Antioxidant Supplements, Genetics and Chemotherapy Outcomes
Słowa kluczowe
Abstrakcyjny
Opis
This study will enroll 3000 women from S0221with node positive or high-risk node-negative breast cancer receiving AC+T onto this ancillary study to address the following specific aims:
1. To characterize use of antioxidant supplements with a survey instrument prior to and at completion of treatment, and to evaluate reported use pre and post treatment in relation to toxicity and disease-free survival. The potential effects of diet, physical activity, and other lifestyle factors on relationships between supplement use and treatment outcomes will also be considered.
2. To evaluate if variants (polymorphisms) in genes that produce reactive oxygen species (ROS) (MPO) and in genes that protect cells from the effects of ROS are associated with treatment-related toxicities and with disease-free survival.
Daktyle
| Ostatnia weryfikacja: | 12/31/2017 |
| Pierwsze przesłane: | 01/04/2018 |
| Szacowana liczba przesłanych rejestracji: | 01/25/2018 |
| Wysłany pierwszy: | 01/28/2018 |
| Ostatnia aktualizacja przesłana: | 01/25/2018 |
| Ostatnia opublikowana aktualizacja: | 01/28/2018 |
| Rzeczywista data rozpoczęcia badania: | 12/17/2004 |
| Szacowana data zakończenia podstawowej działalności: | 11/11/2013 |
| Szacowana data zakończenia badania: | 11/11/2013 |
Stan lub choroba
Faza
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
| Płeć kwalifikująca się do nauki | All |
| Metoda próbkowania | Probability Sample |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | Inclusion Criteria: - Histologically confirmed diagnosis of operable Stage 1, II, or III invasive breast cancer with known estrogen or progesterone receptor status - high risk by meeting at least one of the following criteria: 1. tumor >= 2 cm in greatest diameter 2. one or more axillary or intramammary nodes are involved by metastatic breast cancer - had either a modified radical mastectomy or local excision of all tumors plus axillary node dissection or sentinel node resection - not received prior chemotherapy or radiation therapy for the current malignancy - no history of congestive heart failure or angina pectoris - normal creatinine and bilirubin, alkaline phosphatase and SGOT or SGPT 2 x the institutional upper limits of normal - ANC greater than or equal to 1,200 ul and platelet count of greater than or equal 100,000 U1 - No previous malignancies - Age 18 or greater - Performance status of 0 -2 by Zubrod criteria - HIV negative (if known) |
Wynik
Podstawowe miary wyników
1. Epidemiologic Questionnaire [At baseline interview]
2. Evaluate if variants in genes are associate with treatment related toxicities [Prior to treatment]
3. Evaluate if variants in genes are associate with treatment related toxicities [Year 5]
4. Epidemiologic Questionnaire [every 6 months for 5 years]
