Node Positive Breast CancerNCT03413761
Antioxidant Supplements, Genetics and Chemotherapy Outcomes
An observational study of Node Positive Breast Cancer and Node Negative Breast Cancer, run by Roswell Park Cancer Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Node Positive Breast Cancer, Node Negative Breast Cancer
- How many people
- 1,771 participants
- Where
- No sites listed yet
- Study dates
- 18 Dec 2004to 12 Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Woman from SWOG trial S0221 with node-positive or high-risk node-negative breast cancer.
Who may be able to join
- 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
Show all 13Show fewer
- 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)
Who cannot join
None listed.
About this study
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.
Read the 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:
- 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.
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiologic Questionnaire
Self administered questionnaire to evaluate use of antioxidant supplements in relation to toxicity
Measured: 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
Measured: 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
Measured: Year 5
Epidemiologic Questionnaire
Self administered questionnaire to evaluate use of antioxidant supplements in relation to disease free survival
Measured: every 6 months for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start18 Dec 2004
- Primary completion12 Nov 2013
- Study completion12 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Node Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413761
- Sponsor's protocol ID
- EPR 43304
- Status last verified
- Aug 2022
- First submitted
- 5 Jan 2018
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30486865
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant Supplements, Genetics and Chemotherapy Outcomes
- ClinicalTrials.gov ID
- NCT03413761
- Acronym / sponsor ID
- EPR 43304
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,771 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 18 Dec 2004 (actual)
- Primary completion
- 12 Nov 2013 (actual)
- Study completion
- 12 Nov 2013 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Woman from SWOG trial S0221 with node-positive or high-risk node-negative breast cancer.
Key inclusion criteria (13 listed)
- 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:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiologic Questionnaire
Time frame: At baseline interview
Self administered questionnaire to evaluate use of antioxidant supplements in relation to toxicity
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Derived from this study: PubMed 30486865Mongiovi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Node Positive Breast Cancer and Node Negative Breast Cancer, run by Roswell Park Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiologic Questionnaire (time frame: At baseline interview). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03413761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.