Breast Cancer SurvivorsEarly Phase 1NCT02062255
Impact of COX2 on Sera Biomarkers From Obese Subjects
A Early Phase 1 study testing Aspirin and Omega 3 FFA in people with Breast Cancer Survivors, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Obesity promotes worse outcome for post-menopausal breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Aspirin and Omega 3 FFA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Apr 2016
- Phase
- Early Phase 1
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Post-menopausal as confirmed by medical history
- 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
Who cannot join
- Evidence of active cancer (patients with a prior history of malignancy are encouraged to participate, but due to cytokine levels associated with malignancy there must be no evidence of disease)
- Cachexia
- Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
- Chronic use of aspirin of omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
- Known hypersensitivity to aspirin and/or omega-3 fatty acids
- Actively receiving a physician-directed regimen of aspirin and/or receiving herapeutic/prophylactic anticoagulation
Show all 9Show fewer
- Any aspirin or omega-3 free fatty acid supplementation within the last 14 days
- Subjects who are pregnant
- History of medical noncompliance
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, 78229
About this study
Official title: A Phase 0, Investigator Initiated Study, Evaluating the Impact of COX2 Inhibition on Human Sera Biomarkers From Obese Subjects
Obesity promotes worse outcome for post-menopausal breast cancer patients.
- Conditions
- Breast Cancer Survivors
- Being tested
- Aspirin, Omega 3 FFA
- Keywords
- Asprin, Omega-3 Free Fatty Acids, Obesity, COX-2 inhibitor
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Omega 3 FFADietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Twenty eight enteric coated 81mg Aspirin tablets will be dispensed for daily oral dosing, to be taken with a meal at the same time of day. Receives: Drug: Aspirin |
| Omega-3 Free Fatty Acids | Active comparator | Three hundred thirty-six gelatin coated 450 mg capsules containing approximately 180 mg of EPA and 135 mg of DHA will be dispensed. Patients are to take 12 capsules daily with meals, either once daily (12 capsules with one meal) or divided twice daily (e.g., six with breakfast and six with dinner). Receives: Dietary Supplement: Omega 3 FFA |
| Aspirin & Omega-3 FFAs | Active comparator | Aspirin (81 mg po daily) to be taken simultaneously with Omega-3 Free Fatty Acids (1500mg of docosahexaoic acid (DHA) and 2500mg eicosapentanoic acid (EPA) given daily. Receives: Drug: Aspirin; Dietary Supplement: Omega 3 FFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker levels
Blood levels of Prostaglandin E2, aromatase, pro-inflammatory cytokines, steroids, and lipids will be measured pre and post treatment.
Measured: 29 days
Secondary outcomes (1)
BMI
Correlation for body mass index impact on response to COX2 inhibition.
Measured: 29 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Brenner, The University of Texas Health Science Center at San Antonio
- Investigators
- Andrew Brenner, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062255
- Sponsor's protocol ID
- CTRC 13-0041
- Other IDs
- HSC20130426H
- Status last verified
- Oct 2016
- First submitted
- 9 Dec 2013
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. 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 COX2 Inhibition on Human Sera Biomarkers From Obese Subjects
- ClinicalTrials.gov ID
- NCT02062255
- Acronym / sponsor ID
- CTRC 13-0041
- Conditions
- Breast Cancer Survivors
- Keywords
- Asprin, Omega-3 Free Fatty Acids, Obesity, COX-2 inhibitor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Feb 2014 (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.
Obesity promotes worse outcome for post-menopausal breast cancer patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: AspirinTwenty eight enteric coated 81mg Aspirin tablets will be dispensed for daily oral dosing, to be taken with a meal at the same time of day. |
| Omega-3 Free Fatty Acids | Active comparator | Dietary Supplement: Omega 3 FFAThree hundred thirty-six gelatin coated 450 mg capsules containing approximately 180 mg of EPA and 135 mg of DHA will be dispensed. Patients are to take 12 capsules daily with meals, either once daily (12 capsules with one meal) or divided twice daily (e.g., six with breakfast and six with dinner). |
| Aspirin & Omega-3 FFAs | Active comparator | Drug: Aspirin, Dietary Supplement: Omega 3 FFAAspirin (81 mg po daily) to be taken simultaneously with Omega-3 Free Fatty Acids (1500mg of docosahexaoic acid (DHA) and 2500mg eicosapentanoic acid (EPA) given daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Post-menopausal as confirmed by medical history
- 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
Key exclusion criteria (9 listed)
- Evidence of active cancer (patients with a prior history of malignancy are encouraged to participate, but due to cytokine levels associated with malignancy there must be no evidence of disease)
- Cachexia
- Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
- Chronic use of aspirin of omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
- Known hypersensitivity to aspirin and/or omega-3 fatty acids
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 |
|---|---|---|
| Aspirin | Drug | Aspirin, Aspirin & Omega-3 FFAs |
| Omega 3 FFA | Dietary supplement | Aspirin & Omega-3 FFAs, Omega-3 Free Fatty Acids |
Primary outcome
Biomarker levels
Time frame: 29 days
Blood levels of Prostaglandin E2, aromatase, pro-inflammatory cytokines, steroids, and lipids will be measured pre and post treatment.
1 secondary outcome
BMI
Time frame: 29 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 26 Oct 2016.
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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.
Andrew Brenner, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aspirin and Omega 3 FFA in people with Breast Cancer Survivors, 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 3 inclusion and 9 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 26 Oct 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Biomarker levels (time frame: 29 days). 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 26 Oct 2016.