Breast CancerEarly Phase 1NCT02538484
Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects
A Early Phase 1 study testing Letrozole and Fish Oil in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Letrozole and Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to 26 Mar 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Postmenopausal as confirmed in 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 (Institutional Review Board)/Ethics Committee.
- Estrogen receptor positive breast cancer. Body mass index of 30 or greater.
- Consented for tissue collection on CTRC (Cancer Therapy and Research Center) repository 07-32
Who cannot join
- Cachexia
- Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
- Chronic use of NSAIDs (nonsteroidal anti-inflammatory drugs) aspirin or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
- Any NSAIDs aspirin 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
2 sites in 1 country.
United States2 sites
Houston Methodist Cancer Center at Texas Medical Center
Houston, Texas, 77030
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.
Read the detailed description
Prospective, comparative, three arm, short term, non-interventional study with correlative biomarker endpoints. Sixty (60) obese (≥ 30 BMI) newly diagnosed ER+ postmenopausal breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection.
- Conditions
- Breast Cancer
- Being tested
- Letrozole, Fish Oil
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara
Aromatase inhibitor
Fish OilDietary supplement
Also called Omega-3
Omega-3 free fatty acid
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Active comparator | Letrozole 2.5 mg by mouth daily for 30 days. Receives: Drug: Letrozole |
| Fish Oil | Active comparator | Fish oil 2700 mg by mouth daily for 30 days. Receives: Dietary Supplement: Fish Oil |
| Letrozole and Fish Oil | Active comparator | Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days. Receives: Drug: Letrozole; Dietary Supplement: Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of aromatase target gene.
Measured: 30 Days
Change in serum levels of PGE2 (prostaglandin E2).
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 posted2 Sep 2015 (estimated)
- Study startApr 2016
- Primary completion11 Mar 2020
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Brenner, MD, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538484
- Sponsor's protocol ID
- CTMS# 15-2100
- Other IDs
- HSC20150602H
- Status last verified
- Jul 2023
- First submitted
- 11 Aug 2015
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. 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 Fatty Acid Supplementation on Aromatase in Obese Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT02538484
- Acronym / sponsor ID
- CTMS# 15-2100
- Conditions
- Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 2 Sep 2015 (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 and/or letrozole on obese, postmenopausal breast cancer patients.
Detailed description
Prospective, comparative, three arm, short term, non-interventional study with correlative biomarker endpoints. Sixty (60) obese (≥ 30 BMI) newly diagnosed ER+ postmenopausal breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Active comparator | Drug: LetrozoleLetrozole 2.5 mg by mouth daily for 30 days. |
| Fish Oil | Active comparator | Dietary Supplement: Fish OilFish oil 2700 mg by mouth daily for 30 days. |
| Letrozole and Fish Oil | Active comparator | Drug: Letrozole, Dietary Supplement: Fish OilLetrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age.
- Postmenopausal as confirmed in 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 (Institutional Review Board)/Ethics Committee.
- Estrogen receptor positive breast cancer. Body mass index of 30 or greater.
- Consented for tissue collection on CTRC (Cancer Therapy and Research Center) repository 07-32
Key exclusion criteria (6 listed)
- Cachexia
- Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
- Chronic use of NSAIDs (nonsteroidal anti-inflammatory drugs) aspirin or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
- Any NSAIDs aspirin or omega-3 free fatty acid supplementation within the last 14 days
- History of medical noncompliance
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 |
|---|---|---|
| LetrozoleAlso: FemaraAromatase inhibitor | Drug | Letrozole, Letrozole and Fish Oil |
| Fish OilAlso: Omega-3Omega-3 free fatty acid | Dietary supplement | Fish Oil, Letrozole and Fish Oil |
Primary outcome
Change in levels of aromatase target gene.
Time frame: 30 Days
Change in serum levels of PGE2 (prostaglandin E2).
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 Jul 2023.
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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, PhD principal investigator
Principal Investigator
2 sites 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 Letrozole and Fish Oil in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 2 sites 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 5 inclusion and 6 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 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in levels of aromatase target gene. (time frame: 30 Days). The study lists 2 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 Jul 2023.