Breast Cancer
Conditions
Keywords
Metformin, Breast cancer
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.
Interventions
DRUGMetformin
first-line anti-diabetic drug
DRUGChemotherapy
First line neoadjuvant chemotherapy protocol
Sponsors
Ahram Canadian University
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is an open-labeled, parallel, randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical benefit rate (Tumor size) | 8 months | Tumor size measured in calipers from baseline till the last cycle of neoadjuvant chemotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response | 8 months | 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 | 8 months | 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 | 8 months | 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. |
Countries
Egypt
Contacts
Primary ContactHadeer M Ehab, M.Sc.
Outcome results
None listed