132 Participants NeededMy employer runs this trial

Time-Restricted Eating for Fatigue in Cancer Patients

(THYME Trial)

AK
Overseen ByAmber Kleckner, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Maryland, Baltimore
Must be taking: Hormone therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating can reduce fatigue and slow frailty onset in individuals with chronic cancer. Participants will either follow a time-restricted eating plan, eating within a 10-hour window during the day, or receive nutrition counseling without specific eating times. It targets individuals aged 55 or older with prostate cancer or metastatic breast cancer who typically eat over more than 12 hours a day. The goal is to determine if aligning eating patterns with daylight hours can improve energy levels and overall health. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that time-restricted eating (TRE) is safe for people with cancer. Studies have found that a 10-hour TRE plan is both feasible and safe for cancer survivors. In one study, participants who followed this eating pattern reported feeling less tired after just two weeks. Other research suggests that fasting-based methods like TRE can help reduce fatigue and some digestive issues in cancer patients. These findings indicate that TRE might be a well-tolerated option for managing cancer-related fatigue.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about time-restricted eating for fatigue in cancer patients because it offers a novel approach distinct from current treatments like medication or lifestyle changes aimed at energy management. Unlike traditional methods that often focus on supplements or medication to combat fatigue, this approach emphasizes the timing of food intake, which could naturally enhance energy levels and improve overall well-being. By potentially syncing with the body's natural circadian rhythms, time-restricted eating might help regulate energy more efficiently, providing a non-invasive and drug-free method to manage fatigue.

What evidence suggests that this trial's treatments could be effective for fatigue in cancer patients?

Research has shown that time-restricted eating (TRE), studied in this trial, can help reduce tiredness in cancer patients. Participants will join either a time-restricted eating group or a time-unrestricted eating group. Studies have found that eating within a 10-hour window noticeably improved fatigue levels after just two weeks. TRE is considered safe and feasible for people with cancer and may help ease ongoing tiredness related to cancer. Intermittent fasting, which includes TRE, might also lessen side effects from cancer treatments. These findings suggest that TRE could effectively manage fatigue in cancer patients.12346

Are You a Good Fit for This Trial?

This trial is for adults aged 55 or older with prostate cancer or metastatic breast cancer who eat over more than 12 hours a day and do not work night shifts. Participants should be experiencing fatigue or frailty related to their cancer.

Inclusion Criteria

Have a life expectancy of ≥1 year
I am 55 years old or older.
Have a body mass index (BMI) ≥18.5 kg/m^2
See 4 more

Exclusion Criteria

Be employed in overnight shift work more than 1 day/week on average
I do not have any medical reasons that prevent me from having this treatment.
Have had time zone travel ≥2 time zones away within the last 4 weeks
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week intervention comparing time-restricted eating with a nutrition counseling control

12 weeks

Follow-up

Participants are monitored for fatigue and frailty at 6- and 12-month follow-up time points

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Nutrition counseling
  • Time-restricted eating

Trial Overview

The study compares two groups: one follows time-restricted eating (eating only during a set 10-hour window each day), while the other receives standard nutrition counseling without any time limits. The goal is to see which approach better reduces fatigue and frailty over 12 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Time-restricted eatingExperimental Treatment2 Interventions
Group II: Time-unrestricted eatingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36131848/

Time-restricted Eating to Address Cancer-related Fatigue ...

A 10-h TRE intervention was feasible and safe among survivors, and fatigue improved with a moderate effect size after two weeks.

Intermittent fasting and its impact on toxicities, symptoms ...

intermittent fasting interventions may improve fatigue and reduce gastrointestinal toxicities in certain patients with cancer.

Time-restricted Eating to Address Cancer-related Fatigue ...

A 10-h TRE intervention was feasible and safe among survivors, and fatigue improved with a moderate effect size after two weeks.

Fasting-Based Dietary Interventions in Cancer Patients and ...

Conclusions: Fasting-based interventions have the potential to be feasible and well tolerated among cancer patients and survivors, with early ...

Clinical Impact of Time-restricted Eating on Cancer

Specifically, women who fasted for less than 13 hours per night were at increased risk of breast cancer recurrence compared with women who ...

Time-Restricted Eating for Cancer-related Fatigue

In a study involving adults with obesity, both 4-hour and 6-hour time-restricted feeding (TRF) regimens led to comparable weight loss of about 3% over 8 weeks, ...