Alternate Day Fasting for Ovarian and Endometrial Cancer Chemotherapy
This study is looking at whether alternating fasting days with regular eating days, called the FAST Intervention, can help patients undergoing chemotherapy for ovarian, endometrial, or uterine cancer. You would fast for two consecutive days in the middle of the week surrounding your chemotherapy. The study aims to see how well participants follow this eating plan and how well they stick to their chemotherapy treatment. This study is for women aged 18 or older who have these cancers and are receiving chemotherapy after surgery. The study plans to enroll 30 participants, but its current status is unclear.
- Study design
- This is an interventional study with an unspecified phase, planning to enroll 30 participants. It is testing a behavioral intervention (alternate day fasting).
- What's involved
- Participants will follow an alternate day fasting schedule for one week around the start of each chemotherapy cycle. This includes fasting for two consecutive days in the middle of that week.
- Compensation
- Not stated in the trial record.
- Follow-up
- Compliance with the fasting intervention and treatment will be assessed at 18 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Alternate Day Fasting After Surgery for Patients Undergoing Chemotherapy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jenna Marcus, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
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What this trial measures
- Assessment Compliance18 weeks
Assessment compliance will be defined as missing no more than 75% of indicated Biosense measurement (i.e. no more than number of cycles × 7 measurements), which roughly corresponds to no more than 1 missed measurement per day of fasting period. The study will be considered feasible in terms of assessment compliance if at least 80% of all patients are compliant.
- Treatment Compliance18 weeks
Treatment compliance will be defined among patients on FAST as the proportion of measurements on fasting days when the patient is in ketosis (i.e., ACE score \> 5, or ketone levels of 0.5+ mmol/L). FAST treatment will be considered feasible in this patient population if \>80% of patients in the FAST arm are compliant with treatment.
- Fasting non-compliance18 weeks
Fasting non-compliance will be defined as anyone who began fasting but was not compliant with completing the 48-hour fast. Anyone who started ADF by following low caloric (equal or less than 400 cal) fast within 24 hours of C1D1 chemo regimen will be considered fasting compliant. Patients randomized to the intervention arm will be considered evaluable if they start their fasting diet regimen within 24 hours prior to starting day 1 of their first chemotherapy cycle (C1D1) and if they fast for three out of the four 24-hour long fasting windows within each of the six chemotherapy cycles. Patients randomized to the control arm will be considered evaluable if they started chemotherapy. Fasting non-compliance will be measured by number of participants meeting the above definition.