Table 1.
Masked clinical studies completed after 2015
| STUDY | A Randomized Phase II, Double Blind Trial of Standard Chemotherapy With Metformin (vs. Placebo) in Women With Metastatic Breast Cancer Receiving First to Fourth Line Chemotherapy |
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| NCT NUMBER | NCT01310231 |
| STATUS | Completed |
| PARTICIPANTS | 40 participants, 18-75 years, sex: female |
| PERIOD | February 2011-March 2021 |
| INTERVENTION | Drug: Metformin |
| Metformin vs. placebo 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). | |
| CANCER TYPE | Metastatic breast cancer |
| OUTCOME | In this population metformin showed no significant effect on RR, PFS or OS. These results do not support the use of metformin with chemotherapy in non-diabetic MBC patients. |
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| STUDY | Phase II Study of Metformin in a Pre-prostatectomy Prostate Cancer Cohort |
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| NCT NUMBER | NCT01433913 |
| STATUS | Completed |
| PARTICIPANTS | 20 participants, sex: male |
| PERIOD | Sep 2011-May 2018 |
| INTERVENTION | Metformin hydrochloride vs. placebo both PO 4-12 weeks |
| CANCER TYPE | Adenocarcinoma of the Prostate: Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer |
| OUTCOME | No differences between the biomarker expression in the prostatectomy tissue or pre to postintervention changes in serum biomarkers (prostate-specific antigen, insulin, insulin-like growth factor-1, insulin-like growth factor binding protein 3, sex hormone-binding globulin, and testosterone) or tissue biomarkers of proliferation apoptosis, cell cycle regulation, and mTOR inhibition |
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| STUDY | A Phase II, Randomized, Placebo Controlled Study to Evaluate the Efficacy of the Combination of Gefitinib and Metformin in Patients With Locally Advanced and Metastatic Non-Small-Cell-Lung-Cancer |
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| NCT NUMBER | NCT01864681 |
| STATUS | Completed |
| PARTICIPANTS | 97 participants, 18-75 years, sex: all |
| PERIOD | May 2013-June 2018 |
| INTERVENTION | Gefitinib + metformin vs. gefitinb + placebo |
| CANCER TYPE | Treatment-naïve stage IIIB-IV with EGFR mutation in NSCLC |
| OUTCOME | incorporation of metformin into standard gefitinib therapy did not prolong PFS or OS in treatment naïve nondiabetic patients with EGFRm NSCLC, neither did it elicit an increase in response to gefitinib |
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| STUDY | Placebo Controlled Double Blind Crossover Trial of Metformin for Brain Repair in Children With Cranial-Spinal Radiation for MedulloblaStoma |
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| NCT NUMBER | NCT02040376 |
| STATUS | Completed |
| PARTICIPANTS | 30 participants, 5-21 years, sex: all |
| PERIOD | January 2014-May 2019 |
| INTERVENTION | Metformin and placebo doses will be 500 mg/m2 po daily given in 2 doses for one week and if there are no concerns increased to 1000 mg/m2 po daily given in 2 doses for the rest of the 12 week trial. The investigators will use the closest dose according to body surface area (250-500-750-1000) BID. |
| CANCER TYPE | Brain tumor |
| OUTCOME | Evidence that a clinical trial examining the effects of metformin on cognition and brain structure is feasible in long-term survivors of pediatric brain tumors and that metformin is safe to use and tolerable in this population |
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| STUDY | A Randomized, Phase II, Double-blind, Placebo-controlled, Multicenter, 2x2 Factorial Design Biomarker Tertiary Prevention Trial of Low-dose Aspirin and Metformin in Stage I-III Colorectal Cancer Patients. The ASAMET Trial |
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| NCT NUMBER | NCT03047837 |
| STATUS | Unknown |
| PARTICIPANTS | 180 participants, 18-80 years, sex: all |
| PERIOD | March 2017-February 2019 |
| INTERVENTION | Drug: Aspirin (ASA) + Metformin (MET) |
| Arm D (experimental arm) Treatment: active ASA + active MET Dose: 100 mg, 1 tablet daily + 850 mg, 1 tablet twice a day (BID) Duration: 12 months | |
| Drug: ASA | |
| Arm C (experimental arm) Treatment: active ASA + placebo MET Dose: 100 mg, 1 tablet daily + 1 tablet twice a day (BID) Duration: 12 months | |
| Drug: MET | |
| Arm B (experimental arm) Treatment: placebo ASA + active MET Dose: 1 tablet daily + 850 mg, 1 tablet twice a day (BID) Duration: 12 Arm A (control arm) Treatment: placebo ASA + placebo MET Doses: 1 tablet daily + 1 tablet twice a day (BID) Duration: 12 months | |
| CANCER TYPE | Stage I, II, or III primary colorectal cancer |
| OUTCOME | A favorable biomarker modulation by aspirin and metformin may provide important clues for a subsequent phase III adjuvant trial aimed at preventing second primary cancer, delaying recurrence and improving prognosis in patients with CRC. |
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| STUDY | Effect of Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells: A Randomized Double Blind Placebo-controlled Trial |
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| NCT NUMBER | NCT03618472 |
| STATUS | Completed |
| PARTICIPANTS | 50 participants, child, adult,older adult, sex: female |
| PERIOD | August 2018-January 2020 |
| INTERVENTION | Drug: Metformin Hydrochloride 850 MG |
| Regular strength metformin (850 mg/tab) vs. placebo | |
| CANCER TYPE | Endometrial cancer who undergoing complete surgical staging |
| OUTCOME | Metformin administration reduced Ki-67 expression and reduced grade in endometrial tumor when given for 4 weeks before hysterectomy |