Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin

Condition(s) targeted: Breast Pain; Non-Cyclical Mastalgia; Surgical Scar-Related Breast Pain

Intervention: Compounded topical formulation of diclofenac (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Robin L. Smith, M.D., Principal Investigator, Affiliation: Mayo Clinic

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.

Official title: Topical Diclofenac for the Treatment of Noncyclic Breast Pain

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

Primary outcome:

Frequency of breast pain

Severity of breast pain

Secondary outcome:

Side effects

Adherence

Level of anxiety generated by breast symptoms

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion criteria

1. Noncyclic mastalgia or surgical scar-related pain occurring 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)

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Brianna J Crawford, Phone: 507-538-7946, Email: Crawford.Brianna@mayo.edu
Robin L Smith, MD, Principal Investigator

Mayo Clinic Clinical Trials

Starting date: June 2005
Ending date: December 2008
Last updated: September 12, 2008