An interventional study of FAST Intervention in Ovary Cancer, Endometrial Cancer and Uterine Cancer, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Northwestern University · Not applicable, Interventional, and Supportive care
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.
Uterine cancer is the most common gynecologic cancer diagnosed in women and the fourth most common cancer to be diagnosed in females with an estimated 65,950 cases that will be diagnosed this year in the United States. Although not as common as endometrial cancer, ovarian cancer is the fifth most lethal cancer in females with an estimated 19,880 cases diagnosed this year. Standard of care treatments such as chemotherapy are toxic and severely disruptive to the patient's quality of life with potential short and long-term devastating side effects. The management of advanced gynecologic cancers of the uterus and ovary is often with a combination of surgery and chemotherapy in medically stable patients. The sequence of treatment is dependent on the patient's medical conditions, disease distribution and likelihood of complete resection at the time of surgery. Even when surgery results in complete resection in those with advanced disease, systemic treatment with chemotherapy is frequently prescribed. First line treatment for advanced uterine and ovarian cancer with carboplatin and paclitaxel has been shown to be tolerable and effective. However, these drugs often have a wide range of toxic side effects associated with their administration and may require treatment delays or dosing adjustments for patients to complete the prescribed treatment. In addition to hematologic toxicity and metabolic derangements, systemic chemotherapy often has debilitating side effects associated with treatment such as peripheral neuropathy. Supportive medications for side effects associated with chemotherapy are often given to patients for self-administration at home to combat symptoms in the several days following infusion, but there are limited interventions available to help patients further and with long term toxicities. New strategies are needed to help patients better tolerate these taxing side effects to improve patient outcomes and quality of life.
The effect of diet in rodents is well studied and has shown restriction of calories results in improved lifespan, and delayed onset of age associated diseases such as hypertension, diabetes, autoimmune conditions and cancer. With respect to chemotherapy administration in humans, the concept of differential stress resistance has been published and demonstrates protection of normal cells during periods of fasting where, conversely cancer cells become more susceptible to chemotherapy. This has been applied in few human studies where the impact of diet on cancer treatment was evaluated across a variety of cancer diagnoses and was found be safe and without worsening side effects from treatment. In time-restricted eating, participants eat within a specific time (eating window) and fast for the rest of the day (fasting window) every day.
There are several definitions and descriptions of intermittent fasting (IF). There are 2 components to the fasting regimen: (1) the duration of the actual time fasting (hours) and (2) the schedule of the periods of fasting (days, weeks, months). Alternate day fasting (ADF) is defined as 24-hour periods of fasting alternating with 24-hour periods of eating/feasting. This can be modified and extend the fasting window up to periods of 72 hours as previously studied in cancer populations and has been feasible and tolerable. The fasting schedule is then either prolonged over periods of weeks or short-term over a period of days. Prolonged fasting has been used for caloric restriction and long-term weight loss, which is not ideal in a cancer population. We chose this short-term, modified alternate day fasting regimen to both limit weight loss and center the prescribed "fasting window" around administration of chemotherapy when we expect to see the largest benefit in terms of reduction of toxic chemotherapy-related side effects. In addition, food intake rapidly initiates a cascade of biochemical responses to process the incoming nutrients. In contrast, during fasting, the body mobilizes stored energy. Specifically, the mechanistic target of rapamycin complexes-1 and -2 (mTORC1 and mTORC2) are regulated by nutrient availability, and loss of mTOR signaling partially mediates the cellular effects of fasting interventions on cancer cells. In muscles, caloric intake activates mTOR signaling within 30 minutes of eating to yield an anabolic state, with peak mTORC1 activity at approximately 60-90 minutes. Subsequently, mTORC1 is gradually deactivated. Approximately 12-16 hours after food absorption, a metabolic switch is activated in which the primary source of energy shifts from glucose to fat and ketones. This metabolic switch, mediated by decreased mTOR signaling, is key for prolonged fasting (>\~16 hours) to be effective. Using ADF helps in initiating this metabolic switch several times before, during, and after chemotherapy and might increase the benefit of fasting. Another form of intermittent fasting is alternate-day fasting (ADF) which is defined as alternating between fasting day (0-25% of energy needs) and feasting day (eating as desired). Preliminary studies in ovarian cancer patients suggest that restricting energy and/or protein intake at the time of chemotherapy might help reduce chemotherapy-related side effects and improve patients' quality of life. Of particular concern in an ovarian cancer patient population is malnutrition and the contribution of a time restricted eating intervention on weight loss. Intermittent fasting and, more specifically, short-term fasting, has been used in several pilot studies and has shown beneficial effects among the gynecologic and breast cancer populations without weight loss or serious adverse events. There are few published studies which look at multiple cancer types in each study and evaluate patients at variable timepoints in their treatment (ie. Initial vs recurrent disease). The effect of alternate day fasting during front-line chemotherapy on chemotherapy-associated side effects and quality of life has never been tested. Here we propose a dietary strategy in gynecologic cancer patients undergoing their first line of treatment to study the impact of intermittent fasting in patients with uterine and ovarian cancers.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's planned enrollment of 30 is below the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: FAST Intervention
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.
