The Effect of Metformin on Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

The Effect of Metformin on Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04559308
• Other study ID #: BSU
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2019
• Est. completion date: October 2020

Study information

• Verified date: September 2020
• Source: Beni-Suef University
• Contact: Hadeer M Ehab, M.Sc.
• Phone: 01020483388
• Email: hadeer.ehab7785[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Non-diabetic breast cancer patients, receiving neoadjuvant chemotherapy treatment.

2. Female Age between 18- 65 years.

3. Written informed consent.

Exclusion Criteria:

1. Known hypersensitivity reaction to Metformin.

2. Intolerable Metformin GI complaints.

3. Patients at risk of lactic acidosis.

4. Diabetic breast cancer patients.

5. Body Mass Index < 18.5 (underweight breast cancer patients).

6. Renal impairment, eGFR <45 mL/min/1.73 m².

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Metformin
first-line anti-diabetic drug
• Chemotherapy
First line neoadjuvant chemotherapy protocol

Locations

Country	Name	City	State
Egypt	Beni-suef university	Bani Suwayf

Sponsors (2)

Lead Sponsor	Collaborator
Beni-Suef University	Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical benefit rate (Tumor size)	Tumor size measured in calipers from baseline till the last cycle of neoadjuvant chemotherapy.	8 months
Secondary	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.	8 months
Secondary	Number of participants with metformin-related adverse events	Safety and tolerability of conventional anti-diabetic dose of metformin use in breast cancer patients.	8 months
Secondary	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.	8 months
Secondary	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	8 months