NCT05990426 Alternate Day Fasting After Surgery for Patients Undergoing Chemotherapy
| NCT ID | NCT05990426 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Ovary Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-10-16 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jenna Marcus, MD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT05990426 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovary Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05990426 currently recruiting?
Yes, NCT05990426 is actively recruiting participants. Contact the research team at anne@northwestern.edu for enrollment information.
Where is the NCT05990426 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05990426 clinical trial?
NCT05990426 is sponsored by Northwestern University. The principal investigator is Jenna Marcus, MD at Northwestern University. The trial plans to enroll 30 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.