Fasting and Exercise for Women with Advanced Breast Cancer

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

Recruiting N/A Interventional Study
HER2-positive Breast Cancer Advanced Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Supportive Care
Participants needed
260 (estimated)
Sponsor
University of Miami · Other
Who this trial is looking for

This trial is looking for women with advanced breast cancer to test if fasting, exercise, or health education can help reduce fatigue. Participants will be grouped into different programs to see which one is best.

Are You a Good Fit for This Trial?
Must be taking CDK4/6 inhibitor
Rules you out Severe medical conditionSevere psychiatric condition

You may be able to join if

  • I am a woman
  • I can give written consent
  • I speak and understand English or Spanish
  • I am postmenopausal
  • I have advanced breast cancer that is hormone receptor positive
  • I started treatment with a CDK4/6 inhibitor within the last 90 days
  • I haven't regularly exercised or fasted over the last 3 months
  • My doctor approves my participation

You may not be able to join if

  • I cannot provide consent
  • I cannot read or understand English or Spanish
  • I am oxygen dependent
  • I have unstable heart disease
  • I have insulin-dependent diabetes
  • I can't walk 2 blocks without help
  • I have a history of eating disorders
  • I have unstable bone metastases

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Check Your Eligibility
About This Trial
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., palbocicl…
Trial Locations
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Eligibility Criteria
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…
Contacts

Grey Freylersythe, BS

(305) 243-9832

g.freylersythe@med.miami.edu

CONTACT

Tracy E Crane, PhD, RDN

(305) 243-8255

tecrane@med.miami.edu

CONTACT