Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer
Recruiting · NCT06123988 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
General Health Education SessionsModerate-Intensity ExerciseProlonged Overnight Fasting
What this trial is about
The purpose of this study is to test whether four different supportive care programs can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) alongwith endocrine therapy with or without a PI3K or AKT inhibitor.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Women
- Able to provide written informed consent
- Able to speak, read, and understand English or Spanish
- Postmenopausal (including concurrent use of ovarian suppression)
- Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- or HER-2+ metastatic or locally advanced unresectable breast cancer
- Initiation of endocrine therapy in combination with a CDK4/6 inhibitor (e.g., palbociclib, ribociclib, or abemaciclib), with or without hormone estrogen receptor-2 (HER2)-directed therapy (e.g., trastuzumab ± pertuzumab), or in combination with both a CDK4/6 inhibitor and a Phosphoinositide 3-kinase (PI3K) or Protein kinase B (AKT) inhibitor, within the past 90 days.
- a) Participants who switch from one CDK4/6 inhibitor to another due to toxicity or insurance constraints remain eligible, provided enrollment occurs within 90 days of initiating the subsequent CDK4/6 inhibitor in the metastatic or locally advanced setting.
- Having not consistently (not equal to or more than 50% of the time) engaged in more than 90 minutes of moderate or 45 minutes of vigorous physical activity per week over the past 3 months
- Having not consistently engaged in resistance training 2 or more days per week over the past 3 months
- Having not consistently (not equal to or more than 50% of the time) engaged in structured fasting (i.e., not regularly fasting for ≥12hr/night) for the past 3 months
- Approval from a medical oncology provider to participate.
Exclusion criteria
- Unable to provide consent
- Unable to read or understand English or Spanish
- Dependent on supplemental oxygen
- Unstable cardiac disease
- Insulin-dependent diabetes
- Unable to walk 2 blocks without assistance (excluding canes)
- Regularly maintaining a shiftwork schedule, i.e. working evening shifts, night shifts, or rotating shifts in the last 3 months
- History of a clinical eating disorder
- Unstable bone metastases
- More than 90 days since initiation of endocrine therapy in combination with 1) a CDK4/6 inhibitor, with or without HER2-directed therapy, or 2) a CDK 4/6 inhibitor in combination with a PI3K/AKT inhibitor, in the metastatic or locally advanced.
- Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention.
Where it is running
3 locations listed across 3 US states.
- Arizona State University - Phoenix, Arizona, United States
- University of Miami - Miami, Florida, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States