Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT00680667
Eligibility Criteria:
Inclusion Criteria:
* 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
* Estrogen and/or progesterone receptor-negative or positive
* Willing to eat consistent diet throughout the study, and avoid dietary sources of mushrooms
* 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.
* Adequate organ function within 14 days of study enrollment including the following:
* Adequate bone marrow reserve: White blood cells (WBC) ≥ 2,000/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin ≥ 9 g/dL
* Hepatic: Bilirubin ≤ 20% times upper limit of normal (ULN), Alkaline phosphatase ≤ 20% times ULN, AST and ALT ≤ 20% times ULN
* Renal: Creatinine ≤ 20% times ULN
* Nutritional status: Albumin ≥ 3.0 g/dL
* Negative pregnancy test
* Voluntary written consent before performance of any study-related procedure not part of the normal medical care
Exclusion Criteria:
* 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.
* Known allergy to fungi, including mushrooms
* 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
* Receipt of hematopoietic growth factors (e.g., Neupogen™, Epogen™) within the previous 4 weeks
* Unwilling to maintain consistency in type and dose of concurrent complementary and alternative medicine therapies
* Unwilling to discontinue excluded medications and supplements
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT00680667
Study Brief:
Protocol Section:
NCT00680667