Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Breast Pain

Study Overview
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Brief Summary
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This study is being done to find out what effects Vitamin E or Evening Oil of Primrose has on cyclical breast pain.

Detailed Description
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Cyclical mastalgia is a common complaint of women presenting to their primary care physicians. Cyclical breast pain is defined as prementstrual breast discomfort associated with hormonal fluctuations during the menstrual cycle. A clinical breast examination and sometimes additional imaging, such as sonography or mammography, is required as part of the evaluation to exclude malignancy. For most women, the symptoms are effectively managed with reassurance and conservative treatment measures such as the use of a supportive bra or over the counter pain medication such as acetaminophen or anti-inflammatories. However, a small number of women will require additional drug treatment with danazol after failing to respond to conservative measures. Unfortunately, danazol is associated with significant side effects. In the Mayo Breast Clinic, women with cyclical breast pain are managed with Vitamin E and Evening oil of primrose (EOP) either as single agents or in combination. These over the counter supplements are readily available, acceptable due to minial side effects and appear to lead to significant reduction in breast pain. We propose a randomized placebo controlled trial to determine if any vitamin E or EOP or the combination of both are effective in managing cyclical breast pain.

Official Title
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Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Cyclical Breast Pain

Conditions
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Cyclical Breast Pain

Intervention / Treatment
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* Drug: Vitamin E, Evening Oil of Primrose, and Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older premenopausal cyclical breast pain breast pain survey indicating 3 or more on scale of 1-10 if > 40 years of age, need normal mammogram and/or ultrasound if indicated and if not done within the last year if < 40 years of age, a directed ultrasound in the area of pain can be on oral contraceptives

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 56 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vitamin E, Evening Oil of Primrose, and Placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test if Vitamin E improves cyclical breast pain |  |  | 
| Test if Evening Oil of Primrose improves cyclical breast pain |  |  | 
| Test if combination of Evening Oil of Primrose and Vitamin E works synergistically for cyclial breast pain |  |  |