ClinicalTrials.gov
ClinicalTrials.gov Menu

Antioxidant Supplements, Genetics and Chemotherapy Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03413761
Recruitment Status : Completed
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease
Node Positive Breast Cancer Node Negative 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
Actual Enrollment : 1771 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antioxidant Supplements, Genetics and Chemotherapy Outcomes
Actual Study Start Date : December 18, 2004
Actual Primary Completion Date : November 12, 2013
Actual Study Completion Date : November 12, 2013

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Epidemiologic Questionnaire [ Time Frame: At baseline interview ]
    Self administered questionnaire to evaluate use of antioxidant supplements in relation to toxicity

  2. Evaluate if variants in genes are associate with treatment related toxicities [ Time Frame: Prior to treatment ]
    Polymorphisms will be determined by sequencing as described in detail on the National Cancer Institute'sSNP500Cancer database

  3. Evaluate if variants in genes are associate with treatment related toxicities [ Time Frame: Year 5 ]
    Polymorphisms will be determined by sequencing as described in detail on the National Cancer Institute'sSNP500Cancer database

  4. Epidemiologic Questionnaire [ Time Frame: every 6 months for 5 years ]
    Self administered questionnaire to evaluate use of antioxidant supplements in relation to disease free survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Woman from SWOG trial S0221 with node-positive or high-risk node-negative breast cancer.
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)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03413761     History of Changes
Other Study ID Numbers: EPR 43304
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs