Antioxidant Supplements, Genetics and Chemotherapy Outcomes

Completed

• Conditions: Node Positive Breast Cancer; Node Negative Breast Cancer

• Registration Number: NCT03413761
• Lead Sponsor: Roswell Park Cancer Institute

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 Timeline

• Study Start: 2004-12-18
• Primary Completion: 2013-11-12
• Study Completion: 2013-11-12
• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-01-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1771

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epidemiologic Questionnaire	every 6 months for 5 years	Self administered questionnaire to evaluate use of antioxidant supplements in relation to disease free survival
Evaluate if variants in genes are associate with treatment related toxicities	Year 5	Polymorphisms will be determined by sequencing as described in detail on the National Cancer Institute'sSNP500Cancer database