Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
85 participants
INTERVENTIONAL
2024-05-01
2025-07-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
SINGLE
Study Groups
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Group A
Patients will receive standard chemoradiotherapy(CRT)
No interventions assigned to this group
Group B (Metformin)
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.
Metformin
1000mg of metformin twice daily by mouth
Interventions
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Metformin
1000mg of metformin twice daily by mouth
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Minia University
OTHER
Responsible Party
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Omar Mohamed Awad
Teaching Assistant
Principal Investigators
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Omar M Awad, Bsc
Role: PRINCIPAL_INVESTIGATOR
Deraya University
Fatma M Mady, professor
Role: STUDY_CHAIR
Minia University
Mona A Saber, PhD
Role: STUDY_DIRECTOR
Minia University
Locations
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Minia Oncology Center
Minya, Egypt, Egypt
Minia University Hospital
Minya, Egypt, Egypt
Countries
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Other Identifiers
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Metformin In Rectal Cancer
Identifier Type: -
Identifier Source: org_study_id
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