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

Phase 2

Terminated

• Conditions: Breast Pain; Non-cyclical Mastalgia; Surgical Scar-Related Breast Pain
• Interventions: Drug: Diclofenac; Drug: Placebo

• Registration Number: NCT00276419
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-13
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2012-11-16
• Results First Submitted QC: 2012-11-16
• Status Verified: 2012-12
• Results First Posted: 2012-12-13
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo First, then Diclofenac (Arm A)	Placebo	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.
Diclofenac First, then Placebo (Arm B)	Placebo	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.
Placebo First, then Diclofenac (Arm A)	Diclofenac	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.
Diclofenac First, then Placebo (Arm B)	Diclofenac	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.

Primary Outcome Measures

Name	Time	Method
Frequency of Breast Pain	4 weeks, 10 weeks	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.
Severity of Breast Pain	4 weeks, 10 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Mean Days of Pain During the 10 Week Treatment Periods	Approximately 12 weeks and at 24 weeks after randomization	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States