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Clinical Trial Summary

This trial studies how well a diabetes prevention program (METFIT) works in reducing insulin resistance in stage I-III breast cancer survivors. METFIT program, a diet and lifestyle intervention, utilizes intermittent fasting to reduce insulin resistance in insulin resistant breast cancer survivors. Intermittent fasting has been shown to have benefits for patients undergoing cancer therapy by improving symptoms such as fatigue in breast cancer patients. Intermittent fasting has also shown potential for decreasing the risk of breast cancer coming back (recurrence). This trial is being done to determine if METFIT program can be successfully and effectively implemented to reduce insulin resistant in breast cancer survivors.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate the feasibility of the METFIT Program - a 6-month modified Diabetes Prevention Program (DPP)-based lifestyle modification intervention that utilizes intermittent fasting (IF) aimed at reducing insulin resistance (IR) in insulin resistant breast cancer survivors. SECONDARY OBJECTIVE: I. To estimate an effect size of the effectiveness of the METFIT Program in reducing IR in insulin resistant breast cancer survivors. OUTLINE: Patients undergo METFIT program for 16 sessions over 6 months. After completion of study treatment, patients are followed up for 40 days. ;


Study Design


Related Conditions & MeSH terms

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Breast Neoplasms
  • Early-Stage Breast Carcinoma
  • Insulin Resistance
  • Prognostic Stage I Breast Cancer AJCC v8
  • Prognostic Stage IA Breast Cancer AJCC v8
  • Prognostic Stage IB Breast Cancer AJCC v8
  • Prognostic Stage II Breast Cancer AJCC v8
  • Prognostic Stage IIA Breast Cancer AJCC v8
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8

NCT number NCT04560439
Study type Interventional
Source City of Hope Medical Center
Contact
Status Withdrawn
Phase N/A
Start date June 15, 2022
Completion date June 15, 2023

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