Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT00909506
Eligibility Criteria:
Inclusion Criteria:
* Operable Breast cancer patients with BMI ≥ 23 or 100 ≤ FBS \< 126
* From 6 month to 2 years since breast cancer operation and at least 4 weeks since chemotherapy or radiotherapy
* No drug use except Tamoxifen
* Normal OTPT \& Serum creatinine (\<=ULN)
* ECOG performance status 0-2 or Karnofsky PS 60-100%
* Life expectancy \> 12
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L
* Pregnancy(-) \& without plan for pregnancy
* Sign a written informed consent form
Exclusion Criteria:
* Type I or II DM or concurrent use of DM control agents
* Prior use of Metformin
* Hypoglycemia (FBS\< 70 with clinical symptom)
* Concurrent investigational or commercial agents
* Other diet or drug intervention for weight loss
* Concurrent use of steroid
* Abnormal liver and/or renal function
* Symptomatic congestive heart failure / Cardiac arrhythmia / Angina pectoris
* Ongoing or active infection
* lactic acidosis
* Pregnancy or ongoing breast feeding
* Anorexia, bulimia, nausea due to other disease for longer than 1 month
* Allergies or allergic reactions attributed to oral medications
* Inability to swallow or digest oral medications
* Physical or psychiatric illness that would limit compliance with study protocol
* Participants in other clinical trial
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Study:
NCT00909506
Study Brief:
Protocol Section:
NCT00909506