Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-24 @ 1:09 PM
NCT ID:
NCT03413761
Brief Summary:
This study will investigate the null hypothesis that use of antioxidant supplements during adjuvant chemotherapy will have no impact on toxicities and disease-free, as well as overall, survival, and also evaluate the role of polymorphisms in genes related to oxidative stress in relation to treatment outcomes.
Detailed Description:
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.
Study:
NCT03413761
Study Brief:
Protocol Section:
NCT03413761