Health TrialsbyHealthPanel

Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease

ConditionIdiopathic Granulomatous Mastitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age21-60
SponsorNational University Hospital, Singapore

About this trial

This research study is to determine the effectiveness of prednisolone and methotrexate for IGM patients over a period of one year, in terms of clinical and radiological response. Recruitment will be conducted in National University Hospital (NUH) for patients diagnosed with IGM.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women, aged between 21 and 60 years

Positive diagnosis of idiopathic granulomatous mastitis based on histopathology results

Willing and able to give informed consent

Disqualifiers

Women who are currently pregnant or breastfeeding

Cognitive impairment which prevents the patient from giving voluntary consent

History of any psychiatric conditions such as depression, psychosis, schizophrenia etc.

History of cancer in the past 5 years

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prednisolone

    Drug

    20mg of prednisolone will be prescribed, taken orally, and daily for first month followed by tapering doses of 15mg over one month, then 12.5mg for one month, proceeding to 10mg for one month, subsequently taking 7.5mg for one month, and lastly 5mg for one month.

  • Methotrexate

    Drug

    10mg of methotrexate will be prescribed to be taken once a week for one month. The dosage will be increased to 15mg of methotrexate taken once a week on the 1st (T1) month clinical visit and will be further increased to 20mg of methotrexate taken once a week on the 2nd (T2) month clinical visit. There will be no further escalation of dosage after this visit.

  • Folic Acid 5 MG

    Drug

    5mg of folic acid is to be taken together with methotrexate once a week.

  • Omeprazole 20 mg

    Drug

    Omeprazole will be prescribed at 20mg to protect the stomach lining.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: SteroidActive comparator 2 interventions
Group B: MethotrexateExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients who achieved clinical or radiological complete response by 6 months

Time frame
6 months
2

Time to clinical response and time to radiological response

Time frame
6 months
3

Proportion of patients with relapse in a year within affected breast between each arm.

Time frame
1 year

Secondary outcomes

1

Evaluation of side effects.

Time frame
1 year
2

Evaluation of of treatment failure (TF) rate

Time frame
6 months
3

Evaluation of frequency of percutaneous or surgical intervention required

Time frame
6 months
4

Evaluation of potential unique pattern of gene expression that can be used to diagnose IGM and predict treatment response

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University Hospital, Singapore

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: