42 Participants NeededMy employer runs this trial

Fasting for Endometrial Cancer

(FIT-ENDO Trial)

GE
Overseen ByGrey E Freylersythe, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety of overnight fasting for women with endometrial cancer preparing for surgery. Researchers aim to determine if fasting overnight can address metabolism issues, such as high blood sugar, which might influence cancer growth or treatment success. Participants will either follow a prolonged overnight fasting (POF) plan or receive general health coaching to compare outcomes. Women diagnosed with low-grade endometrial cancer and planning surgery may be suitable candidates for this study. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance pre-surgical care for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking insulin, metformin, sulfonylureas, or GLP-1 agonist medications for diabetes, you cannot participate in the trial.

What prior data suggests that prolonged overnight fasting is safe for women with endometrial cancer?

Studies have shown that fasting overnight for an extended period is generally well-tolerated. Research from a similar fasting study found that 95% of participants successfully fasted for at least 70% of the study nights, suggesting that many can manage the fasting routine without major issues.

Additionally, fasting has been linked to potential health benefits, such as reducing inflammation and improving metabolism. These findings are promising for its safety and effectiveness. However, as this is an experimental treatment, participants should monitor any personal health concerns during the trial and discuss any worries with the study team.12345

Why are researchers excited about this trial?

Researchers are excited about the potential of prolonged overnight fasting (POF) for endometrial cancer because it offers a novel approach to treatment without the use of drugs or invasive procedures. Unlike traditional treatments like surgery, radiation, or chemotherapy, which target the cancer cells directly, POF aims to improve overall metabolic health by altering eating patterns. This method could potentially reduce cancer-related fatigue and improve recovery without the side effects associated with more aggressive treatments. Additionally, the integration of a nutrition health coach and the use of wearable technology for monitoring make this approach personalized and user-friendly, which might enhance patient engagement and outcomes.

What evidence suggests that prolonged overnight fasting might be an effective treatment for endometrial cancer?

This trial will evaluate the effects of Prolonged Overnight Fasting (POF) on women with endometrial cancer. Studies have shown that fasting overnight for an extended period might benefit these patients. Early research indicates that fasting can help address metabolic issues, such as high blood sugar, which is common in these patients. This is important because high blood sugar can lead to inflammation, potentially aiding cancer growth or reducing treatment effectiveness. Similar studies have linked fasting to improvements in anxiety, body weight, depression, and fatigue. Animal studies suggest that fasting could slow tumor growth and enhance treatment efficacy. Participants in this trial will join either the POF group or an attention control group to assess these potential benefits.12367

Who Is on the Research Team?

TE

Tracy E Crane, PhD, RDN

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for women diagnosed with endometrial cancer who are scheduled to have surgery (hysterectomy).

Inclusion Criteria

Internet access on a smart phone, tablet, or computer
Approval to participate from treating oncologist, confirmed via email or in writing
Able to provide consent
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Exclusion Criteria

Unable to read/understand English or Spanish
Engaging in structured fasting consistently (≥50% of the time) for more than 12 hours/night
Presence of a severe medical or psychiatric condition or medication that would preclude participation of the study intervention, including unstable cardiac disease
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Pre-Surgery Intervention

Participants begin prolonged overnight fasting (POF) or receive general health coaching for 3 weeks prior to surgery. Activities include weekly meetings with a nutrition health coach, blood specimen collections, wearing a blood sugar monitor and physical activity tracker, and completing various questionnaires.

3 weeks
Weekly video or phone calls

Post-Surgery Intervention

Participants continue with the prolonged overnight fasting (POF) or general health coaching for 6 weeks post-surgery. Activities include continued weekly meetings, blood specimen collections, and monitoring.

6 weeks
Weekly video or phone calls

Follow-up

Participants are monitored for safety and effectiveness after the intervention. This includes final assessments and data collection.

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Prolonged Overnight Fasting (POF)

Trial Overview

The study is testing if it’s safe for these women to fast overnight before their surgery. Researchers will collect blood samples and monitor blood sugar levels during the process.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Prolonged Overnight Fasting (POF) GroupExperimental Treatment4 Interventions
Group II: Attention Control GroupExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Florida Department of Health

Collaborator

Trials
30
Recruited
13,000+

Citations

Sylvester Comprehensive Cancer Center Launches Clinical ...

The FIT-ENDO trial is testing prolonged overnight fasting, which aligns food intake with the body's natural circadian rhythms.

NCT07622901 | Fasting InTervention for Endometrial Cancer

The goal of this study is to find out if it is safe for women with endometrial cancer who are going to have surgery to fast (not eat) ...

Fasting Intervention for Ovarian Cancer (FAST Trial)

Participants experienced significant improvements in anxiety, BMI, depression, and fatigue after 12 weeks of fasting, suggesting that POF may be a beneficial ...

Ongoing Research Dynamic Page (List)

The FIT-ENDO study is a clinical trial investigating how prolonged overnight fasting might benefit women with endometrial cancer. This randomized controlled ...

Intermittent Fasting Shows Potential Antitumor Role in ...

Intermittent fasting or intermittent energy restriction (IER) has been tolerated better than other dietary interventions and has shown antitumorigenic effects ...

Prolonged Nightly Fasting and Breast Cancer Prognosis - PMC

Taken together, the rodent and human data support the hypothesis that a prolonged nightly fasting interval could reduce cancer risk and improve cancer outcomes.

Fasting InTervention for Endometrial Cancer

The goal of this study is to find out if it is safe for women with endometrial cancer who are going to have surgery to fast (not eat) overnight.