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

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Topical Diclofenac for the Treatment of Noncyclic Breast Pain

Conditions
-----------------
Breast Pain, Non-cyclical Mastalgia, Surgical Scar-Related Breast Pain

Intervention / Treatment
-----------------
* Drug: Diclofenac
* Drug: Placebo


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo First, then Diclofenac (Arm A)<br>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. | Drug: Diclofenac<br>* Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks<br>* Other names: Zipsor;Drug: Placebo<br>* Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks<br>|
| Experimental: Diclofenac First, then Placebo (Arm B)<br>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. | Drug: Diclofenac<br>* Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks<br>* Other names: Zipsor;Drug: Placebo<br>* Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Breast Pain | Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. The frequency of breast pain will be determined by the number of days per week that the subject recorded experiencing pain at 4 weeks and 10 weeks of each treatment. | 4 weeks, 10 weeks | 
| Severity of Breast Pain | Severity will measured using a 100 mm visual analog scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain severity VAS, 0 means no pain and 100 means extreme pain. The investigator measures the written mark of the participant in mm, and records this for the value of pain severity. The severity of breast pain will be determined by the mean of breast pain scores (determined for all days and for days for which pain is greater than 0) at 4 weeks and 10 weeks of each treatment. | 4 weeks, 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Days of Pain During the 10 Week Treatment Periods | Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. Mean number of days with pain during each 10 week treatment period will be calculated. | Approximately 12 weeks and at 24 weeks after randomization |