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Implication of Metformin Plus Aromatase Inhibitor in Obese Postmenopausal Breast Cancer Women

Primary Purpose

Metformin, Breast Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Metformin
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metformin

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Postmenopausal women, postmenopausal is defined either by:

A. Age ≥ 55 years and one year or more of amenorrhea. B. Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/ml.

• Patients with breast cancer indicated for hormonal treatment with aromatase inhibitors (overweight 30 > BMI ≥ 25, obese BMI ≥ 30 kg/m2 and non obese BMI between 18 and 25 kg/m2).

Exclusion Criteria:

  • • Diabetic patients.

    • Patients with metabolic syndrome.
    • Patients with last menstrual cycle less than one year ago.
    • Patient with conditions predispose to acidosis (heart failure, renal failure).
    • Ovarian radiation treatment with luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    No Intervention

    Arm Label

    Control group

    metformin group

    lean group

    Arm Description

    fifteen obese females who received letrozole only

    fifteen obese females who received the same dose of letrozole plus metformin (2000 ± 500) mg daily

    fifteen non- obese breast cancer females who received letozole for six months, treatment period

    Outcomes

    Primary Outcome Measures

    change in serum level of the study biomarkers after treatment when compared with baseline values
    measuring the serum levels of the studied biomarkers

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2021
    Last Updated
    September 13, 2021
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05053841
    Brief Title
    Implication of Metformin Plus Aromatase Inhibitor in Obese Postmenopausal Breast Cancer Women
    Official Title
    Implication of Combined Adjuvant Metformin and Aromatase Inhibitor in Overweight or Obese Postmenopausal Breast Cancer Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (Actual)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University

    4. Oversight

    5. Study Description

    Brief Summary
    Metformin is an anti-diabetic oral hypoglycemic agent that considered the gold standard therapy for the treatment of type 2 diabetes. Retrospective analyses show that metformin can offer therapeutic benefits to patients with several forms of cancer. It also has positive weight reducing effect on non-diabetic patient by improving insulin sensitivity (although the exact underlying pathomechanisms remain to be elucidated).
    Detailed Description
    This prospective controlled study aimed to evaluate the effect of combined metformin adjuvant therapy and aromatase inhibitors (letrozole) in postmenopausal obese breast cancer women. In addition, to evaluate the effect of weight reduction on aromatase inhibitor efficacy. Patients and methods: From February 2014 to June 2015, 75 Post-menopausal breast cancer females' patients were recruited, 53 patients underwent randomization and 45 patients completed six months, treatment. Aromatase inhibitor (letrozole) was administered as once daily in accordance to one of the three groups. Control group: fifteen obese females who received letrozole only; metformin group: fifteen obese females who received the same dose of letrozole plus metformin (2000 ± 500) mg daily, and lean group: fifteen non- obese breast cancer females who received letozole for six months, treatment period. Blood samples were collected at baseline and after six months of aromatase inhibitors treatment for analysis of serum estradiol, osteocalcin, insulin, leptin, lactate and glucose.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metformin, Breast Cancer

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    fifteen obese females who received letrozole only
    Arm Title
    metformin group
    Arm Type
    Active Comparator
    Arm Description
    fifteen obese females who received the same dose of letrozole plus metformin (2000 ± 500) mg daily
    Arm Title
    lean group
    Arm Type
    No Intervention
    Arm Description
    fifteen non- obese breast cancer females who received letozole for six months, treatment period
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Other Intervention Name(s)
    Glucophage
    Primary Outcome Measure Information:
    Title
    change in serum level of the study biomarkers after treatment when compared with baseline values
    Description
    measuring the serum levels of the studied biomarkers
    Time Frame
    six months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Postmenopausal women, postmenopausal is defined either by: A. Age ≥ 55 years and one year or more of amenorrhea. B. Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/ml. • Patients with breast cancer indicated for hormonal treatment with aromatase inhibitors (overweight 30 > BMI ≥ 25, obese BMI ≥ 30 kg/m2 and non obese BMI between 18 and 25 kg/m2). Exclusion Criteria: • Diabetic patients. Patients with metabolic syndrome. Patients with last menstrual cycle less than one year ago. Patient with conditions predispose to acidosis (heart failure, renal failure). Ovarian radiation treatment with luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression.

    12. IPD Sharing Statement

    Learn more about this trial

    Implication of Metformin Plus Aromatase Inhibitor in Obese Postmenopausal Breast Cancer Women

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