Official Title: “Topical Diclofenac for the Treatment of Noncyclic Breast Pain”

Pain is the most common symptom affecting the breast and frequently accounts for breast-related medical evaluations in the United States. Most women with breast pain are reassured following a negative evaluation and do not desire treatment; however, for some, the pain is sufficiently frequent and severe that treatment for pain relief is warranted.

Medications available to treat breast pain are primarily hormonal in nature with potentially serious adverse effects. There is a need for well-tolerated, effective interventions for breast pain, particularly for noncyclic and surgical scar-related pain. Studies of topical nonsteroidal antiinflammatory agents in the treatment of breast pain are few and have had mixed results. The present study is designed to determine whether topical diclofenac is effective for the treatment of breast pain.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: November 2008

A prospective, randomized, double-blinded crossover trial comparing topical diclofenac and placebo for 10 weeks in the treatment of 30 women with noncyclic mastalgia and surgical scar-related breast pain. The primary endpoints are the frequency and severity of breast pain measured before, during and upon completion of therapy using a breast pain diary and visual analog scale. Adherence to treatment and side effects will also be compared between the groups.

Intervention(s) in this Clinical Trial

• Drug: Compounded topical formulation of diclofenac
  • Topical diclofenac or placebo cream applied to the skin three times daily for 10 weeks each

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Crossover study. There are two study arms, with subjects in each arm receiving study medication (topical diclofenac or placebo) for 10 weeks. The two arms differ only in the order of medication exposure.
• Other: 2
  • Crossover study. There are two arms in the study, patients receive study medication (topical diclofenac or placebo) for 10 weeks each, differing only in the order of medication exposure.

Primary Measures

• Frequency of breast pain
  • Time Frame: 6 months study
    Safety Issue?: No
• Severity of breast pain
  • Time Frame: 6 month study
    Safety Issue?: No

Secondary Measures

• Side effects
  • Time Frame: 6 month study
    Safety Issue?: Yes
• Adherence
  • Time Frame: 6 month study
    Safety Issue?: No
• Level of anxiety generated by breast symptoms
  • Time Frame: 6 month study
    Safety Issue?: No

Inclusion criteria

• 1. Noncyclic mastalgia or surgical scar-related pain occurring on at least 2 days per week and for which the patient desires treatment
• 2. Duration of pain > 2 months (noncyclic mastalgia) or > 4 months (surgical scar-related pain)
• 3. Age > 18 years
• 4. Satisfactory breast examination and directed ultrasound at site of pain (all ages) within 12 months
• 5. Satisfactory mammogram (all women > 30 years of age) within 12 months
• 6. Negative pregnancy test (all women who are premenopausal and have not had hysterectomy or tubal ligation)

Exclusion criteria

• 1. Cyclic mastalgia (as defined above)
• 2. Duration of pain > 2 months (noncyclic mastalgia) or > 4 months (surgical scar-related pain)
• 3. Age < 18 years
• 4. Abnormal breast examination or imaging (abnormality at the site of pain or for which biopsy or surgical consultation is recommended)
• 5. Known pregnancy, lactation, positive pregnancy test or anticipated pregnancy within 6 months
• 6. Asthma, that has been aggravated by oral nonsteroidal antiinflammatory agents
• 7. Allergy, to diclofenac or any nonsteroidal antiinflammatory agents
• 8. Rash or open lesions at the site on the breast where the topical agent would be applied
• 9. Incomplete or abnormal healing (surgical scar-related pain)
• 10. History of gastrointestinal ulceration, renal dysfunction (creatinine >1.5), hepatic disease (known liver disease or AST twice normal levels), congestive heart failure and uncontrolled hypertension (blood pressure > 140/90)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mayo Clinic

Overall Clinical Trial Officials and Contacts

Robin L. Smith, M.D. Principal Investigator Mayo Clinic  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00276419

Study ID Number: 92-05

ClinicalTrials.gov Identifier: NCT00276419

Health Authority: United States: Institutional Review Board

Mayo Clinic Clinical Trials