BreastcancerNCT02996240
Breast, Omega 3 Free Fatty Acid, Ph 0
A study testing Omega-3 FFA in people with Breastcancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Assess the impact of dietary omega 3 free fatty acids breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breastcancer
- What is being tested?
- Omega-3 FFA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2017to 22 Feb 2021
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- ECOG ≤2
- Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
- Consented for tissue collection on CTRC repository 07-32
Who cannot join
- Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
- Chronic use of NSAIDs or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
- Any NSAIDs or omega-3 free fatty acid supplementation within the last 14 days
- History of medical noncompliance
- Scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days
Trial locations and contacts
1 site in 1 country.
United States1 site
CTRC at University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Free Fatty Acid Supplementation on Breast Cancer (CTMS# 16-0119)
Assess the impact of dietary omega 3 free fatty acids breast cancer patients.
Read the detailed description
Prospective, single arm, short term study with correlative biomarker endpoints. Two hundred (200) newly diagnosed breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection. Patients will be receive fish Oil (Omega-3 FFAs, 2700 mg by mouth twice daily).
- Conditions
- Breastcancer
- Being tested
- Omega-3 FFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 FFADietary supplement
Also called Omacor
Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 FFA | Experimental | Patients will take 12 capsules daily with meals, divided twice daily (example, 6 with breakfast and 6 with dinner). Receives: Dietary Supplement: Omega-3 FFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum colony stimulating factor at surgery
Measured: 30 days
Change in circulating levels of pro-inflammatory cytokines.
Measured: 30 days
Change in circulating levels of eicosanoids.
Measured: 30 days
Change in circulating levels of metabolics.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start12 Jun 2017
- Primary completion27 Sep 2019
- Study completion22 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastcancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia G. Kaklamani, The University of Texas Health Science Center at San Antonio
- Investigators
- Virginia G Kaklamani, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996240
- Sponsor's protocol ID
- CTMS 16-0119
- Other IDs
- 16-665H
- Status last verified
- Mar 2021
- First submitted
- 12 Dec 2016
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Free Fatty Acid Supplementation on Breast Cancer (CTMS# 16-0119)
- ClinicalTrials.gov ID
- NCT02996240
- Acronym / sponsor ID
- CTMS 16-0119
- Conditions
- Breastcancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 19 Dec 2016 (estimated)
- 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.
Assess the impact of dietary omega 3 free fatty acids breast cancer patients.
Detailed description
Prospective, single arm, short term study with correlative biomarker endpoints. Two hundred (200) newly diagnosed breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection. Patients will be receive fish Oil (Omega-3 FFAs, 2700 mg by mouth twice daily).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega-3 FFA | Experimental | Dietary Supplement: Omega-3 FFAPatients will take 12 capsules daily with meals, divided twice daily (example, 6 with breakfast and 6 with dinner). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- ECOG ≤2
- Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
- Consented for tissue collection on CTRC repository 07-32
Key exclusion criteria (5 listed)
- Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
- Chronic use of NSAIDs or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
- Any NSAIDs or omega-3 free fatty acid supplementation within the last 14 days
- History of medical noncompliance
- Scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 FFAAlso: OmacorOmega-3 Free Fatty Acid will be given as a fish oil in a capsule. | Dietary supplement | Omega-3 FFA |
Primary outcome
Change in serum colony stimulating factor at surgery
Time frame: 30 days
Change in circulating levels of pro-inflammatory cytokines.
Time frame: 30 days
Change in circulating levels of eicosanoids.
Time frame: 30 days
Change in circulating levels of metabolics.
Time frame: 30 days
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 17 Mar 2021.
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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.
Virginia G Kaklamani, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 FFA in people with Breastcancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 4 inclusion and 5 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in serum colony stimulating factor at surgery (time frame: 30 days). 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?
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 17 Mar 2021.