NeoplasmsNCT05256888

Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

A study testing Time-restricted eating and Healthy lifestyle education in people with Neoplasms and Therapy, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms, Therapy, Fatigue
What is being tested?: Time-restricted eating and Healthy lifestyle education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 26 Jan 2023to 1 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have completed adjuvant chemotherapy, surgery, and/or radiation for cancer, including chemotherapy for hematologic neoplasms, at least 2 months and not more than 2 years prior to enrolling,
Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
Be able to speak and/or read and write in English,
Be at least 18 years old,
Own a smartphone,
Be willing and able to adhere to study procedures, including use of a smartphone app, and
Be able to provide informed consent.

Who cannot join

Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week,
Be underweight, as defined as a body mass index ≤18.5 kg/m2,
Have surgery planned during the study duration,
Have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder),
Be taking insulin, or
Be on enteral or parenteral nutrition.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Maryland, Baltimore
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Time-Restricted Eating to Address Persistent Cancer-Related Fatigue: The Fatigue REDuction After Cancer (FREDA) Trial

This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 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.

Conditions: Neoplasms, Therapy, Fatigue, Diet Therapy, Time, Survivorship
Being tested: Time-restricted eating, Healthy lifestyle education
Medical subject headings: Neoplasms, Fatigue, Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Time-restricted eatingBehavioural
12 weeks of time-restricted eating (10-hour window)
Healthy lifestyle educationBehavioural
Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks

Study groups in NCT05256888
Study group	Role	What they receive
Time-restricted eating	Experimental	Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship. Receives: Behavioral: Time-restricted eating; Behavioral: Healthy lifestyle education
Control	Other	Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship. Receives: Behavioral: Healthy lifestyle education

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study
To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.
Measured: 12 weeks
Fatigue, as Assessed Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire
FACIT-F fatigue subscale scores will be compared for those in the time-restricted eating group vs. the control group at week 12, controlling for baseline levels. This questionnaire is 13-items long. The scale is from 0-52, and a higher score indicates less fatigue.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jan 20231 Jun 2024

First posted25 Feb 2022
Study start26 Jan 2023
Primary completion1 Jun 2024
Study completion1 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05256888
Sponsor's protocol ID: HP-00099067
Other IDs: UL1TR003098
Status last verified: Jul 2026
First submitted: 16 Feb 2022
Last updated: 20 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Kleckner AS, Clingan CL, Youngblood SM, Kleckner IR, Quick L, Elrod RD, Zhu S, Manoogian ENC, Panda S, Badros AZ, Emadi A. Time-restricted eating to address persistent cancer-related fatigue among cancer survivors: a randomized controlled trial. Support Care Cancer. 2025 Apr 5;33(4):353. doi: 10.1007/s00520-025-09394-w.
PubMed 40186671

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Time-Restricted Eating to Address Persistent Cancer-Related Fatigue: The Fatigue REDuction After Cancer (FREDA) Trial
ClinicalTrials.gov ID: NCT05256888
Acronym / sponsor ID: HP-00099067
Conditions: Neoplasms, Therapy, Fatigue, Diet Therapy, Time, Survivorship
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 26 Jan 2023 (actual)
Primary completion: 1 Jun 2024 (actual)
Study completion: 1 Jun 2024 (actual)
First posted: 25 Feb 2022 (actual)
Results: Posted 7 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Time-restricted eating	Experimental	Behavioral: Time-restricted eating, Behavioral: Healthy lifestyle educationParticipants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship.
Control	Other	Behavioral: Healthy lifestyle educationParticipants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Have completed adjuvant chemotherapy, surgery, and/or radiation for cancer, including chemotherapy for hematologic neoplasms, at least 2 months and not more than 2 years prior to enrolling,
Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
Be able to speak and/or read and write in English,
Be at least 18 years old,
Own a smartphone,

Key exclusion criteria (6 listed)

Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week,
Be underweight, as defined as a body mass index ≤18.5 kg/m2,
Have surgery planned during the study duration,
Have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder),
Be taking insulin, or

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Time-restricted eating12 weeks of time-restricted eating (10-hour window)	Behavioural	Time-restricted eating
Healthy lifestyle educationWeekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks	Behavioural	Control, Time-restricted eating

Primary outcome

Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study
Time frame: 12 weeks
To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.
Fatigue, as Assessed Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire
Time frame: 12 weeks
FACIT-F fatigue subscale scores will be compared for those in the time-restricted eating group vs. the control group at week 12, controlling for baseline levels. This questionnaire is 13-items long. The scale is from 0-52, and a higher score indicates less fatigue.

Results and safety

Results posted to the registry on 7 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Time-restricted Eating	15	14
Control	15	11

Primary outcome: Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	All Participants n = 50
Value	25

Primary outcome: Fatigue, as Assessed Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire

Time frame: 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Time-restricted Eating n = 11	Control n = 14
Value	38.7 (9.2)	37.2 (9.1)

Time-restricted Eating vs Control: Slope: -1.77, p = 0.11, Regression, Linear

Adverse events

Time frame: 13 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Time-restricted Eating	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
Control	2 of 15 (13.3%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40186671Kleckner AS, Clingan CL, Youngblood SM, Kleckner IR, Quick L, Elrod RD, Zhu S, Manoogian ENC, Panda S, Badros AZ, Emadi A. Time-restricted eating to address persistent cancer-related fatigue among cancer survivors: a randomized controlled trial. Support Care Cancer. 2025 Apr 5;33(4):353. doi: 10.1007/s00520-025-09394-w.

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Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Time-restricted eating and Healthy lifestyle education in people with Neoplasms and Therapy, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05256888, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.