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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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether four care programs, using longer overnight fasting, exercise, or both, can reduce fatigue (feeling very tired). It is for women with advanced breast cancer that responds to hormones who take a CDK4/6 inhibitor with hormone therapy, with or without a PI3K or AKT inhibitor.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women who have gone through menopause or take medicine to stop their ovaries from working.
  • Able to give written consent and speak, read, and understand English or Spanish.
  • Breast cancer that responds to estrogen or progesterone and has spread to other body parts or nearby areas and cannot be removed by surgery. Either HER2-positive or HER2-negative cancer is allowed.
  • Started hormone therapy with a CDK4/6 inhibitor within the past 90 days. HER2-targeted treatment or a PI3K or AKT inhibitor may also be used. If switching CDK4/6 drugs because of side effects or insurance, enrollment must be within 90 days of starting the new drug.
  • In the past 3 months, did not exceed 90 minutes of moderate exercise or 45 minutes of hard exercise per week at least half the time.
  • In the past 3 months, did not regularly do strength training 2 or more days a week.
  • In the past 3 months, did not fast (go without eating) for 12 or more hours overnight at least half the time.
  • Have approval from a cancer care provider to join.

Who can't join

  • Unable to give consent or read or understand English or Spanish.
  • Need extra oxygen, have heart disease that is not stable, or have diabetes that requires insulin.
  • Cannot walk 2 blocks without help. Using a cane is allowed.
  • Regularly worked evening, night, or rotating shifts in the past 3 months.
  • Have a history of a diagnosed eating disorder.
  • Have cancer that has spread to the bones and is not stable.
  • Started the listed combination of cancer drugs more than 90 days ago.
  • Have a serious physical or mental health condition, or take medicines, that would prevent taking part in the study program.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (3)

AZ

FL

MA