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

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ClinicalTrials.gov Identifier: NCT00276419
Recruitment Status : Terminated (Lack of funds; FDA approved a topical form of diclofenac during study, no need to continue study of pharmacy-compounded drug.)
First Posted : January 13, 2006
Results First Posted : December 13, 2012
Last Update Posted : December 20, 2012
Sponsor:
Information provided by:
Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Pain Non-cyclical Mastalgia Surgical Scar-Related Breast Pain Drug: Diclofenac Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Diclofenac for the Treatment of Noncyclic Breast Pain
Study Start Date : June 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Placebo First, then Diclofenac (Arm A)
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
Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks
Other Names:
  • Cambia
  • Cataflam
  • Voltaren
  • Voltarol
  • Zipsor

Drug: Placebo
Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
Experimental: Diclofenac First, then Placebo (Arm B)
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
Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks
Other Names:
  • Cambia
  • Cataflam
  • Voltaren
  • Voltarol
  • Zipsor

Drug: Placebo
Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of Breast Pain [ Time Frame: 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.

  2. Severity of Breast Pain [ Time Frame: 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 :
  1. Mean Days of Pain During the 10 Week Treatment Periods [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276419


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Robin L. Smith, M.D. Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Robin L. Smith, MD; principal investigator, Division of General Internal Medicine, Mayo Clinic, Rochester Minnesota
ClinicalTrials.gov Identifier: NCT00276419    
Other Study ID Numbers: 92-05
First Posted: January 13, 2006    Key Record Dates
Results First Posted: December 13, 2012
Last Update Posted: December 20, 2012
Last Verified: December 2012
Additional relevant MeSH terms:
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Mastodynia
Pain
Neurologic Manifestations
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action