Breast adenocarcinoma Ductal Infiltrating TNM Breast tumor staging | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure
Item
diagnosis, within the previous 12 months with stage i-iii, infiltrating ductal adenocarcinoma of the breast who have undergone surgery and chemotherapy and are able to begin study treatment within 5 days after the last dose of radiotherapy
boolean
C0858252 (UMLS CUI [1,1])
C1512083 (UMLS CUI [1,2])
C0332448 (UMLS CUI [1,3])
C0474926 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Estrogen receptor negative | progesterone receptor negative | Estrogen receptor positive | progesterone receptor positive
Item
estrogen and/or progesterone receptor-negative or positive
boolean
C0279756 (UMLS CUI [1])
C0279766 (UMLS CUI [2])
C0279754 (UMLS CUI [3])
C0279759 (UMLS CUI [4])
Diet Willing | Avoidance Mushroom - dietary
Item
willing to eat consistent diet throughout the study, and avoid dietary sources of mushrooms
boolean
C0012159 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C0678206 (UMLS CUI [2,2])
Avoidance Preparations Containing Trametes versicolor | Avoidance Mushroom Preparations Immunomodulatory | Avoidance Plant Preparations Immunomodulatory
Item
willing to avoid taking any product containing trametes versicolor, other immune modulating medicinal mushrooms, or other herbal products believed to have immune modulating effects, during radiotherapy and until completion of the subject's last clinic visit on the study.
boolean
C0870186 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0319805 (UMLS CUI [1,4])
C0870186 (UMLS CUI [2,1])
C0001774 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C1963758 (UMLS CUI [2,4])
C0870186 (UMLS CUI [3,1])
C0949854 (UMLS CUI [3,2])
C1963758 (UMLS CUI [3,3])
Organ function
Item
adequate organ function within 14 days of study enrollment including the following:
boolean
C0678852 (UMLS CUI [1])
Mature Neutrophils Present Bone Marrow Complete | White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement
Item
adequate bone marrow reserve: white blood cells (wbc) ≥ 2,000/mm³, platelet count ≥ 100,000/mm³, hemoglobin ≥ 9 g/dl
boolean
C1708947 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement
Item
hepatic: bilirubin ≤ 20% times upper limit of normal (uln), alkaline phosphatase
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
≤ 20% times uln, ast and alt ≤ 20% times uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Renal function | Creatinine measurement, serum
Item
renal: creatinine ≤ 20% times uln
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Nutritional status | Albumin measurement
Item
nutritional status: albumin ≥ 3.0 g/dl
boolean
C0392209 (UMLS CUI [1])
C0201838 (UMLS CUI [2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Informed Consent
Item
voluntary written consent before performance of any study-related procedure not part of the normal medical care
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods | Exception Hormonal contraception
Item
pregnant - patients with reproductive potential must use an approved non-hormonal contraceptive method if appropriate during and for 4 weeks after the last dose of trametes versicolor.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2985296 (UMLS CUI [3,2])
Allergy to fungus | Hypersensitivity Mushrooms
Item
known allergy to fungi, including mushrooms
boolean
C3875242 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0001774 (UMLS CUI [2,2])
Disease serious compromises Patient safety | Mental disorders serious compromise Patient safety | Disease serious compromises Completion of clinical trial | Mental disorders serious compromise Completion of clinical trial | Communicable Disease | Diabetic - poor control
Item
serious concurrent medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C2732579 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C2732579 (UMLS CUI [4,4])
C0009450 (UMLS CUI [5])
C0421258 (UMLS CUI [6])
Hematopoietic Growth Factors | Neupogen | Epogen
Item
receipt of hematopoietic growth factors (e.g., neupogen™, epogen™) within the previous 4 weeks
boolean
C0079490 (UMLS CUI [1])
C0733468 (UMLS CUI [2])
C0700704 (UMLS CUI [3])
Complementary and alternative medicine Maintenance Unwilling | Complementary and alternative medicine Dosage Maintenance Unwilling
Item
unwilling to maintain consistency in type and dose of concurrent complementary and alternative medicine therapies
boolean
C1148475 (UMLS CUI [1,1])
C0024501 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C1148475 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0024501 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Pharmaceutical Preparations Excluded Discontinue Unwilling | Supplement Excluded Discontinue Unwilling
Item
unwilling to discontinue excluded medications and supplements
boolean
C0013227 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
C2348609 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])