NeoplasmsPhase 2NCT06482515
Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue
A Phase 2 study testing Time-restricted eating and Nutrition counseling in people with Neoplasms and Blood Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Blood Cancer, Fatigue
- What is being tested?
- Time-restricted eating and Nutrition counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2024to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 a diagnosis of a hematologic neoplasm (e.g., leukemia, lymphoma, multiple myeloma);
- Be at least 2 months post-treatment with chemotherapy, radiation, targeted therapy, chimeric antigen receptor (CAR)-T cell therapy, stem cell transplant, or another therapy (maintenance therapies are okay; steady unchanged treatment for relapsed disease for >2 months and expected to stay on it until progression is okay);
- Have a baseline level of fatigue, as determined by at least one of the following:
- Reporting a score of 4 or higher in response to the question, "What was your worst fatigue in the last week, on a scale of 0-10, where 0 is no fatigue and 10 is the worst fatigue?"
- In the habit of taking daytime naps,
- Have fatigue that interferes with their ability to work, engage in social events, or is more than would be expected from physical exertion,
Show all 9Show fewer
- Be able to speak and/or read and write in English or Spanish;
- Be at least 18 years old; and
- Be able to provide informed consent.
Who cannot join
- Be underweight, as defined as a body mass index <18.5 kg/m2;
- Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week;
- Be employed in a job where they regularly work away from the home at night (e.g., night shift);
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Amber Kleckner, PhD, 4107065961, amber.kleckner@umaryland.edu
About this study
Official title: Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue Among Blood Cancer Survivors (2458GCCC)
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.
- Conditions
- Neoplasms, Blood Cancer, Fatigue, Diet Habit, Survivorship, Fasting, Intermittent
- Being tested
- Time-restricted eating, Nutrition counseling
- Medical subject headings
- Neoplasms, Hematologic Neoplasms, Fatigue, Feeding Behavior, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
Participants will be asked to eat all their food in a self-selected 10-hour eating window every day.
Nutrition counselingBehavioural
Participants will meet with a nutritionist to discuss their dietary habits and how they compare to the American Cancer Society nutrition guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating | Experimental | Not described Receives: Behavioral: Time-restricted eating; Behavioral: Nutrition counseling |
| Time-unrestricted eating | Active comparator | Not described Receives: Behavioral: Nutrition counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Multidimensional Fatigue Symptom Inventory-Short Form; the total MFSI-SF score ranges from -24 to 96 with a higher score indicating higher levels of fatigue
Measured: baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start4 Nov 2024
- Primary completion1 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Kleckner, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482515
- Sponsor's protocol ID
- HP-00110284
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data files and transcripts will be shared using Dryad (datadryad.org) per guidelines of the data repository, or similar repositories. All de-identified demographic data, clinical record data, and arm allocation from the parent trial will be shared in conjunction with the data to increase the usefulness to other researchers. In addition, the interview guide will be shared in text format (.pdf or .txt). The blank questionnaires will also be shared via the same repository.
Publications
Kleckner AS, Clingan CL, Badros AZ, Manoogian ENC, Mustian KM, Panda S, Ryan AS, Zhu S. Take the reins: a study protocol of a randomized controlled trial testing the effects of time-restricted eating vs. nutrition control on cancer-related fatigue among survivors of hematological malignancies. BMC Nutr. 2025 Oct 31;11(1):200. doi: 10.1186/s40795-025-01185-0.
PubMed 41174725
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue Among Blood Cancer Survivors (2458GCCC)
- ClinicalTrials.gov ID
- NCT06482515
- Acronym / sponsor ID
- HP-00110284
- Conditions
- Neoplasms, Blood Cancer, Fatigue, Diet Habit, Survivorship, Fasting, Intermittent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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: Nutrition counseling |
| Time-unrestricted eating | Active comparator | Behavioral: Nutrition counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have a diagnosis of a hematologic neoplasm (e.g., leukemia, lymphoma, multiple myeloma);
- Be at least 2 months post-treatment with chemotherapy, radiation, targeted therapy, chimeric antigen receptor (CAR)-T cell therapy, stem cell transplant, or another therapy (maintenance therapies are okay; steady unchanged treatment for relapsed disease for >2 months and expected to stay on it until progression is okay);
- Have a baseline level of fatigue, as determined by at least one of the following:
- Be able to speak and/or read and write in English or Spanish;
- Be at least 18 years old; and
Key exclusion criteria (7 listed)
- Be underweight, as defined as a body mass index <18.5 kg/m2;
- Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week;
- Be employed in a job where they regularly work away from the home at night (e.g., night shift);
- 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);
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 eatingParticipants will be asked to eat all their food in a self-selected 10-hour eating window every day. | Behavioural | Time-restricted eating |
| Nutrition counselingParticipants will meet with a nutritionist to discuss their dietary habits and how they compare to the American Cancer Society nutrition guidelines. | Behavioural | Time-restricted eating, Time-unrestricted eating |
Primary outcome
Fatigue
Time frame: baseline, 6 weeks, 12 weeks
Multidimensional Fatigue Symptom Inventory-Short Form; the total MFSI-SF score ranges from -24 to 96 with a higher score indicating higher levels of fatigue
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 41174725Kleckner AS, Clingan CL, Badros AZ, Manoogian ENC, Mustian KM, Panda S, Ryan AS, Zhu S. Take the reins: a study protocol of a randomized controlled trial testing the effects of time-restricted eating vs. nutrition control on cancer-related fatigue among survivors of hematological malignancies. BMC Nutr. 2025 Oct 31;11(1):200. doi: 10.1186/s40795-025-01185-0.
- Individual participant dataSharing planned: Yes. Data files and transcripts will be shared using Dryad (datadryad.org) per guidelines of the data repository, or similar repositories. All de-identified demographic data, clinical record data, and arm allocation from the parent trial will be shared in conjunction with the data to increase the usefulness to other researchers. In addition, the interview guide will be shared in text format (.pdf or .txt). The blank questionnaires will also be shared via the same repository.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Time-restricted eating and Nutrition counseling in people with Neoplasms and Blood Cancer, 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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Jun 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amber Kleckner (4107065961, amber.kleckner@umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: baseline, 6 weeks, 12 weeks). 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 NCT06482515, 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 5 Jun 2026.