RECRUITING Not applicable ClinicalTrials.gov

Alternate Day Fasting After Surgery for Patients Undergoing Chemotherapy

Sponsor: Northwestern University • ClinicalTrials.gov ID: NCT05990426

Registry updated: 2026-10-15

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Description

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.

Interventions

FAST Intervention (Behavioral)
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

Inclusion Criteria: 1. Female; ≥ 18 years of age 2. 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 3. Fluent in spoken and written English 4. Own a smart phone 5. Have access to the internet to complete surveys 6. ECOG status of 0 or 1 7. Willingness to sign informed consent form Exclusion Criteria: 1. Patients who are not planning to undergo chemotherapy at Northwestern Medicine 2. Patients engaged in shift work (i.e., those who work nights, 3rd shift) 3. 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. 4. 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. 5. 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. 6. Patients whose oncologist has not provided clearance for their participation 7. Unable or unwilling to follow a diet regimen or participate in ketone measurements 8. ECOG status greater than 1 9. Patients who have undergone prior systemic therapy to treat a malignancy in the last 2 years.

Conditions

Ovary Cancer Endometrial Cancer Uterine Cancer

Locations

Northwestern Memorial Hospital — Chicago, Illinois, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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