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OpenTrials
Completed

NCT Number: NCT00909506

Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Weight loss

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 28, 2009
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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