Fast-Her: Fasting Effects on Breast Cancer Treatment

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07624617
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Prolonged Fasting — BEHAVIORAL
    During prolonged fasting, participants will eat only once daily (dinner), with water, black coffee and tea permitted during fasting hours. Throughout all conditions, participants will continue their prescribed PI3K inhibitor dosing. All medications will be taken at standardized times to ensure consistent pharmacokinetic measurements.

Study Details

We hypothesize that promoting a fasting state will strengthen the anti-cancer effects of PI3K inhibitors in metastatic breast cancer (MBC) treatment. The primary objective of this study is to assess acceptability of prolonged fasting in this population.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Sequence A
    Normal eating → Washout → Prolonged fasting
  • Active Comparator: Sequence B
    Prolonged fasting → Washout → Normal eating

Primary Outcome Measure

Effect of plasma from fasting in patients on PI3K inhibitors on cell viability [ Time Frame: Week 2 of prolonged fasting ]

Central Contacts

Locations (1)

FacilityCityStateZIP
University of MinnesotaMinneapolisMinnesota55455

Find similar trials in Minneapolis, MN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Minnesota· Minneapolis, MN

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