Antioxidant Supplements, Genetics and Chemotherapy Outcomes

NCT03413761 | Completed

• 1 other identifier: EPR 43304
• Study Type: observational
• Target: 1,771
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Node Positive Breast Cancer; Node Negative Breast Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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:
• tumor \>= 2 cm in greatest diameter
• 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)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Related Publications (1)

• 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.

  PMID: 30486865 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 29, 2018
• Study Start: December 18, 2004
• Primary Completion: November 12, 2013
• Study Completion: November 12, 2013
• Last Updated: August 8, 2022

Record last verified: 2022-08