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

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

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

Study Overview

• Status: Completed
• Conditions: Cyclical Breast Pain
• Intervention / Treatment: Drug: Vitamin E, Evening Oil of Primrose, and Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: New Health International
• Investigators: Principal Investigator: Sandhya Pruthi, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: January 10, 2006
• First Submitted That Met QC Criteria: January 10, 2006
• First Posted (Estimate): January 12, 2006

Study Record Updates

• Last Update Posted (Estimate): November 26, 2009
• Last Update Submitted That Met QC Criteria: November 25, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mastodynia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E
• Other Study ID Numbers: 1957-02