Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06482515

Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue

Led by University of Maryland, Baltimore · Updated on 2025-07-03

96

Participants Needed

1

Research Sites

199 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cancer-related fatigue affects at least 30-90% of patients with cancer, depending on the type of cancer and their treatment(s) (e.g., chemotherapy, radiation). It is not relieved by sleep or rest, and it sometimes can persist for years after a person's cancer was treated. The fatigue can be so bad that people cannot return to work, hobbies, family roles, or other daily activities, thereby greatly reducing quality of life. The causes of this fatigue are unknown, and we currently do not have anything that can reliably prevent or cure the fatigue. However, there are recent data suggesting that circadian rhythm, or a person's internal body clock, may be disrupted by the cancer experience and contribute to fatigue. Food intake is an external cue that can entrain circadian rhythm. We recently showed that cancer survivors are willing and able to eat all their food within a 10-hour eating window-a practice called time-restricted eating. Herein, we are testing time-restricted eating against a control group (matched for time-, attention, and expectancy) to see if time-restricted eating can indeed alleviate cancer-related fatigue. All participants will be asked to use the myCircadianClock smartphone app to log their food intake and weekly body weight measurements. The participants assigned to the time-restricted eating group will be asked to eat all their food in a 10-hour window during the day. People can choose their start time based on their schedule and preferences, but we ask that the window is the same for the whole study (e.g., 7am-5pm,9:30am-7:30pm). Black coffee and unsweetened tea are allowed before the eating window, and water and medicines are allowed at all times. The participants in the control group will meet with a nutritionist to discuss the American Cancer Society nutrition guidelines in cancer survivorship; they will not be restricted to when they can eat. Participants in both groups will give us valuable information regarding how diet is related to the experience of fatigue. The purpose of this study is to test the effects of a 12-week TRE intervention vs. an unrestricted eating pattern on fatigue, the sustainability of the program at 24 weeks, and the effects of TRE on circadian rhythm and sugar metabolism.

CONDITIONS

Official Title

Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a diagnosis of a hematologic neoplasm (e.g., leukemia, lymphoma, multiple myeloma)
  • Be at least 2 months post-treatment with chemotherapy, radiation, targeted therapy, CAR-T cell therapy, stem cell transplant, or other therapy
  • Have a baseline level of fatigue defined by one or more of the following: worst fatigue score of 4 or higher on a 0-10 scale, habit of daytime naps, or fatigue interfering with work or social activities
  • Be able to speak and/or read and write in English or Spanish
  • Be at least 18 years old
  • Be able to provide informed consent
Not Eligible

You will not qualify if you...

  • Have a body mass index under 18.5 kg/m2 (underweight)
  • Already eat all food within a 10-hour window or shorter most days (6/7 days per week)
  • Regularly work night shifts away from home
  • Have surgery planned during the study period
  • Have any contraindications to the nutrition intervention, such as type 1 diabetes, risk of low blood sugar, pregnancy, breastfeeding, or recent eating disorder
  • Be taking insulin
  • Be on enteral or parenteral nutrition

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Maryland, Baltimore

Baltimore, Maryland, United States, 21201

Actively Recruiting

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Research Team

A

Amber Kleckner

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue | DecenTrialz