Impact of COX2 on Sera Biomarkers From Obese Subjects

Breast Cancer Survivors Clinical Trial

Official title:

A Phase 0, Investigator Initiated Study, Evaluating the Impact of COX2 Inhibition on Human Sera Biomarkers From Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062255
• Other study ID #: CTRC 13-0041
• Secondary ID: HSC20130426H
• Status: Completed
• Phase: Phase 0
• First received: December 9, 2013
• Last updated: October 24, 2016
• Start date: October 2013
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Obesity promotes worse outcome for post-menopausal breast cancer patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Any aspirin or omega-3 free fatty acid supplementation within the last 14 days

• Subjects who are pregnant

• History of medical noncompliance

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Cancer Survivors

Intervention

Drug:
• Aspirin

Dietary Supplement:
• Omega 3 FFA

Locations

Country	Name	City	State
United States	Cancer Therapy and Research Center at UTHSCSA	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker levels	Blood levels of Prostaglandin E2, aromatase, pro-inflammatory cytokines, steroids, and lipids will be measured pre and post treatment.	29 days	No
Secondary	BMI	Correlation for body mass index impact on response to COX2 inhibition.	29 Days	No