Breastcancer
Conditions
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTOmega-3 FFA
Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in circulating levels of eicosanoids. | 30 days |
| Change in circulating levels of metabolics. | 30 days |
| Change in serum colony stimulating factor at surgery | 30 days |
| Change in circulating levels of pro-inflammatory cytokines. | 30 days |
Countries
United States
Outcome results
None listed