Clinical trial · Observational
Antioxidant Supplements, Genetics and Chemotherapy Outcomes
NCT03413761CI-TRIAL-00060179completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Node Negative Breast Cancer | — | UNRESOLVED | — |
| Node Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Epidemiologic Questionnaire
- timeFrame
- At baseline interview
- description
- Self administered questionnaire to evaluate use of antioxidant supplements in relation to toxicity
- measure
- Evaluate if variants in genes are associate with treatment related toxicities
- timeFrame
- Prior to treatment
- description
- Polymorphisms will be determined by sequencing as described in detail on the National Cancer Institute'sSNP500Cancer database
- measure
- Evaluate if variants in genes are associate with treatment related toxicities
- timeFrame
- Year 5
- description
- Polymorphisms will be determined by sequencing as described in detail on the National Cancer Institute'sSNP500Cancer database
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDMongiovi 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