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role of metformin in non-cancerous breast lumps

effectiveness of metformin in fibro-cystic disease of breast : A randomized control trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000165381
Enrollment
88
Registered
2026-02-10
Start date
2026-03-02
Completion date
2026-03-27
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

fibrocystic disease of breast is common health problem which not well understood and not well attended. with the rising awareness about breast cancer in female population there is a colossal number of female reporting to breast clinic with signs and symptoms of fibrocystic breast disease. we feel the need that this condition must be presented in effective way to reduce repetitive presentation. Metformin can be a effective solution. metformin has been high lighted in western studies for its effectiveness in fibrocystic disease.

Interventions

the intervention group will be prescribed Oral metformin in a dose of 500 mg twice daily along with paracetamol 1000 mg PRN for pain relief when required not exceeding 4 grams /day for a period of 3 months. The control group will only be prescribed paracetamol in the dose of 100mg PRN or as required not exceeding 4grams/day for three months . All patients will be asked for follow up at 3 weekly intervals they will be given a call to reach on appointment day on the morning of booked appointme

the intervention group will be prescribed Oral metformin in a dose of 500 mg twice daily along with paracetamol 1000 mg PRN for pain relief when required not exceeding 4 grams /day for a period of 3 months. The control group will only be prescribed paracetamol in the dose of 100mg PRN or as required not exceeding 4grams/day for three months . All patients will be asked for follow up at 3 weekly intervals they will be given a call to reach on appointment day on the morning of booked appointment.. At each follow-up, compliance with medication would be verbally confirmed from all patients.. Pain relief would be assessed on visual analogue score (VAS) while Ultrasound study would be performed to assess the number and size pf the cystic cluster in the affected breast(s) and compare with the baseline ultrasound and visual analogue scale.

Sponsors

DR ALMAS AFRIDI KHYBER TEACHING HOSPITAL PESHAWAR
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
25 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

all women with child bearing age and diagnosed fibrocystic disease on ultrasound of the breast

Exclusion criteria

*patient with active arthritis or musculoskeletal condition as it confounding factor *male gender *women who are lactating or pregnant

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026