Back to results

The Effect of Metformin on Breast Cancer Patients

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Metformin

Chemotherapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Metformin, Breast cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Non-diabetic breast cancer patients, receiving neoadjuvant chemotherapy treatment.
Female Age between 18- 65 years.
Written informed consent.

Exclusion Criteria:

Known hypersensitivity reaction to Metformin.
Intolerable Metformin GI complaints.
Patients at risk of lactic acidosis.
Diabetic breast cancer patients.
Body Mass Index < 18.5 (underweight breast cancer patients).
Renal impairment, eGFR <45 mL/min/1.73 m².

Sites / Locations

Beni-suef universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

metformin arm

control arm

Arm Description

4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel+ Metformin (1000 mg twice daily) followed by surgery.

4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel followed by surgery.

Outcomes

Primary Outcome Measures

Clinical benefit rate (Tumor size)

Tumor size measured in calipers from baseline till the last cycle of neoadjuvant chemotherapy.

Secondary Outcome Measures

Pathological complete response

The absence of residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.

Number of participants with metformin-related adverse events

Safety and tolerability of conventional anti-diabetic dose of metformin use in breast cancer patients.

The effect of metformin on the quality of life of breast cancer patients

A comparison between the metformin arm and the control arm in the change of quality of life from baseline using the European Organization for Research and Treatment of Cancer (EORTC QLQ C30 tools. Scoring of the EORTC QLQ-C30 is performed according to the EORTC scoring manual. After the scoring procedures, all the responses to likert-scale items were linearly transformed to a 0-100 scale. Higher scores for functional scales and the global quality of life scale, indicate better quality of life, while for symptom scales and single items, a higher score indicates a higher severity of the symptoms and worse quality of life.

The effect of metformin on the quality of life of breast cancer patients

A comparison between the metformin arm and the control arm in the change of quality of life from baseline using the European Organization for Research and Treatment of Cancer (EORTC QLQ BR45).Scoring of the EORTC QLQ-Br45 is performed according to the EORTC scoring manual. After the scoring procedures, all the responses to likert-scale items were linearly transformed to a 0-100 scale. Higher scores for functional scales and the global quality of life scale, indicate better quality of life, while for symptom scales and single items, a higher score indicates a higher severity of the symptoms and worse quality of life

Full Information

NCT ID

NCT04559308

First Posted

August 22, 2020

Last Updated

September 16, 2020

Sponsor

Beni-Suef University

Collaborators

Ahram Canadian University

1. Study Identification

Unique Protocol Identification Number

NCT04559308

Brief Title

The Effect of Metformin on Breast Cancer Patients

Official Title

The Effect of Metformin on Breast Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2019 (Actual)

Primary Completion Date

September 15, 2020 (Actual)

Study Completion Date

October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beni-Suef University

Collaborators

Ahram Canadian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

Several clinical trials have addressed the promising anticancer effect of metformin on the survival benefits, clinical response, and pathological response of breast cancer patients. Therefore, this study will assess the anticancer effect of metformin when added to the neoadjuvant chemotherapy protocol of non-diabetic breast cancer patients. In addition to, the impact of metformin addition to the neoadjuvant chemotherapy on the quality of life of breast cancer patients.

Detailed Description

This study is conducted to assess the effect of metformin addition to the chemotherapy protocol of non-diabetic breast cancer patients compared to the control group (non-metformin users) in the neoadjuvant setting. Evaluation of the the clinical benefit rate and the rate of pathological complete response will be conducted. In addition, a correlation between the beneficial effect of metformin and the serum concentration of metformin. Also, a comparison in the quality of life between the metformin group and the control group will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and (EORTC QLQ BR45) questionnaires will be done.

6. Conditions and Keywords

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

Breast Cancer

Keywords

Metformin, Breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

The study is an open-labeled, parallel, randomized controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

metformin arm

Arm Type

Experimental

Arm Description

4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel+ Metformin (1000 mg twice daily) followed by surgery.

Arm Title

control arm

Arm Type

Active Comparator

Arm Description

4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel followed by surgery.

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage

Intervention Description

first-line anti-diabetic drug

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Other Intervention Name(s)

Doxorubicin, Cyclophosphamide, Paclitaxel

Intervention Description

First line neoadjuvant chemotherapy protocol

Primary Outcome Measure Information:

Title

Clinical benefit rate (Tumor size)

Description

Tumor size measured in calipers from baseline till the last cycle of neoadjuvant chemotherapy.

Time Frame

8 months

Secondary Outcome Measure Information:

Title

Pathological complete response

Description

The absence of residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.

Time Frame

8 months

Title

Number of participants with metformin-related adverse events

Description

Safety and tolerability of conventional anti-diabetic dose of metformin use in breast cancer patients.

Time Frame

8 months

Title

The effect of metformin on the quality of life of breast cancer patients

Description

Time Frame

8 months

Title

The effect of metformin on the quality of life of breast cancer patients

Description

A comparison between the metformin arm and the control arm in the change of quality of life from baseline using the European Organization for Research and Treatment of Cancer (EORTC QLQ BR45).Scoring of the EORTC QLQ-Br45 is performed according to the EORTC scoring manual. After the scoring procedures, all the responses to likert-scale items were linearly transformed to a 0-100 scale. Higher scores for functional scales and the global quality of life scale, indicate better quality of life, while for symptom scales and single items, a higher score indicates a higher severity of the symptoms and worse quality of life

Time Frame

8 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Female breast cancer patients

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Non-diabetic breast cancer patients, receiving neoadjuvant chemotherapy treatment. Female Age between 18- 65 years. Written informed consent. Exclusion Criteria: Known hypersensitivity reaction to Metformin. Intolerable Metformin GI complaints. Patients at risk of lactic acidosis. Diabetic breast cancer patients. Body Mass Index < 18.5 (underweight breast cancer patients). Renal impairment, eGFR <45 mL/min/1.73 m².

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hadeer M Ehab, M.Sc.

Phone

01020483388

hadeer.ehab7785@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed A El Berry, Ph.D.

Organizational Affiliation

Beni-Suef University

Official's Role

Study Director

Facility Information:

Facility Name

Beni-suef university

City

Banī Suwayf

ZIP/Postal Code

11815

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raghda R Sayed, Ph. D.

Phone

01010647666

Raghda.hussien@pharm.bsu.edu.eg

First Name & Middle Initial & Last Name & Degree

Hadeer M Ehab, MS.C.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Study protocol, safety and efficacy criteria, and statistical analysis.

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

sent by e-mail

Learn more about this trial

The Effect of Metformin on Breast Cancer Patients

We'll reach out to this number within 24 hrs