Sponsor:
University of Miami
Code:
NCT06123988
Conditions
HER2-positive Breast Cancer
Advanced Breast Cancer
Eligibility Criteria
Sex: Female
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Prolonged Overnight Fasting
Moderate-Intensity Exercise
General Health Education Sessions
Brief summary:
Conditions
HER2-positive Breast Cancer
Advanced Breast Cancer
Study ID
NCT06123988
Start date
Sep 9, 2024
Status verified date
Aug, 2026
Completion date
Sep 30, 2029
Anticipated
Primary completion date
Sep 30, 2028
Anticipated
Eligibility Criteria
Sex: Female
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
260 participants
Anticipated
Allocation
Randomized
Intervention Model
Factorial
Primary purpose
Supportive Care
Arms
experimental: Prolonged Overnighting Fasting Alone (POF Alone) Group
active comparator: Exercise Alone (EXE Alone) Group
active comparator: Prolonged Overnight Fasting and Exercise (POF+EXE) Group
other: Attention Control (AC) Group
Interventions
Prolonged Overnight Fasting
Moderate-Intensity Exercise
General Health Education Sessions
Primary outcome measure
Central contacts
Locations
University of Miami
Recruiting
Miami, Florida, United States, 33136
Contacts
Principal Investigator:
Tracy E Crane, PhD, RDN
Dana-Farber Cancer Institute
Recruiting
Boston, Massachusetts, United States, 02215
Contacts
Principal Investigator:
Christina Dieli-Conwright, PhD, MPI
Sponsor
University of Miami
Last update posted
Aug 26, 2026
Last verified
Aug, 2026
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-26.