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NCT06482515 · ClinicalTrials.gov registry record · Phase 2
Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue
A Phase 2 study of Neoplasms and Fatigue, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT06482515 is a Phase 2 study of Neoplasms and Fatigue that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 96 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06482515, a Phase 2 study of Neoplasms and Fatigue, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study 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 expe
Conditions Studied
Interventions
- BEHAVIORAL Time-restricted eating
- BEHAVIORAL Nutrition counseling
Study Locations (1)
Maryland
- University of Maryland, Baltimore - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2024-11-04 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06482515
The ClinicalTrials.gov registry entry for NCT06482515 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (94% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Time-restricted eating is the first listed.
NCT06482515 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06482515 about?
NCT06482515 is a clinical study titled "Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue". 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 t...
What is the current status of trial NCT06482515?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2024-11-04. Estimated completion is 2028-08-31.
What conditions does trial NCT06482515 study?
This clinical trial studies the following conditions: Neoplasms, Fatigue, Survivorship, Diet Habit, Blood Cancer.
What interventions are being tested in trial NCT06482515?
The interventions under investigation include: Time-restricted eating (BEHAVIORAL), Nutrition counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT06482515?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06482515 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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