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

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT05053841
Collaborator
(none)
45
Enrollment
3
Arms
15.9
Actual Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Implication of Combined Adjuvant Metformin and Aromatase Inhibitor in Overweight or Obese Postmenopausal Breast Cancer Women
Actual Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

fifteen obese females who received letrozole only
Active Comparator: metformin group

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

Drug: Metformin
Other Names:
  • Glucophage

    		•
    No Intervention: lean group

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

    Outcome Measures

    Primary Outcome Measures

    1. change in serum level of the study biomarkers after treatment when compared with baseline values [six months]

      measuring the serum levels of the studied biomarkers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Postmenopausal women, postmenopausal is defined either by:
    1. 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tanta University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aya Ahmed El Attar, Dr Aya Ahmed El Attar, Tanta University
    ClinicalTrials.gov Identifier:
    NCT05053841
    Other Study ID Numbers:
    • 22014
    First Posted:
    Sep 23, 2021
    Last Update Posted:
    Sep 23, 2021
    Last Verified:
    Aug 1, 2021
    Additional relevant MeSH terms:
    Breast Neoplasms
    Metformin

    Study Results

    No Results Posted as of Sep 23, 2021