Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This study aims to determine if a supplement of an omega-3-fatty acid (docosahexaenoic - DHA) lowers inflammation in human fat tissue thereby lowering estrogen production and the potential risk for breast, rectal and colon cancers. The investigators also aim to study how this occurs to discover the basis for other potential treatments to lower estrogen production in fat tissue and decrease the risk of breast cancer. Additionally, this study will evaluate the effectiveness of DHA supplements in reducing inflammation and the risk for colon cancer.

Further Study Information

Breast cancer and colorectal cancer are two of the most frequently seen cancers in the United States. Breast cancer occurs at all ages but is particularly common in post menopausal women. Obesity increases the risk of breast cancer primarily of the type that is stimulated by the female sex hormone estrogen. In obesity, fat cells produce estrogen which can alter breast tissue, while lowering blood estrogen reduces the incidence of breast cancer. Inflammation of fat tissue, the coronary blood vessels and the liver are also seen with obesity. Animal experiments have shown the inflammation in fat tissue increases the production of estrogen, thus reducing inflammation in fat tissue might lower estrogen levels and the risk of breast cancer in obese women. Obesity simultaneously increases the inflammation of colon tissue. Since chronic inflammation in the colon is a co-factor in rectal and colon cancers, reducing inflammation should lower the risk of developing these cancers as well. A diet high in omega-3-fatty acids, such as those found in fish oil, has been shown in mice to reduce inflammation and aromatase expression (rate limiting enzyme for estrogen synthesis) in fat tissue and to reduce inflammation in the colon of mice and humans.

This pilot study of five obese, postmenopausal women will include nutritional and medical evaluations, a four day inpatient hospital stay on a regular diet, and to measure the inflammation and the estrogen producing machinery and resting energy of each volunteer subject, as well as, biopsies of abdominal fat tissue and the inflammation in the sigmoid colon obtained by sigmoidoscopy. Following these baseline measurements, subjects will be provided DHA supplements to take daily for three months and requested to weigh themselves twice weekly at home with the goal of maintaining their weight. Telephone interviews will be performed at scheduled points to check-in with the subjects and after six weeks blood tests will be performed. At three months each subject will be readmitted to the hospital and repeat the tests performed before starting on the DHA supplement. If the study shows feasibility and positive results it will be extended to more subjects and other interventions in the future.

Eligibility Criteria

Inclusion Criteria:

Post-menopausal defined as:

1. 24 consecutive months without a menstrual period AND

2. low serum estradiol level (<40 ng/ml) to be assessed at screening AND

3. not taking any medication known to induce ammenorhea AND

4. no known endocrine abnormality associated with irregular/absent menses.

5. BMI greater than 35.

Exclusion Criteria:

1. Currently taking any hormone therapy: oral, transplanted, vaginal, injected

2. Currently taking NSAIDS (if > once a week, stopped < 30 days ago)

3. Currently taking oral hypoglycemics

4. Currently taking anticoagulants or stopped < 30 days ago

5. Any history of a malignancy excluding basal and squamous cell skin cancer

6. Blood Pressure > 150/90 at screening

7. History of any bleeding disorder

8. LFT results > 2x normal upper limits

9. Renal lab value results > 2x normal upper limits

10. Any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could complicate the study results, or may interfere significantly with participation in the study.

11. History of intestinal malabsorption

12. RBC's (red blood cells) on screening urinalysis

13. History of chronic diarrhea

14. Using any drug study medications or multiple medications that might change the bowel lining.

15. On any medications that can alter fat stores or large bowel inflammation as deemed by the principal investigator

16. History of inflammatory bowel disease

17. Abnormal thyroid function based on screening labs

18. Currently using any weight control medication

19. HIV positive as per POCT rapid test at screening

20. Currently taking fish oil, omega-3 supplements or other herbals that exceed the GRAS (Generally Recognized As Safe)

21. Fasting blood sugar greater than 126 mg/dL at screening

22. Currently taking more than 3 antihypertensive medications

Trial Contact Information

Trial Lead Organizations/Sponsors

Rockefeller University Hospital

Peter R. Holt

Principal Investigator

U.S.A.
New York
	New York
	Rockefeller University Hospital
		Jeanne Walker, NP	Ph: 212-327-7270
			Email: walkerj@rockefeller.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01127867
Information obtained from ClinicalTrials.gov on August 06, 2012

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