0442027
UMLS CUI [3]
C0032290
pregnant women: although there are no known adverse effects of black raspberries upon the fetus, if patients become pregnant during period of lyophilized black raspberries (lbr) administration, then lbr will be discontinued and patient will be removed from the study; we should however emphasize, given this is a food based-study, that risks are likely extremely low even though a participant should become pregnant; as such, we are not recommending active contraception for women, but rather if participants become pregnant, that they notify their study doctor, and that they will likely be removed from study; there are no expected or logical risks if men were to father a child, and as such, no contraception will be recommended for men
Beskrivning

Pregnancy | Black raspberry Adverse effects Unknown | Lyophilized Black Raspberry Lozenge To be stopped

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C1031004
UMLS CUI [2,2]
C0879626
UMLS CUI [2,3]
C0439673
UMLS CUI [3,1]
C3274577
UMLS CUI [3,2]
C1272691
inability to grant informed consent
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
strict vegetarians will be excluded from the study; it was found that consuming one portion per day of fruit or vegetables resulted in a significant decrease in oral cancer incidence; in those persons consuming multiple portions each day, there was a 50% reduction in risk; we assume that strict vegetarians will consume multiple portions each day of foods with chemopreventive activity and therefore inclusion of these individuals would have a negative impact on the study; there are several reports in the literature that herbal or multivitamin/mineral supplements have no effect on oral cancer incidence
Beskrivning

Strict vegetarian

Datatyp

boolean

Alias
UMLS CUI [1]
C3241968
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Similar models

Eligibility Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma NCT01469429

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Malignant Head and Neck Neoplasm Adult | Squamous cell carcinoma TNM clinical staging | Squamous Cell Carcinoma in situ | Adjuvant therapy Additional | Adjuvant therapy Additional Absent | Disease Free of
Item
eligible subjects includes all adult hn cancer patients who have been previously diagnosed with stage 1-4 and in-situ squamous cell carcinoma within the past 36 months (mos); with or without further adjuvant therapy and have been determined to be disease free at the time of consent
boolean
C0278996 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
C0007137 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0334245 (UMLS CUI [3])
C0677850 (UMLS CUI [4,1])
C1524062 (UMLS CUI [4,2])
C0677850 (UMLS CUI [5,1])
C1524062 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0012634 (UMLS CUI [6,1])
C0332296 (UMLS CUI [6,2])
Able to swallow food Orally | Able to swallow Oral medication
Item
patients must be able to take nutrition/medications orally
boolean
C0566359 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
C2712086 (UMLS CUI [2,1])
C0175795 (UMLS CUI [2,2])
Absence Intolerance Berry | Absence Hypersensitivity Berry | Absence Intolerance Berry product | Absence Hypersensitivity Berry product
Item
have no prior history of intolerance or allergy to berry or berry-containing products
boolean
C0332197 (UMLS CUI [1,1])
C0231199 (UMLS CUI [1,2])
C0005135 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0005135 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0231199 (UMLS CUI [3,2])
C0005135 (UMLS CUI [3,3])
C1514468 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C0020517 (UMLS CUI [4,2])
C0005135 (UMLS CUI [4,3])
C1514468 (UMLS CUI [4,4])
Cyclooxygenase Inhibitors chronic | Cyclooxygenase 1 inhibitors chronic | Cyclooxygenase 2 Inhibitors chronic | Indomethacin chronic | Ibuprofen chronic | Celebrex chronic | Herbal Supplements | Pharmaceutical Preparations Discontinue Unsuccessful | Pharmaceutical Preparations Dose Daily
Item
patients taking cyclooxygenase (cox)-1/cox-2 inhibitors (indomethacin, ibuprofen, celebrex) chronically, herbal supplements, who cannot be taken off the medication/supplement due to their clinical condition are eligible to participate in the study but should document daily doses of these medications in their logbooks
boolean
C0085387 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0389003 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C1257954 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0021246 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0020740 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C0719198 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
C1504473 (UMLS CUI [7])
C0013227 (UMLS CUI [8,1])
C1444662 (UMLS CUI [8,2])
C1272705 (UMLS CUI [8,3])
C0013227 (UMLS CUI [9,1])
C0178602 (UMLS CUI [9,2])
C0332173 (UMLS CUI [9,3])
Item Group
C0680251 (UMLS CUI)
Intolerance Berry | Hypersensitivity Berry | Intolerance Berry product | Hypersensitivity Berry product
Item
history of intolerance (including hypersensitivity or allergy) to berry or berry-containing products
boolean
C0231199 (UMLS CUI [1,1])
C0005135 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0005135 (UMLS CUI [2,2])
C0231199 (UMLS CUI [3,1])
C0005135 (UMLS CUI [3,2])
C1514468 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0005135 (UMLS CUI [4,2])
C1514468 (UMLS CUI [4,3])
Lacking Able to swallow food Orally | Lacking Able to swallow fluid Orally | Aspiration Pneumonia
Item
inability to take oral nutrition/liquids or history of aspiration pneumonia
boolean
C0332268 (UMLS CUI [1,1])
C0566359 (UMLS CUI [1,2])
C0442027 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0566364 (UMLS CUI [2,2])
C0442027 (UMLS CUI [2,3])
C0032290 (UMLS CUI [3])
Pregnancy | Black raspberry Adverse effects Unknown | Lyophilized Black Raspberry Lozenge To be stopped
Item
pregnant women: although there are no known adverse effects of black raspberries upon the fetus, if patients become pregnant during period of lyophilized black raspberries (lbr) administration, then lbr will be discontinued and patient will be removed from the study; we should however emphasize, given this is a food based-study, that risks are likely extremely low even though a participant should become pregnant; as such, we are not recommending active contraception for women, but rather if participants become pregnant, that they notify their study doctor, and that they will likely be removed from study; there are no expected or logical risks if men were to father a child, and as such, no contraception will be recommended for men
boolean
C0032961 (UMLS CUI [1])
C1031004 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C0439673 (UMLS CUI [2,3])
C3274577 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
Informed Consent Unable
Item
inability to grant informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Strict vegetarian
Item
strict vegetarians will be excluded from the study; it was found that consuming one portion per day of fruit or vegetables resulted in a significant decrease in oral cancer incidence; in those persons consuming multiple portions each day, there was a 50% reduction in risk; we assume that strict vegetarians will consume multiple portions each day of foods with chemopreventive activity and therefore inclusion of these individuals would have a negative impact on the study; there are several reports in the literature that herbal or multivitamin/mineral supplements have no effect on oral cancer incidence
boolean
C3241968 (UMLS CUI [1])
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