Time-Restricted Eating for Childhood Cancer Survivors

Recruiting at 3 trial locations

Overseen By Danielle Friedman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Insulin, GLP-1 agonists

Disqualifiers: Non-US resident, Non-English speaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether time-restricted eating (TRE), combined with motivational support, can aid adult survivors of childhood cancer in losing weight and reducing heart-related risks. Participants in the experimental group will practice TRE, eating only during an 8-hour window each day, and will receive regular coaching and reminders. The trial compares this method to the standard approach of reviewing educational materials and monthly weigh-ins. Ideal candidates are adult survivors of childhood cancer who have maintained a stable weight recently and were previously treated with radiation. Participants must also have a body mass index (BMI) of 25 or higher, indicating they are overweight. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could improve health outcomes for survivors.

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 on oral medication for insulin resistance, high blood pressure, or cholesterol issues, your medication dose must be stable for more than 3 months.

What prior data suggests that time-restricted eating is safe for adult survivors of childhood cancer?

Research has shown that time-restricted eating (TRE) is generally safe for most people. Studies have found adherence rates between 67% and 98%, indicating that most people find it manageable. While some research has examined TRE's effects on cancer markers, it primarily focuses on potential health benefits rather than safety issues.

Limited information exists about specific side effects related to TRE. However, participants should monitor their well-being and consult a healthcare provider if any concerns arise during the study. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating for childhood cancer survivors because it offers a unique approach to managing weight and metabolism without relying on medication. Unlike traditional treatments that might involve dietary changes or medications, this method encourages fasting for 16 hours a day, which can potentially improve metabolic health and reduce the risk of obesity-related complications. Additionally, the inclusion of motivational support through health coaching and daily reminders can help participants stay on track, making it a promising option for long-term lifestyle change.

What evidence suggests that time-restricted eating is effective for weight loss and lowering cardiometabolic risk in childhood cancer survivors?

Studies have shown that time-restricted eating (TRE) can aid in weight management and enhance overall health. Those who follow TRE often experience improved quality of life and a reduced risk of metabolic health problems. Some research suggests that TRE might lower cancer risk by enhancing the body's energy processing. Participants in previous studies generally found TRE easy to adhere to. In this trial, the intervention group will practice TRE, which may help reduce cancer risk and improve metabolic health. This approach could particularly benefit childhood cancer survivors aiming to lose weight and lower their risk of heart and metabolic issues. ^{1 2 5 6 7}

Who Is on the Research Team?

Danielle Friedman, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult survivors of childhood cancer who are interested in weight loss and reducing their risk of heart-related health issues. Participants should be willing to engage in time-restricted eating, follow motivational sessions, and complete regular check-ins with a health coach.

Inclusion Criteria

Enrolled in the Childhood Cancer Survivor Study

Stable weight over the past 6 months (+/- 10 pounds)

I am 18 years old or older.

Exclusion Criteria

Already fasting >12 hours per 24-hour day

I have been diagnosed with type 1 diabetes.

History of an eating disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in time-restricted eating and receive motivational sessions with a health coach

12 months

Monthly weight check-ins, regular calls with health coach

Follow-up

Participants are monitored for changes in glucose, insulin, and HbA1c levels

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Time-Restricted Eating

Trial Overview The study tests if combining motivational coaching calls with time-restricted eating can help participants lose weight and lower cardiometabolic risks better than just reviewing educational materials and monthly weigh-ins.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 5 Interventions

Participants will be instructed to participate in time-restricted eating, building to a 16-hour fast per day (not eating or drinking calorie-enriched beverages such as soda or nutritional shakes for a 16-hour window, such as 6pm -10am or 7pm-11am). These participants will also receive motivational phone/video calls with a trained health coach, daily text message reminders of when to start and stop their fasting, and monthly weight check-ins.

Group II: Control Group Active Control 3 Interventions

Participants will receive the standard of care electronic handouts through the Way to Health platform, and monthly weight check-ins.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12567023/

Time-Restricted Eating and Prebiotic Supplementation ... The 5-year survival rate among pediatric cancer survivors (PCSs) is over 84%. There are over 420,000 PCSs identified within the United States [2] and a ...

2. researchgate.net researchgate.net/publication/396752911_Time-Restricted_Eating_and_Prebiotic_Supplementation_Demonstrate_Feasibility_and_Acceptability_in_Young_Adult_Pediatric_Cancer_Survivors_A_Randomized_Controlled_Pilot_Trial

Time-Restricted Eating and Prebiotic Supplementation ... Background: The optimization of treatment for pediatric cancer has increased 5-year survivor rates to over 80%. Currently, there are almost ...

3. academic.oup.com academic.oup.com/nutritionreviews/article/83/7/e1660/7745808

Clinical Impact of Time-restricted Eating on Cancer A high rate (67–98%) of TRE adherence was observed, alongside improvements in quality of life. Four articles assessed cancer markers and found a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12229459/

Time-restricted eating and cancer: lessons learned ... Full achievement of the potential of time-restricted eating would lead to decreased metabolic dysfunction, with a reduction in cancer risk and increased ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04722341?term=NCT04722341

Time-Restricted Eating and Cancer: Clinical Outcomes ... The purpose of this study is to test whether the timing of meals can improve treatment adverse events, influence tumor biology and alter a person's mood and ...

6. mdanderson.org mdanderson.org/newsroom/study-shows-diet-and-exercise-improve-treatment-outcomes-for-obese-pediatric-cancer-patients.h00-159148401.html

Study shows diet and exercise improve treatment ... Diet and exercise may improve treatment outcomes in pediatric cancer patients, according to a study at The University of Texas MD Anderson ...

7. nature.com nature.com/articles/pr2017225

Diet and exercise interventions for pediatric cancer patients ... As described above, high-sugar and high-fat diets are being documented to have a negative impact on treatment outcomes, whereas enrichment for ...