Breast Pain, Non-cyclical Mastalgia, Surgical Scar-Related Breast Pain
Conditions
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.
Interventions
DRUGDiclofenac
Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks
DRUGPlacebo
Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
25 Participants were recruited at the Mayo Clinic in Rochester Minnesota from June 2005 to May 2009. Seven subjects withdrew after randomization, prior to treatment, 6 in arm A, and 1 in arm B.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 10 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 1 | 0 |
| First Intervention | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo First, Then Diclofenac (Arm A) | Diclofenac First, Then Placebo (Arm B) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 10 Participants | 18 Participants |
| Region of Enrollment United States | 8 participants | 10 participants | 18 participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 18 | 1 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
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.
Time frame: 4 weeks, 10 weeks
Primary
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.
Time frame: 4 weeks, 10 weeks
Secondary
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.
Time frame: Approximately 12 weeks and at 24 weeks after randomization