Evaluation of Metformin impact on the downstaging of rectal cancer patients undergoing neo-adjuvant chemo-radiotherapy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170728035349N2

Enrollment

Registered

2022-01-15

Start date

2022-01-29

Completion date

Unknown

Last updated

2022-02-07

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

Conditions

Rectal Cancer. Malignant carcinoid tumor of the rectum

Interventions

Intervention 1: Intervention group: 20 patients in the intervention group receive one metformin 500 tablet daily from Tehran Daroo Company at the same time with 28 sessions of chemoradiotherapy. Inter

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Having rectal cancer and being a candidate for neo-adjuvant chemo-radiotherapy Age over 20 and under 70 years

Exclusion criteria

Exclusion criteria: Previous history of liver or kidney disease Previous history of moderate to severe heart failure History of MI during the last 6 months

Design outcomes

Primary

Measure	Time frame
Down Staging in Rectal Cancer Patients in Neo-adjuvant and Metformin Concomitant Recipients. Timepoint: MRI and biopsy of the rectal mucosa to determine the stage of the tumor and compare with similar cases performed at the beginning of the study, Follow-up of patients in both groups at intervals of 1, 3 and 6 months in terms of possible treatment complications, non-recurrent survival, cancer-specific survival and overall survival. Method of measurement: MRI.	—

Measure

Time frame

Down Staging in Rectal Cancer Patients in Neo-adjuvant and Metformin Concomitant Recipients. Timepoint: MRI and biopsy of the rectal mucosa to determine the stage of the tumor and compare with similar cases performed at the beginning of the study, Follow-up of patients in both groups at intervals of 1, 3 and 6 months in terms of possible treatment complications, non-recurrent survival, cancer-specific survival and overall survival. Method of measurement: MRI.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZhaleh Karimimoghaddam

Zanjan University of Medical Sciences

zhkarimi@zums.ac.ir+98 24 3302 3754

Outcome results

None listed

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