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

Mayo Clinic

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Surgical Scar-Related Breast Pain; Non-cyclical Mastalgia; Breast Pain

Treatments: Drug: Diclofenac; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00276419

92-05

Details and patient eligibility

About

The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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25 participants in 2 patient groups

Placebo First, then Diclofenac (Arm A)

Experimental group

Description:

Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.

Treatment:

Drug: Placebo

Drug: Diclofenac

Diclofenac First, then Placebo (Arm B)

Experimental group

Description:

Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.

Treatment:

Drug: Placebo

Drug: Diclofenac