Alternate Day Fasting After Surgery for Patients Undergoing Chemotherapy
FAST
The Impact of Alternate Day Fasting After Surgery for Patients Undergoing chemoTherapy (FAST Study)
1 other identifier
interventional
30
1 country
1
Brief Summary
Endometrial cancer is the most common gynecologic cancer and ovarian cancer is the most lethal. The management of both advanced cancers is a combination of chemotherapy and surgery. Standard of care chemotherapeutic treatment for uterine and ovarian cancers is toxic and severely disruptive to the patient's quality of life with the potential for devastating short and long-term side effects. The role of fasting and ketogenic diets has been evaluated in a mixed cancer population and previously shown to be safe. There is no data specifically addressing the impact of a fasting diet regimen on side effects of chemotherapy during treatment for ovarian and endometrial cancers in the front-line setting. The information gathered from this study will inform future trials about the role of time-restricted eating and its impact on side-effects associated with chemotherapy as well as its role in improvement of quality of life for women afflicted with these debilitating diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
October 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
March 24, 2026
March 1, 2026
2.8 years
April 14, 2023
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Assessment Compliance
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.
18 weeks
Treatment Compliance
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.
18 weeks
Fasting non-compliance
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.
18 weeks
Secondary Outcomes (3)
Adverse events and toxicity
18 weeks
Neuropathic Pain
18 weeks
Physical Function
18 weeks
Other Outcomes (8)
Cancer Related Fatigue
18 weeks
Molecular biomarker: Insulin
18 weeks
Molecular biomarker: insulin-like growth factor-1
18 weeks
- +5 more other outcomes
Study Arms (2)
FAST Group
EXPERIMENTALThe FAST intervention will consist of one week of alternate day fasting (ADF) using the sandwich model at the start of each cycle of chemotherapy, for a total of 6 weeks of ADF. Patients will be instructed on how and what they may consume on fasting days.
Control Group
NO INTERVENTIONParticipants in the control arm will be instructed to eat as desired throughout their entire chemotherapy treatment course. Control group participants will not receive any special study- related instructions or direction regarding food and drinks consumed during chemotherapy.
Interventions
Participants will alternate fasting days (FAST) with unrestricted eating (OFF, or "Feast") days, for one week surrounding the start of each chemotherapy cycle. The participants will fast for two consecutive days in the middle of the ADF week - the day prior to chemotherapy start date, and chemotherapy day 1 for each cycle. Participants will consume regular diet (OFF/Feast) during other days 5-18 of each cycle.
Eligibility Criteria
You may qualify if:
- Female; ≥ 18 years of age
- Confirmed or high suspicion for endometrial, ovarian, fallopian tube or primary peritoneal cancer, and are able and expecting to undergo adjuvant chemotherapy following hysterectomy for treatment of disease, as determined by their treating physician
- Fluent in spoken and written English
- Own a smart phone
- Have access to the internet to complete surveys
- ECOG status of 0 or 1
- Willingness to sign informed consent form
You may not qualify if:
- Patients who are not planning to undergo chemotherapy at Northwestern Medicine
- Patients engaged in shift work (i.e., those who work nights, 3rd shift)
- BMI of 50+ or those with a diagnosed eating disorder. Patients who take medications for blood glucose regulation (e.g. insulin), and/or require treatment with therapeutic doses of anticoagulants will be excluded.
- Patients who have been diagnosed with medication-dependent diabetes, recent myocardial infarction, stroke, pulmonary embolus, renal failure, or any condition that may preclude ability to tolerate a short-term fast will be excluded.
- Patients who take medications where conditions may be influenced in the presence of fasting (e.g. hypertension, electrolyte abnormalities, migraines) will be monitored by their treating physician for any necessary adjustments in these medications.
- Patients whose oncologist has not provided clearance for their participation
- Unable or unwilling to follow a diet regimen or participate in ketone measurements
- ECOG status greater than 1
- Patients who have undergone prior systemic therapy to treat a malignancy in the last 2 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jenna Marcus, MD
Northwestern University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 14, 2023
First Posted
August 14, 2023
Study Start
October 16, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
March 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share