Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05256888
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2022-02-16
Brief Title:
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue The Fatigue REDuction After Cancer FREDA Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the interventions preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control Participants will be randomized 11 to one of two arms time-restricted eating or control Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages water is allowed any time black coffee and unsweetened tea are allowed in the morning Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship This study will also explore relationships between fatigue circadian rhythm and glucose metabolism
The hypothesis is that recruitment will be feasible and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control accounting for baseline fatigue levels
The hypothesis is that recruitment will be feasible and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control accounting for baseline fatigue levels
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1TR003098 | NIH | None | httpsreporternihgovquickSearchUL1TR003098 |