Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2019-06-01
2020-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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metformin arm
4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel+ Metformin (1000 mg twice daily) followed by surgery.
Metformin
first-line anti-diabetic drug
Chemotherapy
First line neoadjuvant chemotherapy protocol
control arm
4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel followed by surgery.
Chemotherapy
First line neoadjuvant chemotherapy protocol
Interventions
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Metformin
first-line anti-diabetic drug
Chemotherapy
First line neoadjuvant chemotherapy protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Female Age between 18- 65 years.
3. Written informed consent.
Exclusion Criteria
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.
18 Years
65 Years
FEMALE
No
Sponsors
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Ahram Canadian University
OTHER
Beni-Suef University
OTHER
Responsible Party
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Hadeer Mohamed Ehab
Clinical Pharmacy Researcher
Principal Investigators
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Ahmed A El Berry, Ph.D.
Role: STUDY_DIRECTOR
Beni-Suef University
Locations
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Beni-suef university
Banī Suwayf, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BSU
Identifier Type: -
Identifier Source: org_study_id
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