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Anatomic Stage I Breast Cancer AJCC v8NCT04560439

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

A study testing Dietary Intervention in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by City of Hope Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Dietary Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
15 Jun 2022to 15 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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)

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary InterventionDietary supplement

    Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions

    Undergo METFIT program

Study groups in NCT04560439
Study groupRoleWhat they receive
Treatment (METFIT program)ExperimentalPatients undergo METFIT program for 16 sessions over 6 months.
Receives: Dietary Supplement: Dietary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fidelity

    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.

    Measured: Up to week 8 of intervention

  2. Retention

    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.

    Measured: Up to 6 months

Secondary outcomes (1)

  1. Change in insulin resistance (IR)

    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.

    Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2020
  2. Study start15 Jun 2022 (estimated)
  3. Primary completion15 Jun 2023 (estimated)
  4. Study completion15 Jun 2023 (estimated)

Why it stopped: Funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04560439
Sponsor's protocol ID
19447
Other IDs
NCI-2020-04551, 19447, P30CA033572
Status last verified
Jun 2022
First submitted
10 Sep 2020
Last updated
9 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Intervention in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by City of Hope Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fidelity (time frame: Up to week 8 of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04560439.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.

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