Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women

A Pilot Study: Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women

The study plans to find out whether Celebrex may be potentially useful to decrease inflammation in fat tissues and thereby lower the production of substances such as estrogens that may increase the risk of developing breast cancer and lead to a poor outcome of the disease.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Celebrex

Detailed Description

This study seeks to examine how effective the celebrex may be in reducing inflammation, crown-like structures in fat tissue, the enzyme aromatase, PGE-M in the urine and estrogen in blood and urine. Volunteer subjects will be expected to stay in the hospital for about 2 weeks taking Celebrex for approximately 10 days while eating a diet similar to what they consumed before coming into the hospital for the study.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • The Rockefeller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Postmenopausal woman defined as: 24 consecutive months without a menstrual period and currently not taking any medication known to induce amenorrhea.
• Serum estradiol < 20 pg/mL
• Body Mass Index of 35-50
• Stable weight defined as (+/- 5 %) of body weight for at least three months
• 40-70 years of age
• Fluent in English

Exclusion Criteria:

• Known hypersensitivity to celecoxib or sulfonamides
• Known peptic ulcer disease
• Hypertension BP > 150/90 (on 2 occasions after resting)
• Fasting blood glucose > 165 mg/dL
• HIV positive
• Screening creatinine > 2X upper limit of normal
• Screening LFT results > 2x upper limit of normal
• Smokers (or stopped < 3 months ago)
• Framingham risk score > 15
• Evidence of active coronary disease by history and/or EKG
• Subjects who consume 25 grams of soy protein/day or more than 45 mg of isoflavones/day, for subjects who consume this amount of soy, they may stop for 14 days prior to admission
• Currently taking NSAIDS, aspirin, (if > once a week, stopped <30 days ago).
• Consuming > 3 servings of fish or seafood/week
• Currently taking fish oil, omega-3 supplements or other herbal supplements that exceed GRAS (Generally Recognized as Safe) levels, (if currently taking fish oil/omega-3 supplements, there must be a 30 day washout period)
• Current use of anti-coagulants
• Currently taking any weight control medication
• Currently taking thioridazine
• Currently taking lithium
• Currently taking any estrogen/progesterone hormones including vaginal cream, e-string, or vaginal tablets
• Currently taking any medication that can alter fat stores as determined by the principal investigator
• History of Inflammatory Bowel Disease or other chronic inflammatory disorders
• History of any malignancy other than non-melanoma skin cancer in the past 5 years
• History of any bleeding disorder
• History of cardiovascular disease
• Diagnosis of asthma
• Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Celebrex; 10 days treatment with Celebrex to evaluate reduction of PGE-M in urine	Drug: Celebrex; 200 mg PO BID; Other Names: Celecoxib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine	Study endpoint is a reduction in PGE-M in urine after treatment with celebrex	10 days

Collaborators and Investigators

• Sponsor: Rockefeller University
• Investigators: Principal Investigator: Peter Holt, MD, Rockefeller University

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Post-menopausal
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: PHO-0807

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No