A Randomized Controlled Trial Study on the Effectiveness of Local Injection combined with with Systemic therapy and Topical Steroids injection alone or Systemic therapy alone in the Treatment of Idiopathic Granulomatous Mastitis
This study aims to evaluate the Effectiveness of Local Steroid Injection alone, in comparison with Steroid injection Combined with Systemic therapy vs. Systemic therapy alone in the Treatment of Idiopathic Granulomatous Mastitis
Design
A randomized clinical trial with three intervention parallel groups, that 90 patients will be enrolled in phase 2. Random Allocation Software will use for block randomization.
Settings and conduct
This study will be conducted in the Breast Diseases Research Center. Patients will be allocated into one of the three groups. Group one will be treated with Local steroid injection followed by systemic oral corticosteroid and MTX as systemic treatment. Group two will be treated with systemic oral corticosteroid and MTX as systemic treatment. Group three will be treated with Local steroid injection by the physician once a week.
Participants/Inclusion and exclusion criteria
Idiopathic Granulomatous Mastitis female patients aged between 18-65 who require not a surgical treatment without other malignancy or breast cancer.
Intervention groups
All Patients will treat with 2-week oral antibiotics (Ciprofloxacin, Metronidazole).The patients will allocate in three study groups, randomly. Group one, will be treated with local steroid injection by the physician once a week for one to four times (betamethasone LA injection) and followed by oral corticosteroid(Prednisolon) and MTX as systemic treatment. Group two will include oral corticosteroid and MTX as systemic treatment. Group three will be treated with Steroid injection to the breast by the physician once a week for one to four times.
Main outcome variables
Disappearance of inflammatory signs, closure of fistula orifices,and skin erosions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047694N1
Registration date:2020-07-21, 1399/04/31
Registration timing:registered_while_recruiting
Last update:2020-07-21, 1399/04/31
Update count:0
Registration date
2020-07-21, 1399/04/31
Registrant information
Name
Vahid Zangouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 1000
Email address
zangouri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-23, 1399/03/03
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized Controlled Trial Study on the Effectiveness of Local Injection combined with with Systemic therapy and Topical Steroids injection alone or Systemic therapy alone in the Treatment of Idiopathic Granulomatous Mastitis
Public title
Effectiveness of Local Injection (Bethametasone LA) combined with Systemic therapy (Methotraxate and Prednisolone)and Topical Steroids injection alone or Systemic therapy alone in the Treatment of Idiopathic Granulomatous Mastitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients with Idiopathic Granulomatosis Mastitis
Female patients aged 18-65
Female patients with Idiopathic Granulomatosis Mastitis which require non-surgical treatment
Exclusion criteria:
Female patients with Idiopathic Granulomatosis Mastitis who has abcess
Female patients with Idiopathic Granulomatosis Mastitis which require surgical intervention or has breast cancer or other malignancy
Age
From 18 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In order to avoid selection bias all the patients allocated to three groups by blocked randomization. It ensures that participants are assigned to groups with equal probability. In this study the size of each block is equal and consist of three patients. The treatments are randomly allocated to the experimental units inside each block and all treatments appear at least once in each block
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Karimkhan Zand Avenue ,Namazee square, shahid motahhari clinic.Breast diseases research center
City
SHIRAZ
Province
Fars
Postal code
۷۱۳۴۸-۷۱۴۷۳۷
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.SUMS.MED.REC.1399.096
Health conditions studied
1
Description of health condition studied
Idiopathic Granulomatous Mastitis
ICD-10 code
N61
ICD-10 code description
Inflammatory disorders of breast
Primary outcomes
1
Description
The disappearance of inflammatory signs
Timepoint
All Patients will be followed weekly in first month and then monthly for 5 months for detect symptoms
Method of measurement
The clinical response is categorized into completely healed, inadequately healed, stable, worsened, or relapsed that will be evaluated by surgeon.
2
Description
Closure of fistula orifices
Timepoint
All Patients will be followed weekly in the first month and then monthly for 5 months to detect symptoms
Method of measurement
The clinical response is categorized into completely healed, inadequately healed, stable, and worsened that will be evaluated by the surgeon.
3
Description
Disappearance of skin erosion
Timepoint
All Patients will be followed weekly in the first month and then monthly for 5 months to detect symptoms
Method of measurement
The clinical response is categorized into completely healed, inadequately healed, stable, and worsened that will be evaluated by the surgeon.
Secondary outcomes
1
Description
granulomatous mastitis recurrence in the Ipsilateral breast
Timepoint
All Patients will be exam by surgeon and sonography will be done for all of them at the last month of follow up
Method of measurement
The occurrence of Granulomatosis Mastitis will be assessed by the surgeon and doing sonography.
Intervention groups
1
Description
Group one (N=30, systemic therapy plus local steroid injection) will be treated with Local steroid injection to the breast by the physician once a week for one to four times (betamethasone LA injection, each injection contains betamethasone Acetate at 3 mg and betamethasone disodium phosphate 3 mg/ml) and followed by systemic oral corticosteroid and Methotrexate (MTX) as systemic treatment (MTX 10 mg PO per week for 5 months and prednisolone 1mg/kg/day for the first month, then taper to 5 mg/day in 4 months following months)
Category
Treatment - Drugs
2
Description
Intervention group 2: Group two (N=30) will include systemic oral Corticosteroid and MTX as systemic treatment (MTX 10 mg PO per week for 2 months and Prednisolone 1mg/kg/day for the first month, then taper to 5 mg/day in 4 months following months)
Category
Treatment - Drugs
3
Description
Intervention group3: Group three (N=30) will be treat with Local steroid injection to the breast by the physician once a week for one to four times (Betamethasone LA injection, each injection contains Betamethasone Acetate at 3 mg and Betamethasone disodium phosphate 3 mg/ml)