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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

(Participants must...) - Have a diagnosis of a hematologic neoplasm (e.g., leukemia, lymphoma, multiple myeloma); - Be 2 months to 2 years post-treatment (e.g., chemotherapy, radiation, targeted therapy, CART cell therapy; maintenance therapies are okay); - Have a baseline level of fatigue, as determined by reporting a score of 4 or higher on the Brief Fatigue Inventory; - Be able to speak and/or read and write in English; - Be at least 18 years old; and - Be able to provide informed consent.

Exclusion Criteria

(Participants must not...) - Be underweight, as defined as a body mass index <18.5 kg/m2; - Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week; - Be employed in a job where they regularly work away from the home at night (e.g., night shift); - Have surgery planned during the study duration; - Have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder); - Be taking insulin; or - Be on enteral or parenteral nutrition

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Time-restricted eating
  • Behavioral: Time-restricted eating
    Participants will be asked to eat all their food in a self-selected 10-hour eating window every day.
  • Behavioral: Nutrition counseling
    Participants will meet with a nutritionist to discuss their dietary habits and how they compare to the American Cancer Society nutrition guidelines.
Active Comparator
Time-unrestricted eating
  • Behavioral: Nutrition counseling
    Participants will meet with a nutritionist to discuss their dietary habits and how they compare to the American Cancer Society nutrition guidelines.

Recruiting Locations

University of Maryland, Baltimore
Baltimore, Maryland 21201
Contact:
Amber Kleckner, PhD
410-706-5961
amber.kleckner@umaryland.edu

More Details

Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Amber Kleckner
4107065961
amber.kleckner@umaryland.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.