University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
Location status: Recruiting
NCT Number: NCT06482515
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Baltimore, Maryland, 21201, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Participants must…):
Exclusion criteria
(participants must not…)
Participants will be asked to eat all their food in a self-selected 10-hour eating window every day.
Participants will meet with a nutritionist to discuss their dietary habits and how they compare to the American Cancer Society nutrition guidelines.
Time frame: baseline, 6 weeks, 12 weeks
Multidimensional Fatigue Symptom Inventory-Short Form; the total MFSI-SF score ranges from -24 to 96 with a higher score indicating higher levels of fatigue
Contact information is provided by the study sponsor or research team.
University of Maryland, Baltimore
Other
Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue Among Blood Cancer Survivors (2458GCCC)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05256888
Behavior, Diet Therapy
Baltimore, Maryland, United States
View Trial DetailsNCT04626843
Behavior, Behavior, Animal
Victoria, British Columbia, Canada
View Trial DetailsNCT02429063
Fatigue, Neoplasms
Memphis, Tennessee, United States
View Trial DetailsNCT02647398
Behavior, Fatigue
Majadahonda, Madrid, Spain
View Trial Details