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Fast-Her: Fasting Effects on Breast Cancer Treatment

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
All sexes
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 long periods without food (fasting) are acceptable to adults with breast cancer that has spread who take capivasertib. Researchers also want to learn whether fasting may help the cancer treatment work better.

We hypothesize that promoting a fasting state will strengthen the anti-cancer effects of PI3K inhibitors in metastatic breast cancer (MBC) treatment. The primary objective of this study is to assess acceptability of prolonged fasting in this population.

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

Eligibility

Who can join

  • Age 18 or older, with breast cancer that has spread, confirmed by a tissue test.
  • Have gone through menopause or take medicine to stop the ovaries from working.
  • Take capivasertib: 2 tablets twice a day, 4 days a week, on the same treatment plan for at least 2 weeks.
  • Can do normal daily activities, with at most some limits on hard physical activity.
  • Have a body mass index (BMI), a measure of weight compared with height, of 25 or higher.
  • Can understand the study and agree to take part.
  • Willing to wear a continuous blood sugar monitor, track food in the mCC app, and make diet changes.
  • Have access to a smartphone or tablet to use the app.

Who can't join

  • Have type 1 diabetes or uncontrolled type 2 diabetes, with an HbA1c blood sugar test above 9.0%.
  • Have a history of very low blood sugar.
  • Have an eating disorder or any medical reason that makes fasting unsafe or not possible.
  • Are pregnant or breastfeeding.
  • Have serious stomach or bowel problems that affect how the body takes in nutrients from food.
  • Are taking part in another study that changes your diet.
  • Had major abnormal blood, liver, or kidney test results within 4 weeks before agreeing to join. Examples include hemoglobin below 10.0, platelets below 100, liver tests over twice the normal level, or creatinine above 1.5.

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

Official eligibility criteria

Inclusion Criteria: * Age ≥18 years * Histologically confirmed metastatic breast cancer * Menopausal or medically ovarian suppressed * Currently receiving capivasertib therapy (2 tablets twice daily, 4 days per week) * Stable on current capivasertib regimen for at least 2 weeks * an ECOG performance status of 0-1 * BMI ≥25kg/m2 * Able to provide informed consent * Willing to comply with study procedures including CGM wear, food tracking by mCC app and dietary modifications * Access to smartphone or tablet for mobile application use Exclusion Criteria: * Type 1 diabetes mellitus * Uncontrolled type 2 diabetes (HbA1c \>9.0%) * History of severe hypoglycemia * Eating disorders or contraindications to fasting * Pregnancy or breastfeeding * Significant gastrointestinal disorders affecting food absorption * Unable to fast for medical reasons * Concurrent participation in other dietary intervention studies * A history of significantly abnormal lab results within 4 weeks of consent date, such as hematologic (Hgb \< 10.0, platelets \< 100), hepatic (LFTs \> 2X nl), renal (Cr \> 1.5)

Study sites (1)

MN