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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06482515
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Blood Cancer
  • Diet Habit
  • Fasting, Intermittent
  • Fatigue
  • Neoplasms
  • Survivorship

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 4, 2024
Status verified
Jun 2026
Primary completion
May 1, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Time-restricted eating
  • Active Comparator: Time-unrestricted eating

Primary Outcome Measure

Fatigue [ Time Frame: baseline, 6 weeks, 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland, BaltimoreBaltimoreMaryland21201
Amber Kleckner, PhD
[email protected]
4107065961

Find similar trials in Baltimore, MD

By research site
University of Maryland, Baltimore· Baltimore, MD

Related Studies