Recruiting

Alternate Day Fasting

Sponsor:

Northwestern University

Code:

NCT05990426

Conditions

Ovary Cancer

Endometrial Cancer

Uterine Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FAST Intervention

Study Details

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.

Conditions

Ovary Cancer

Endometrial Cancer

Uterine Cancer

Study ID

NCT05990426

Start date

Oct 16, 2023

Status verified date

Mar, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: FAST Group

The 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.

no intervention: Control Group

Participants 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

FAST Intervention

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.

Primary outcome measure

  • Assessment Compliance [ Time Frame: 18 weeks ]
  • Treatment Compliance [ Time Frame: 18 weeks ]
  • Fasting non-compliance [ Time Frame: 18 weeks ]

Central Contacts and Locations

Central contacts

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Anne Grace, PhD

312-503-4165

Principal Investigator:

Jenna Marcus, MD

More Information

Sponsor

Northwestern University

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

  • chemotherapy
  • peripheral neuropathy
  • intermittent fasting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-03-24.