Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482515
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-25
Brief Title:
Take the Reins The Effects of Nutrient Timing on Cancer-related Fatigue
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Take the Reins The Effects of Nutrient Timing on Cancer-related Fatigue Among Blood Cancer Survivors 2458GCCC
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cancer-related fatigue affects at least 30-90 of patients with cancer depending on the type of cancer and their treatments eg chemotherapy radiation It is not relieved by sleep or rest and it sometimes can persist for years after a persons 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 persons 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 eg 7am-5pm930am-730pm 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None