Clinical trial NCT03413761: Antioxidant Supplements, Genetics and Chemotherapy Outcomes
Official title: Antioxidant Supplements, Genetics and Chemotherapy Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Node Positive Breast Cancer
Node Negative Breast Cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 1771
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Woman from SWOG trial S0221 with node-positive or high-risk node-negative breast cancer.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Epidemiologic Questionnaire
timeFrame: At baseline interview
measure: Evaluate if variants in genes are associate with treatment related toxicities
timeFrame: Prior to treatment
measure: Evaluate if variants in genes are associate with treatment related toxicities
timeFrame: Year 5
measure: Epidemiologic Questionnaire
timeFrame: every 6 months for 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.