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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diclofenac
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Arm Label

Placebo First, then Diclofenac (Arm A)

Diclofenac First, then Placebo (Arm B)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 11, 2006
Last Updated
December 13, 2012
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00276419
Brief Title
Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin
Official Title
Topical Diclofenac for the Treatment of Noncyclic Breast Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of funds; FDA approved a topical form of diclofenac during study, no need to continue study of pharmacy-compounded drug.
Study Start Date
June 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Pain, Non-cyclical Mastalgia, Surgical Scar-Related Breast Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo First, then Diclofenac (Arm A)
Arm Type
Experimental
Arm 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.
Arm Title
Diclofenac First, then Placebo (Arm B)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Other Intervention Name(s)
Cambia, Cataflam, Voltaren, Voltarol, Zipsor
Intervention Description
Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
Primary Outcome Measure Information:
Title
Frequency of Breast Pain
Description
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.
Time Frame
4 weeks, 10 weeks
Title
Severity of Breast Pain
Description
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.
Time Frame
4 weeks, 10 weeks
Secondary Outcome Measure Information:
Title
Mean Days of Pain During the 10 Week Treatment Periods
Description
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.
Time Frame
Approximately 12 weeks and at 24 weeks after randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin L. Smith, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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