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Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer

Sponsored by University of Miami

About this study

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.

Where this study is enrolling (3)

Who can participate

Inclusion criteria

  • ✓1. Women
  • ✓2. Able to provide written informed consent
  • ✓3. Able to speak, read, and understand English or Spanish
  • ✓4. Postmenopausal (including concurrent use of ovarian suppression)
  • ✓5. Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- or HER-2+ metastatic or locally advanced unresectable breast cancer
  • ✓6. 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.
  • ✓7. 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
  • ✓8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months
  • ✓9. 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
  • ✓10. Approval from a medical oncology provider to participate.

Exclusion criteria

  • ✕1. Unable to provide consent
  • ✕2. Unable to read or understand English or Spanish
  • ✕3. Dependent on supplemental oxygen
  • ✕4. Unstable cardiac disease
  • ✕5. Insulin-dependent diabetes
  • ✕6. Unable to walk 2 blocks without assistance (excluding canes)
  • ✕7. Regularly maintaining a shiftwork schedule, i.e. working evening shifts, night shifts, or rotating shifts in the last 3 months
  • ✕8. History of a clinical eating disorder
  • ✕9. Unstable bone metastases
  • ✕10. 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.
  • ✕11. Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.