Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin - Full Text View

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00276419

Purpose

Pain is the most common symptom affecting the breast and frequently accounts for breast-related medical evaluations in the United States. Most women with breast pain are reassured following a negative evaluation and do not desire treatment; however, for some, the pain is sufficiently frequent and severe that treatment for pain relief is warranted. Medications available to treat breast pain are primarily hormonal in nature with potentially serious adverse effects. There is a need for well-tolerated, effective interventions for breast pain, particularly for noncyclic and surgical scar-related pain. Studies of topical nonsteroidal antiinflammatory agents in the treatment of breast pain are few and have had mixed results. The present study is designed to determine whether topical diclofenac is effective for the treatment of breast pain.

Condition	Intervention	Phase
Breast Pain Non-cyclical Mastalgia Surgical Scar-Related Breast Pain	Drug: Compounded topical formulation of diclofenac Drug: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Topical Diclofenac for the Treatment of Noncyclic Breast Pain

Resource links provided by NLM:

MedlinePlus related topics: Breast Diseases Scars

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Frequency of breast pain [ Time Frame: 6 months study ] [ Designated as safety issue: No ]
Severity of breast pain [ Time Frame: 6 month study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Side effects [ Time Frame: 6 month study ] [ Designated as safety issue: Yes ]
Adherence [ Time Frame: 6 month study ] [ Designated as safety issue: No ]
Level of anxiety generated by breast symptoms [ Time Frame: 6 month study ] [ Designated as safety issue: No ]

Enrollment:	27
Study Start Date:	June 2005
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Crossover study. There are two study arms, with subjects in each arm receiving study medication (topical diclofenac or placebo) for 10 weeks. The two arms differ only in the order of medication exposure.	Drug: Compounded topical formulation of diclofenac Topical diclofenac or placebo cream applied to the skin three times daily for 10 weeks each
Placebo Comparator: 2 Crossover study. There are two arms in the study, patients receive study medication (topical diclofenac or placebo) for 10 weeks each, differing only in the order of medication exposure.	Drug: Placebo Placebo

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. The primary endpoints are the frequency and severity of breast pain measured before, during and upon completion of therapy using a breast pain diary and visual analog scale. Adherence to treatment and side effects will also be compared between the groups.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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)
Age < 18 years
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 AST twice normal levels), congestive heart failure and uncontrolled hypertension (blood pressure > 140/90)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276419

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Robin L. Smith, M.D.

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Robin L. Smith, MD; principal investigator, Division of General Internal Medicine, Mayo Clinic, Rochester Minnesota
ClinicalTrials.gov Identifier:	NCT00276419 History of Changes
Other Study ID Numbers:	92-05
Study First Received:	January 11, 2006
Last Updated:	December 4, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012