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

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

NCT ID: NCT06482515

Condition: Neoplasms
Blood Cancer
Fatigue
Diet Habit
Survivorship
Fasting, Intermittent

Conditions: Official terms:
Hematologic Neoplasms
Fatigue

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Time-restricted eating
Description: Participants will be asked to eat all their food in a self-selected 10-hour eating window every day.
Arm group label: Time-restricted eating

Intervention type: Behavioral
Intervention name: Nutrition counseling
Description: Participants will meet with a nutritionist to discuss their dietary habits and how they compare to the American Cancer Society nutrition guidelines.
Arm group label: Time-restricted eating
Arm group label: Time-unrestricted eating

Summary: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Maryland, Baltimore

Address:
City: Baltimore
Zip: 21201
Country: United States

Status: Recruiting

Contact:
Last name: Amber Kleckner, PhD

Phone: 410-706-5961
Email: amber.kleckner@umaryland.edu

Start date: November 4, 2024

Completion date: October 2030

Lead sponsor:
Agency: University of Maryland, Baltimore
Agency class: Other

Source: University of Maryland, Baltimore

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06482515