Antioxidant Supplements, Genetics and Chemotherapy Outcomes

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 1771

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Woman from SWOG trial S0221 with node-positive or high-risk node-negative breast cancer.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute

Publications and helpful links

General Publications

• Mongiovi JM, Zirpoli GR, Cannioto R, Sucheston-Campbell LE, Hershman DL, Unger JM, Moore HCF, Stewart JA, Isaacs C, Hobday TJ, Salim M, Hortobagyi GN, Gralow JR, Thomas Budd G, Albain KS, Ambrosone CB, McCann SE. Associations between self-reported diet during treatment and chemotherapy-induced peripheral neuropathy in a cooperative group trial (S0221). Breast Cancer Res. 2018 Nov 28;20(1):146. doi: 10.1186/s13058-018-1077-9.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2004
• Primary Completion (Actual): November 12, 2013
• Study Completion (Actual): November 12, 2013

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: EPR 43304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No