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The Impact of Metformin Administration on the Clinical Outcome of Stage IV Colon Cancer

NCT05921942 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-02-02

No results posted yet for this study

Summary

Design: Prospective, randomized controlled trial Setting: Clinical Oncology and Nuclear Medicine, Ain Shams University Condition: Colorectal cancer

Patients will be randomized into one of two groups:

Group A: Patients will receive standard therapy FOLFOX PROTOCOL Group B: Patients will receive metformin (500 mg twice daily or 1000 mg once daily) on top of standard therapy

Assessment:

Baseline Assessment:

* Patient Full History: Age, sex, smoking history, occupational history, medical history, concurrent diseases and medications.
* Laboratory data:
* Complete blood test
* Liver functional test
* Renal function test
* Inflammatory Markers: Interleukin (IL)-6

EVERY 3 MONTH: CT/MRI /PET scan to detect the response to chemotherapy and progression , Quality of life by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30. (EORTC QLQC30), Assessment of chemotherapy toxicity using CTACE 4.0 .

Every 2 CYCLE: Lab examination (CBC, Liver function, Kidney function),CTACE SIDE EFFECTS EXAMINATION AFTER 6 MONTH : iL-6 LEVELS AFTER 1 YEAR : PFS AND OS

Conditions

Interventions

DRUG

Metformin

500 mg twice daily or 1000 mg once daily

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05921942 on ClinicalTrials.gov