๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Age โฅ18 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 โฅ25kg/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)
๐
What it tests
- Normal Eating
- Prolonged Fasting
University of Minnesota
Minneapolis, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.