Diabetes Prevention Program (METFIT) in Reducing Insulin Resistance in Stage I-III Breast Cancer Survivors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage IIA 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
- Early Stage Breast Carcinoma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Only males
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. SEC...
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.
Tracking Information
- NCT #
- NCT04560439
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Raynald Samoa City of Hope Comprehensive Cancer Center
Get Well Soon