Impact Of Metformin In Rectal Cancer Patients

Minia University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Rectal Cancer Patients

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT06728982

Metformin In Rectal Cancer

Details and patient eligibility

About

Design: Prospective, randomized controlled clinical trial Setting: at Minia University Hospital and Minia Oncology Institute. Condition: Colorectal cancer.

To be eligible for participation, patients must meet the following criteria:

1. Histologically confirmed diagnosis of rectal adenocarcinoma.
2. Age starting from 18 and older.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4. Adequate organ function (renal, hepatic, and hematological)
5. Signed informed consent.

Patients will be randomized into two groups:

Group A: Patients will receive standard chemoradiotherapy(CRT).

Group B: Patients will self-administer 1000mg of metformin twice daily by mouth:

1. beginning 1-2 weeks before standard CRT.
2. during standard CRT.
3. until 30 days after the end of standard CRT.

Enrollment: 85 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed diagnosis of rectal adenocarcinoma.
2. Age starting from 18 and older.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4. Adequate organ function (renal, hepatic, and hematological)
5. Signed informed consent.

Exclusion criteria

1. Metastatic disease.
2. Contraindications to metformin.
3. Significant comorbidities or medical conditions that may interfere with study participation. (D.M, PCO,..)
4. eGFR less than 30 mL/min.
5. Pregnant or breastfeeding women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 2 patient groups

Group A

No Intervention group

Description:

Patients will receive standard chemoradiotherapy(CRT)

Group B (Metformin)

Active Comparator group

Description:

Patients will self-administer 1000mg of metformin twice daily by mouth: 1. beginning 1-2 weeks before standard CRT. 2. during standard CRT. 3. until 30 days after the end of standard CRT.

Treatment:

Drug: Metformin