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

NCT05921942 | Completed Phase 3 DMC

• 1 other identifier: 262
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer

Keywords

metformin; Colorectal cancer; FOLFOX

Outcome Measures

Primary Outcomes (2)

• Disease Control Rate according to Response evaluation criteria in solid tumors ( RECIST) 1.1

  defined as tumor response of patients in Complete remission, partial remission or stable disease from randomization of first subject until database cutoff at 6 month interval

  6 months

• Progression free survival

  1 YEAR

Secondary Outcomes (3)

• IL-6 Levels

  6 months

• Overall Survival

  1 YEAR

• Common terminology criteria adverse events (CTCAE 4.0)

  4 Weeks

Study Arms (2)

Group A

NO INTERVENTION

Patients will receive standard therapy FOLFOX/XELOX PROTOCOL

Group B

ACTIVE COMPARATOR

Patients will receive metformin (500 mg twice daily or 1000 mg once daily) in addition to standard therapy FOLFOX/XELOX PROTOCOL

Drug: Metformin

Interventions

Metformin DRUG

500 mg twice daily or 1000 mg once daily

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A- •Patients above 18 years old and above B- •Patients who approved to be enrolled in study by documented consent C- Patients with metastatic colon cancer D- NON -Diabetic patients
• E- Patients with satisfactory hematological and biochemical functions defined as:
• I. Platelets (Plts) \>100 x 10\^9 II. Creatinine Clearance (Crcl) \>60 ml/min or \>45-59 but receive single dose of medication III. Aspartate Aminotransferase (AST) AND Alanine Aminotransferases (ALT) \<2.5 ULN IV. Absolute Neutrophilic count (ANC) \>1,500 / mm\^3 V. Eastern Cooperative Oncology Group (ECOG) performance 0-2

You may not qualify if:

• Patients with hypersensitivity to metformin, renal or hepatic impairment that may predispose lactic acidosis
• Patients with previous or current severe breathing problems (as obstructive lung disease, severe asthma) or dehydration

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11314, Egypt

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: Patients who fulfill the inclusion criteria will be recruited and 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

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 27, 2023
• Study Start: April 15, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

EG (1)