Fasting regimen for women undergoing chemotherapy after surgery for gynecologic cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of alternate day fasting on women undergoing chemotherapy for ovarian and endometrial cancers. It aims to assess whether a fasting diet can mitigate the side effects of chemotherapy and improve the quality of life for patients. Participants will be women aged 18 and older who are expected to undergo adjuvant chemotherapy following surgery. The study will gather data on the impact of time-restricted eating on chemotherapy-related side effects and overall well-being.

Why it matters

Who can join: the full rules

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.

Where it's running

• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Jenna Marcus, MD — Northwestern University
• Study coordinator: Anne Grace, PhD
• Email: anne@northwestern.edu
• Phone: 312-503-4165

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.