Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2026-01-05 @ 6:19 AM
Study NCT ID:
NCT03413761
Status:
COMPLETED
Last Update Posted:
2022-08-08
First Post:
2018-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antioxidant Supplements, Genetics and Chemotherapy Outcomes
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
Antioxidant Supplements, Genetics and Chemotherapy Outcomes
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: