Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06106477
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intermittent Fasting — BEHAVIORAL
    Participants will be asked to adhere to a six-month intermittent fasting intervention, a daily-recurring dietary plan consisting of: * An approximately fourteen-hour nightly fasting period that is followed by * An approximately ten-hour eating period with their last meal of the day occurring between 17:00 (5:00 PM) and 21:00 (9:00 PM).

Study Details

This single-arm study is designed to test the hypothesis that a six-month intermittent fasting (IF) intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant endocrine therapy (AET).

Key Dates

Start date
Jul 19, 2024
Status verified
Aug 2025
Primary completion
Jul 15, 2026
Completion
Jul 15, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intermittent Fasting
    Enrolled subjects are expected to start the study intervention after completion of definitive therapy and within three months of starting AET.

Primary Outcome Measure

Subject adherence to the intermittent fasting schedule. [ Time Frame: Six months ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
Sailaja Kamaraju, MD
[email protected]
414-805-4600
Sailaja Kamaraju, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Milwaukee, WI

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Froedtert Hospital & the Medical College of Wisconsin· Milwaukee, WI

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