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

This study has been completed.
Sponsor:
Collaborator:
New Health International
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275600
First received: January 10, 2006
Last updated: November 25, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Cyclical Breast Pain
Drug: Vitamin E, Evening Oil of Primrose, and Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Cyclical Breast Pain

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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

Enrollment: 82
Study Start Date: January 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 56 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275600

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
New Health International
Investigators
Principal Investigator: Sandhya Pruthi, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Sandhya Pruthi, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275600     History of Changes
Other Study ID Numbers: 1957-02
Study First Received: January 10, 2006
Last Updated: November 25, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014