The radioprotective effect of metformin against radiotherapy-induced complications

The investigating of radioprotective effect of metformin against radiotherapy-induced urinary, gastrointestinal complications and genotoxicity in prostate cancer patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211213053377N1

Enrollment

Registered

2022-01-20

Start date

2022-01-21

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

Prostate cancer. Malignant neoplasm of prostate

Interventions

Intervention 1: Intervention group: Patients will receive oral metformin tablets (Chemi Darou Pharmaceutical Company, Iran) at a single dose of 1000 mg per day before the start of radiotherapy until o

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients localized prostate adenocarcinoma cancer Prescribe of definitive or postoperative external beam radiotherapy Consent to participate in the study

Exclusion criteria

Exclusion criteria: Patients with metastatic prostate cancer Previous history of radiation or chemotherapy Renal and hepatic dysfunction Patients with cardiovascular failure Patients with severe respiratory problems (such as obstructive pulmonary disease, severe asthma) Patients with blood problems (such as anemia, vitamin B12 deficiency) Diabetic patients Smoking patients

Design outcomes

Primary

Measure	Time frame
The Number of blood cells. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Laboratory measurement of blood cell count.;Genotoxicity. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Laboratory count of micronucleus in peripheral blood lymphocytes.;Urinary complications. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Evaluation of acute urinary complications due to radiation therapy based on physician examination and patient symptoms.;Gastrointestinal complications. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Evaluation of acute gastrointestinal complications due to radiation therapy based on physician examination and patient symptoms.	—

Measure

Time frame

The Number of blood cells. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Laboratory measurement of blood cell count.;Genotoxicity. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Laboratory count of micronucleus in peripheral blood lymphocytes.;Urinary complications. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Evaluation of acute urinary complications due to radiation therapy based on physician examination and patient symptoms.;Gastrointestinal complications. Timepoint: Before first session of radiotherapy, once every two weeks during radiation therapy and one months after the end of radiotherapy. Method of measurement: Evaluation of acute gastrointestinal complications due to radiation therapy based on physician examination and patient symptoms.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSina Hosseini

Ahvaz University of Medical Sciences

Larkhilv@gmail.com+98 61 3001 3374

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026