Clinical trial · Interventional
Alternate Day Fasting After Surgery for Patients Undergoing Chemotherapy
The Impact of Alternate Day Fasting After Surgery for Patients Undergoing chemoTherapy (FAST Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Ovary Cancer | — | UNRESOLVED | — |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FAST Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FAST Group
- description
- 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.
- interventionNames
- Behavioral: FAST Intervention
- type
- NO_INTERVENTION
- label
- Control Group
- description
- 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.
Primary outcomes (3)
- measure
- Assessment Compliance
- timeFrame
- 18 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available