ID

44619

Description

Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00955942

Link

https://clinicaltrials.gov/show/NCT00955942

Keywords

Versions (2)
  1. 8/5/17 8/5/17 -
  2. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00955942

English

Eligibility Lung Cancer NCT00955942

1 forms  
Criteria
Description

Criteria

diagnosis of non-small cell lung cancer
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
locally advanced or metastatic disease
Description

Neoplasm Metastasis Advanced Locally

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
requires definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy
Description

Radiotherapy to thorax Definitive Patient need for | Radiotherapy to mediastinum Definitive Patient need for | Chemotherapy Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C4038705
UMLS CUI [1,2]
C0443196
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C4049191
UMLS CUI [2,2]
C0443196
UMLS CUI [2,3]
C0686904
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0686904
total planned radiation dose to gross disease 60-80 gy
Description

Radiotherapy Dose Planned Disease Gross

Data type

boolean

Alias
UMLS CUI [1,1]
C0034620
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0439806
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
no diagnosis of disease of the gastrointestinal (gi) system, liver, or kidneys that could result in altered metabolism or excretion of the study medication (e.g., history of major gi tract surgery, gastrectomy, gastrostomy, or bowel resection)
Description

Exclusion Criteria | Gastrointestinal Diseases Resulting in Metabolism altered | Liver diseases Resulting in Metabolism altered | Kidney Diseases Resulting in Metabolism altered | Gastrointestinal Diseases Resulting in Excretion Investigational New Drugs | Liver diseases Resulting in Excretion Investigational New Drugs | Kidney Diseases Resulting in Excretion Investigational New Drugs | Operation on gastrointestinal tract Major | Gastrectomy | Gastrostomy | Bowel resection

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0025519
UMLS CUI [2,4]
C0392747
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0332294
UMLS CUI [3,3]
C0025519
UMLS CUI [3,4]
C0392747
UMLS CUI [4,1]
C0022658
UMLS CUI [4,2]
C0332294
UMLS CUI [4,3]
C0025519
UMLS CUI [4,4]
C0392747
UMLS CUI [5,1]
C0017178
UMLS CUI [5,2]
C0332294
UMLS CUI [5,3]
C0221102
UMLS CUI [5,4]
C0013230
UMLS CUI [6,1]
C0023895
UMLS CUI [6,2]
C0332294
UMLS CUI [6,3]
C0221102
UMLS CUI [6,4]
C0013230
UMLS CUI [7,1]
C0022658
UMLS CUI [7,2]
C0332294
UMLS CUI [7,3]
C0221102
UMLS CUI [7,4]
C0013230
UMLS CUI [8,1]
C0399610
UMLS CUI [8,2]
C0205164
UMLS CUI [9]
C0017118
UMLS CUI [10]
C0017196
UMLS CUI [11]
C0741614
no history of chronic gi disorders (e.g., ulcerative colitis, regional enteritis, or gi bleeding)
Description

Exclusion Criteria | Gastrointestinal Diseases | Ulcerative Colitis | Regional enteritis | Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0009324
UMLS CUI [4]
C0678202
UMLS CUI [5]
C0017181
no known hypersensitivity to flaxseed or any of its metabolites or to wheat products
Description

Exclusion Criteria | Hypersensitivity Flaxseed | Hypersensitivity Flaxseed Metabolite | Hypersensitivity Wheat product

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0023753
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0023753
UMLS CUI [3,3]
C0870883
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0043137
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.10

Data type

boolean

see patient characteristics
Description

ID.11

Data type

boolean

more than 14 days since prior and no concurrent investigational drugs
Description

Investigational New Drugs Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C2828389
more than 14 days since prior and no concurrent amifostine or mucomyst (n-acetylcysteine)
Description

Exclusion Criteria | Amifostine | Mucomyst | Acetylcysteine

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0015020
UMLS CUI [3]
C0699252
UMLS CUI [4]
C0001047
no prior thoracic radiotherapy
Description

Radiotherapy to thorax Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C4038705
UMLS CUI [1,2]
C2828389
no prior or other concurrent flaxseed, flax-containing products, soybeans, or soy-containing products
Description

Exclusion Criteria | Flaxseed | Products Containing Flax | Soybeans | Products Containing Soy

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0023753
UMLS CUI [3,1]
C1514468
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0023753
UMLS CUI [4]
C0037733
UMLS CUI [5,1]
C1514468
UMLS CUI [5,2]
C0332256
UMLS CUI [5,3]
C2756587
no other concurrent dietary supplements, such as herbals or botanicals
Description

Exclusion Criteria | Dietary Supplements | Herbal Preparations | Botanicals

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0242295
UMLS CUI [3]
C0949854
UMLS CUI [4]
C1456557
vitamins or multivitamins, including calcium and vitamin d, are allowed
Description

Vitamins | Multivitamins | Calcium | Vitamin D

Data type

boolean

Alias
UMLS CUI [1]
C0042890
UMLS CUI [2]
C0301532
UMLS CUI [3]
C0006675
UMLS CUI [4]
C0042866
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Similar models

Eligibility Lung Cancer NCT00955942

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-Small Cell Lung Carcinoma
Item
diagnosis of non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Neoplasm Metastasis Advanced Locally
Item
locally advanced or metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
Radiotherapy to thorax Definitive Patient need for | Radiotherapy to mediastinum Definitive Patient need for | Chemotherapy Patient need for
Item
requires definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy
boolean
C4038705 (UMLS CUI [1,1])
C0443196 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C4049191 (UMLS CUI [2,1])
C0443196 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Radiotherapy Dose Planned Disease Gross
Item
total planned radiation dose to gross disease 60-80 gy
boolean
C0034620 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0439806 (UMLS CUI [1,4])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Exclusion Criteria | Gastrointestinal Diseases Resulting in Metabolism altered | Liver diseases Resulting in Metabolism altered | Kidney Diseases Resulting in Metabolism altered | Gastrointestinal Diseases Resulting in Excretion Investigational New Drugs | Liver diseases Resulting in Excretion Investigational New Drugs | Kidney Diseases Resulting in Excretion Investigational New Drugs | Operation on gastrointestinal tract Major | Gastrectomy | Gastrostomy | Bowel resection
Item
no diagnosis of disease of the gastrointestinal (gi) system, liver, or kidneys that could result in altered metabolism or excretion of the study medication (e.g., history of major gi tract surgery, gastrectomy, gastrostomy, or bowel resection)
boolean
C0680251 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0025519 (UMLS CUI [2,3])
C0392747 (UMLS CUI [2,4])
C0023895 (UMLS CUI [3,1])
C0332294 (UMLS CUI [3,2])
C0025519 (UMLS CUI [3,3])
C0392747 (UMLS CUI [3,4])
C0022658 (UMLS CUI [4,1])
C0332294 (UMLS CUI [4,2])
C0025519 (UMLS CUI [4,3])
C0392747 (UMLS CUI [4,4])
C0017178 (UMLS CUI [5,1])
C0332294 (UMLS CUI [5,2])
C0221102 (UMLS CUI [5,3])
C0013230 (UMLS CUI [5,4])
C0023895 (UMLS CUI [6,1])
C0332294 (UMLS CUI [6,2])
C0221102 (UMLS CUI [6,3])
C0013230 (UMLS CUI [6,4])
C0022658 (UMLS CUI [7,1])
C0332294 (UMLS CUI [7,2])
C0221102 (UMLS CUI [7,3])
C0013230 (UMLS CUI [7,4])
C0399610 (UMLS CUI [8,1])
C0205164 (UMLS CUI [8,2])
C0017118 (UMLS CUI [9])
C0017196 (UMLS CUI [10])
C0741614 (UMLS CUI [11])
Exclusion Criteria | Gastrointestinal Diseases | Ulcerative Colitis | Regional enteritis | Gastrointestinal Hemorrhage
Item
no history of chronic gi disorders (e.g., ulcerative colitis, regional enteritis, or gi bleeding)
boolean
C0680251 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0678202 (UMLS CUI [4])
C0017181 (UMLS CUI [5])
Exclusion Criteria | Hypersensitivity Flaxseed | Hypersensitivity Flaxseed Metabolite | Hypersensitivity Wheat product
Item
no known hypersensitivity to flaxseed or any of its metabolites or to wheat products
boolean
C0680251 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0023753 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0023753 (UMLS CUI [3,2])
C0870883 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0043137 (UMLS CUI [4,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.10
Item
see disease characteristics
boolean
ID.11
Item
see patient characteristics
boolean
Investigational New Drugs Exclusion
Item
more than 14 days since prior and no concurrent investigational drugs
boolean
C0013230 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Exclusion Criteria | Amifostine | Mucomyst | Acetylcysteine
Item
more than 14 days since prior and no concurrent amifostine or mucomyst (n-acetylcysteine)
boolean
C0680251 (UMLS CUI [1])
C0015020 (UMLS CUI [2])
C0699252 (UMLS CUI [3])
C0001047 (UMLS CUI [4])
Radiotherapy to thorax Exclusion
Item
no prior thoracic radiotherapy
boolean
C4038705 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Exclusion Criteria | Flaxseed | Products Containing Flax | Soybeans | Products Containing Soy
Item
no prior or other concurrent flaxseed, flax-containing products, soybeans, or soy-containing products
boolean
C0680251 (UMLS CUI [1])
C0023753 (UMLS CUI [2])
C1514468 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0023753 (UMLS CUI [3,3])
C0037733 (UMLS CUI [4])
C1514468 (UMLS CUI [5,1])
C0332256 (UMLS CUI [5,2])
C2756587 (UMLS CUI [5,3])
Exclusion Criteria | Dietary Supplements | Herbal Preparations | Botanicals
Item
no other concurrent dietary supplements, such as herbals or botanicals
boolean
C0680251 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
C0949854 (UMLS CUI [3])
C1456557 (UMLS CUI [4])
Vitamins | Multivitamins | Calcium | Vitamin D
Item
vitamins or multivitamins, including calcium and vitamin d, are allowed
boolean
C0042890 (UMLS CUI [1])
C0301532 (UMLS CUI [2])
C0006675 (UMLS CUI [3])
C0042866 (UMLS CUI [4])
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