Fasting regimen for women undergoing chemotherapy after surgery for gynecologic cancers
The Impact of Alternate Day Fasting After Surgery for Patients Undergoing chemoTherapy (FAST Study)
This study is testing if an alternate day fasting diet can help women with ovarian and endometrial cancers feel better during chemotherapy and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05990426 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with confirmed or suspected endometrial or ovarian cancer who are planning to undergo chemotherapy.
Not a fit: Patients who are not planning to undergo chemotherapy or have certain medical conditions, such as severe obesity or eating disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the side effects of chemotherapy and enhance the quality of life for patients with gynecologic cancers.
How similar studies have performed: While fasting and ketogenic diets have shown promise in mixed cancer populations, this specific approach for gynecologic cancers is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.