Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diabetes Prevention Program (METFIT) in Reducing Insulin Resistance in Stage I-III Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04560439
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : February 17, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
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 Early-Stage Breast Carcinoma 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 Dietary Supplement: Dietary Intervention Not Applicable

Detailed 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: METFIT Program - A Pilot Study Exploring the Feasibility of a Diabetes Prevention Program (DPP)-Based Lifestyle Modification Intervention to Reduce Insulin Resistance in Breast Cancer Survivors
Estimated Study Start Date : June 15, 2022
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : June 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment (METFIT program)
Patients undergo METFIT program for 16 sessions over 6 months.
 Dietary Supplement: Dietary Intervention
Undergo METFIT program
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Fidelity [ Time Frame: Up to week 8 of intervention ]
    The percentage of the cohort that has concordance of glucose trends with diet log to assess adherence to intermittent fasting regimen by week 8 of the intervention. Descriptive quantitative statistics will be used to report fidelity.

  2. Retention [ Time Frame: Up to 6 months ]
    Defined as the rate of participants that complete the intervention and post intervention assessments. Attendance percentage of blood draws and body measurements at both time points. Descriptive quantitative statistics will be used to report retention.


Secondary Outcome Measures :
  1. Change in insulin resistance (IR) [ Time Frame: Baseline to 6 months ]
    Assessed by Homeostatic Model Assessment of Insulin Resistance [HOMA-IR]). The HOMA-IR scores of each subject will be compared to their HOMA-IR scores after the intervention using a paired t-test analysis.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women who have been treated definitively for early stage breast cancer (I-III) and are 60-180 days from completion of chemotherapy, radiation and surgery regardless of hormonal status
  • Demonstrated at least a 10% weight gain since being diagnosed with breast cancer
  • Demonstrated IR by having a Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score of >= 2.0

  • Demonstrated IR manifested by meeting criteria for metabolic equivalent (MetS) as defined by modified criteria of the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) (2005 version) and the World Health Organization (WHO) which includes:

    • Dysregulation of glucose homeostasis demonstrated by a glycosylated hemoglobin (HbA1c) >= 6.5%; OR fasting plasma glucose >= 126 mg/dl (7.0 mmol/L) OR random plasma glucose >= 200 mg/dL (11.1 mmol/L)

    • Plus two of any of the following:

      • Waist circumference in men >= 40 inches and in women >= 35 inches
      • Elevated triglycerides >= 150 mg/dL
      • Low high-density lipoprotein (HDL) cholesterol in men < 40 mg /dL and in women < 50 mg/dL or taking statin medication
      • Elevated blood pressure defined by a systolic pressure >= 130 of a diastolic pressure >= 85 mm Hg or taking anti-hypertensive medication
      • Elevated fasting glucose >= 110 mg/dL
  • Non-smoker (last use 6 months prior to enrollment into the study)
  • Documented informed consent of the participant and/or legally authorized representative
  • Willingness to make substantial changes in their dietary and physical activity behavior
  • Willingness to attend at 70% of the intervention sessions and 100% of the blood draws
  • The effects of IF on the developing fetus of breast cancer survivors are unknown. For this reason, women of child bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating in the trial, should inform her treating physician immediately
  • Willingness to weigh themselves weekly
  • Willingness to wear a subcutaneous continuous glucose monitor
  • Access to an electronic virtual teleconferencing device and capacity to utilize electronic teleconference technology

Exclusion Criteria:

  • Use of any medication to treat diabetes mellitus
  • Type 2 diabetes
  • History of myocardial infarction or congestive heart failure within the previous 12 months prior to being screened for participation in the study
  • Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity

  • Unstable cardiac disease as defined by one of the following:

    • Cardiac events such as myocardial infarction (MI) within the past 6 months
    • New York Heart Association (NYHA) heart failure class III-IV
    • Uncontrolled atrial fibrillation or hypertension
  • History of vascular disease (e.g. deep vein thrombosis, stroke) within six months of starting the intervention
  • Clinically significant uncontrolled illness
  • Women who are pregnant or breastfeeding
  • Any other condition (including psychosocial condition) that would, in the investigator's judgment, contraindicates the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Any other condition that would confound study results
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560439


Locations
Layout table for location information
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Raynald Samoa    626-256-4673 ext 85208    rsamoa@coh.org   
Principal Investigator: Raynald Samoa         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Raynald Samoa City of Hope Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT04560439    
Other Study ID Numbers: 19447
NCI-2020-04551 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19447 ( Other Identifier: City of Hope Comprehensive Cancer Center )
P30CA033572 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Insulin Resistance
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases