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Effect of Metformin on Preventing Chemotherapy-Induced Neuropathy in Breast Cancer Patients

Evaluation of Metformin Effects on the Expression of lncRNA MALAT1 and lncRNA XIST in Paclitaxel-Induced Neuropathy in Breast Cancer Patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250809066797N1
Enrollment
45
Registered
2025-09-11
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Breast cancer patients undergoing paclitaxel-based chemotherapy. Malignant neoplasm of breast

Interventions

Intervention 1: Patients in the intervention group receive metformin in addition to paclitaxel chemotherapy. The prescribed dose of metformin is 1500 mg daily, administered as three 500 mg tablets thr

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Female patients with histologically confirmed breast cancer (diagnosed by biopsy) Age = 18 years Eligible for paclitaxel-based chemotherapy

Exclusion criteria

Exclusion criteria: History or presence of active diabetes mellitus Pre-existing neuropathy or neurological disorders Anemia Prior chemotherapy exposure Active thyroid disease Gastrointestinal disorders leading to poor tolerability of metformin Any contraindication for metformin administration

Design outcomes

Primary

MeasureTime frame
Severity of chemotherapy-induced neuropathy. Timepoint: Before intervention (baseline) - Three months after intervention. Method of measurement: Neuropathy severity assessed using CTCAE and PNQ questionnaires.;Expression levels of lncRNAs MALAT1 and XIST. Timepoint: Before intervention (baseline) - Three months after intervention. Method of measurement: Gene expression measured by Real-Time PCR.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Mahmoudian-Sani

Ahvaz University of Medical Sciences

mohamadsani495@gmail.com+98 913 773 3269

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026