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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Female; ≥ 18 years of age

• 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

• Fluent in spoken and written English

• Own a smart phone

• Have access to the internet to complete surveys

• ECOG status of 0 or 1

• Willingness to sign informed consent form

Locations
United States
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Contact Information
Primary
Anne Grace, PhD
anne@northwestern.edu
312-503-4165
Backup
Juan Avitia, BS
juan.avitia1@nm.org
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2026-08
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov