RECRUITING

Alternate Day Fasting After Surgery for Patients Undergoing Chemotherapy

Conditions

Ovary Cancer Endometrial Cancer Uterine Cancer chemotherapy peripheral neuropathy intermittent fasting

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

The Impact of Alternate Day Fasting After Surgery for Patients Undergoing chemoTherapy (FAST Study)

Quick Facts

Study Start:2023-10-16

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05990426

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Anne Grace, PhD

CONTACT

312-503-4165

anne@northwestern.edu

Juan Avitia, BS

CONTACT

juan.avitia1@nm.org

Principal Investigator

Jenna Marcus, MD

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

Northwestern Memorial Hospital

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: Northwestern University

Jenna Marcus, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-16

Study Completion Date2026-08

Study Record Updates

Study Start Date2023-10-16

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

chemotherapy
peripheral neuropathy
intermittent fasting

Additional Relevant MeSH Terms

Ovary Cancer
Endometrial Cancer
Uterine Cancer