Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin
Breast Pain, Non-cyclical Mastalgia, Surgical Scar-Related Breast Pain
About this trial
This is an interventional treatment trial for Breast Pain
Eligibility 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)
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Placebo First, then Diclofenac (Arm A)
Diclofenac First, then Placebo (Arm B)
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.
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.