Fast-Her: Fasting Effects on Breast Cancer Treatment

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07624617
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Normal Eating — BEHAVIORAL
    During the normal eating intervention period, participants will follow their usual eating pattern. Participants will continue their prescribed PI3K inhibitor dosing, with medications taken at standardized times to ensure consistent pharmacokinetic measurements.
  • Prolonged Fasting — BEHAVIORAL
    During the prolonged fasting intervention period, participants will eat only once daily (dinner), with water, black coffee, and tea permitted during fasting hours. Participants will continue their prescribed PI3K inhibitor dosing, with medications 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

First listed
Jun 3, 2026
Start date
May 18, 2026
Status verified
Jul 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
    Participants randomized to Sequence A will complete a normal eating intervention period, followed by a washout period, followed by a prolonged fasting intervention period. Normal eating → Washout → Prolonged fasting
  • Active Comparator: Sequence B
    Participants randomized to Sequence B will complete a prolonged fasting intervention period, followed by a washout period, followed by a normal eating intervention period. 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)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Lisa Chow, MD, MS
[email protected]
612-625-8934

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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