Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators hypothesize that adjuvant metformin use in breast cancer patients with overweight or pre-diabetes mellitus (DM) may improve their body condition including weight loss.
In this study, the investigators aim to test the efficacy and safety of adjuvant metformin for operable breast cancer patients with overweight or pre-DM.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Metformin 500 mg/d | Active Comparator | Metformin 500 mg/d |
|
| Metformin 1000 mg/d | Active Comparator | Metformin 1000 mg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Control: Receive placebo pill once every evening on 1~2 weeks. Receive placebo pill in every morning and evening on 3~24 weeks (twice a day). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wonshik Han, M.D., Ph.D. | Department of General Surgery, Seoul National University College of Medicine & Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Metformin | Drug | Metformin 500 mg/d: Receive oral metformin 500 mg dose once daily on 1~2 weeks. Receive placebo pill in every morning and oral metformin 500 mg in every evening on 3~24 weeks. |
|
| Metformin | Drug | Metformin 1000 mg/d : Receive oral metformin 500 mg dose once daily on 1~2 weeks. (Dose-escalate) Receive oral metformin 500 mg in every morning and evening on 3~24 weeks (metformin 500 mg * twice a day = 1000 mg per day). |
|
| D017437 |
| Skin and Connective Tissue Diseases |