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.
Also known as: Alternate Days Fasting Dietary Regimen
Assessment Compliance
Assessment compliance will be defined as missing no more than 75% of indicated Biosense measurement (i.e. no more than number of cycles × 7 measurements), which roughly corresponds to no more than 1 missed measurement per day of fasting period. The study will be considered feasible in terms of assessment compliance if at least 80% of all patients are compliant.
Time frame: 18 weeks
Treatment Compliance
Treatment compliance will be defined among patients on FAST as the proportion of measurements on fasting days when the patient is in ketosis (i.e., ACE score \> 5, or ketone levels of 0.5+ mmol/L). FAST treatment will be considered feasible in this patient population if \>80% of patients in the FAST arm are compliant with treatment.
Time frame: 18 weeks
Fasting non-compliance
Fasting non-compliance will be defined as anyone who began fasting but was not compliant with completing the 48-hour fast. Anyone who started ADF by following low caloric (equal or less than 400 cal) fast within 24 hours of C1D1 chemo regimen will be considered fasting compliant. Patients randomized to the intervention arm will be considered evaluable if they start their fasting diet regimen within 24 hours prior to starting day 1 of their first chemotherapy cycle (C1D1) and if they fast for three out of the four 24-hour long fasting windows within each of the six chemotherapy cycles. Patients randomized to the control arm will be considered evaluable if they started chemotherapy. Fasting non-compliance will be measured by number of participants meeting the above definition.
Time frame: 18 weeks
Adverse events and toxicity
Assess differences in expected toxicities associated with chemotherapy administration using Common Terminology Criteria for Adverse Events (CTCAE) Safety definition: we expect toxicity profile to be similar between the two arms, although formally testing the Adverse Event (AE) rates will be underpowered. After every 6 patients have been randomized (4+2 in the two arms), the PI will review cumulative toxicity data by arm. If a high proportion of patients in the AFT arm has a particular type of AE which has substantially lower prevalence or is not observed in the non-AFT arm, enrollment may be paused to further evaluate the reasons and supportive care of these unexpected AE's. Patients will be considered evaluable for safety if they started any of the study treatments (ADF and chemotherapy).
Time frame: 18 weeks
Neuropathic Pain
Assess differences in Patient Reported Outcomes (PROs) utilizing Patient Reported Outcomes Measurement Information System (PROMIS) surveys for neuropathic pain
Time frame: 18 weeks
Physical Function
Assess differences in Patient Reported Outcomes (PROs) utilizing Patient Reported Outcomes Measurement Information System (PROMIS) surveys for physical function
Time frame: 18 weeks
Cancer Related Fatigue
Assess differences in Patient Reported Outcomes (PROs) utilizing Patient Reported Outcomes Measurement Information System (PROMIS) surveys for cancer related fatigue
Time frame: 18 weeks
Molecular biomarker: Insulin
Insulin concentration from human serum will be measured and reported as pg/ml using enzyme-linked immunosorbent assay (ELISA) performed by the Comprehensive Metabolic Core Facility at Northwestern University's Feinberg School of Medicine
Time frame: 18 weeks
Molecular biomarker: insulin-like growth factor-1
Insulin-like growth factor-1 concentration from human serum will be measured and reported as pg/ml using enzyme-linked immunosorbent assay (ELISA) performed by the Comprehensive Metabolic Core Facility at Northwestern University's Feinberg School of Medicine
Time frame: 18 weeks
Molecular biomarker: Insulin-like growth factor Binding Protein-1
Insulin-like growth factor Binding Protein-1 concentration from human serum will be measured and reported as pg/ml using enzyme-linked immunosorbent assay (ELISA) performed by the Comprehensive Metabolic Core Facility at Northwestern University's Feinberg School of Medicine
Time frame: 18 weeks
Molecular biomarker: Estrone
Estrone concentration from human serum will be measured and reported as pg/ml using enzyme-linked immunosorbent assay (ELISA) performed by the Comprehensive Metabolic Core Facility at Northwestern University's Feinberg School of Medicine
Time frame: 18 weeks
Molecular biomarker: Progesterone
Progesterone concentration from human serum will be measured and reported as pg/ml using enzyme-linked immunosorbent assay (ELISA) performed by the Comprehensive Metabolic Core Facility at Northwestern University's Feinberg School of Medicine
Time frame: 18 weeks
Molecular biomarker: Testosterone
Testosterone concentration from human serum will be measured and reported as pg/ml using enzyme-linked immunosorbent assay (ELISA) performed by the Comprehensive Metabolic Core Facility at Northwestern University's Feinberg School of Medicine
Time frame: 18 weeks
Patient Satisfaction Questionnaire
Each patient's satisfaction with the diet intervention during chemotherapy will be assessed using a 12-question survey distributed to the participants randomized to the FAST intervention group. Participants will be asked questions regarding their satisfaction, feasibility, and ease of following the diet regimen.
Time frame: 18 weeks
Plan to share: No
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