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

Is NCT06482515 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for neoplasms.

Phase 2RecruitingUniversity of Maryland, BaltimoreNCT06482515Data as of May 2026

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.

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Extracted eligibility criteria

Prior therapy

Min 1 prior line

Must have received: chemotherapy

Be at least 2 months post-treatment with chemotherapy

Must have received: radiation therapy

Be at least 2 months post-treatment with radiation

Must have received: targeted therapy

Be at least 2 months post-treatment with targeted therapy

Must have received: CAR-T cell therapy

Be at least 2 months post-treatment with chimeric antigen receptor (CAR)-T cell therapy

Must have received: stem cell transplant

Be at least 2 months post-treatment with stem cell transplant

Must have received: other therapy

Be at least 2 months post-treatment with another therapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Maryland, Baltimore · Baltimore, Maryland

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