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NCT06123988 · ClinicalTrials.gov registry record · NA
Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer
A NA study of HER2-positive Breast Cancer and Advanced Breast Cancer, sponsored by University of Miami.
- Recruiting
- Registry status
- NA
- Development phase
- 260
- Enrollment target
- 3
- Study locations
NCT06123988: Recruiting NA study of HER2-positive Breast Cancer and Advanced Breast Cancer, sponsored by University of Miami.
NCT06123988 is a NA study of HER2-positive Breast Cancer and Advanced Breast Cancer that is actively recruiting participants, run by University of Miami. The registered enrollment target is 260 participants, above the 231-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (13% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06123988, a NA study of HER2-positive Breast Cancer and Advanced Breast Cancer, is actively recruiting participants, sponsored by University of Miami.
- RECRUITING
- Registry status
- NA
- Development phase
- 260 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to test if four different programs (prolonged overnighting fasting alone, exercise alone, a combination of prolonged overnight fasting and exercise, or general health education sessions alone) can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a cyclin-dependent kinases-4 and 6 (CDK4/6) inhibitor (e.g., palbociclib, ribociclib, or abemaciclib), with or without HER2-directed therapy (e.g., trastuzumab ± pertuzumab), or in combination with both a CDK4/6 inhibitor and a PI3K inhibitor, within the past 90 days.
Primary Outcome
Change in self-reported cancer-related fatigue as measured by participant scores on the European Organisation For Research And Treatment Of Cancer (EORTC) core quality of life questionnaire (QLQ) (EORTC QLQ-C30). The EORTC QLQ-C30 is a self-administered, 30-item questionnaire used to measure cancer patients' health-related quality of life. The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Ve
Conditions Studied
Interventions
- BEHAVIORAL Prolonged Overnight Fasting
- BEHAVIORAL Moderate-Intensity Exercise
- BEHAVIORAL General Health Education Sessions
Study Locations (3)
Arizona
- Arizona State University - Phoenix
Florida
- University of Miami - Miami
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2024-09-09 |
| Est. Completion | 2029-09-30 |
| Phase | NA |
What NCT06123988 shows while recruiting
NCT06123988 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 231-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (13% higher).
The record links to 2 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Prolonged Overnight Fasting is the first listed.
NCT06123988 reports a single indexed study location in Arizona, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06123988 about?
NCT06123988 is a clinical study titled "Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer". The purpose of this study is to test if four different programs (prolonged overnighting fasting alone, exercise alone, a combination of prolonged overnight fasting and exercise, or general health education sessions alone) can reduce fatigue in women with advanced or metastatic breast cancer who are ...
What is the current status of trial NCT06123988?
This trial is currently recruiting. It is a NA study. The enrollment target is 260 participants. The study started on 2024-09-09. Estimated completion is 2029-09-30.
What conditions does trial NCT06123988 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer, Advanced Breast Cancer.
What interventions are being tested in trial NCT06123988?
The interventions under investigation include: Prolonged Overnight Fasting (BEHAVIORAL), Moderate-Intensity Exercise (BEHAVIORAL), General Health Education Sessions (BEHAVIORAL).
Who is sponsoring clinical trial NCT06123988?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06123988 being conducted?
This trial has 3 study locations across Arizona, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-positive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06123988's enrollment target sits among peer trials
260 10th of 58 higher than 49 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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