Fatigue in Cancer SurvivorsPhase 2THYMENCT07826871
Targeting HealthY Eating to Maintain Energy While Living With Cancer
A Phase 2 study testing Nutrition counseling and Time-restricted eating in people with Fatigue in Cancer Survivors, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Treatments for advanced and metastatic cancer can cause fatigue and accelerate the progression to frailty. There are few effective mitigation strategies for fatigue or frailty in chronic cancer in part because the underlying etiology and pathophysiology are not well understood. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Fatigue in Cancer Survivors
- What is being tested?
- Nutrition counseling and Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Sep 2033
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of prostate cancer or metastatic breast cancer
- Have current use or a history of hormone therapy (e.g., androgen deprivation therapy, aromatase inhibitors)
- Have a life expectancy of ≥1 year
- Be 55 years of age or older
- Typically consume food within a window that is greater than 12 hours
- Be able to communicate in English
- Have a body mass index (BMI) ≥18.5 kg/m^2
Who cannot join
- Be employed in overnight shift work more than 1 day/week on average
- Be on enteral or parenteral nutrition
- Have any contraindications to the proposed intervention as identified by their medical provider (e.g., type 1 diabetes, pregnancy, recent history of an eating disorder, recent bariatric surgery, insulin dependency)
- Have had time zone travel ≥2 time zones away within the last 4 weeks, or have time zone travel (≥2 time zones away) planned for more than 2 days in the next 14 weeks.
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, 410-706-5961, amber.kleckner@umaryland.edu
About this study
Official title: Targeting Healthy Eating to Maintain Energy While Living With Cancer (THYME) (2668GCCC)
Treatments for advanced and metastatic cancer can cause fatigue and accelerate the progression to frailty. There are few effective mitigation strategies for fatigue or frailty in chronic cancer in part because the underlying etiology and pathophysiology are not well understood. However, disruption of circadian rhythms is a mechanism that possibly underlies fatigue and other components of frailty. Time-restricted eating is a daily eating pattern that entails consuming food within a defined, consistent window (e.g., 10 hours) every day. When the eating window aligns with the daylight hours, it entrains circadian processes and modulates physiological regulation of whole-body metabolism. Stronger physiological regulation means that the body will better be able to respond to physiological perturbations such as standing up from lying down, walking vs. sitting still, and eating food, as well as sleep more efficiently and have more perceived energy during the day. It is also predicted that patients will be less vulnerable to the aging process. It is hypothesized that time-restricted eating can alleviate fatigue and slow the progression to frailty in older adults with cancer as a chronic condition via regulating circadian rhythms and improving physiological responsiveness. This project is a 12-week, two-arm, phase II randomized controlled trial comparing the effects of time-restricted eating (10 h daytime feeding/14 h fasting at night) vs. a nutrition counseling control intervention (no time component) on fatigue; 6- and 12-month follow-up time points are also planned. A total of 132 patients with prostate cancer or metastatic breast cancer will be recruited; eligible participants will be 55 years or older, consume food within a window that is >12 h at baseline, and not be employed in night-shift work. They will be randomized 1:1, intervention: control. At baseline, 12 weeks (post-intervention), and 12 months, we will assess patient-reported fatigue (Aim 1); frailty via Fried's frailty criteria (Aim 2); and measures of circadian rhythms (i.e., rest-activity rhythm, urinary hormones) and physiological responsiveness (i.e., lying vs. standing blood pressure, sitting vs. walking heart rate, glucose tolerance, phosphocreatine recovery) (Aim 3, mechanistic aim). The time-restricted eating intervention is scalable and inexpensive, lending itself to accessibility for the vast majority of people living with cancer as a chronic condition. Data generated herein will be used to inform a larger, phase III multisite clinical trial testing the effects of time-restricted eating on fatigue and frailty among older adults living with cancer and further optimize interventions that entrain circadian rhythms and improve energy production.
- Conditions
- Fatigue in Cancer Survivors
- Being tested
- Nutrition counseling, Time-restricted eating
- Keywords
- intermittent fasting, survivorship, frailty, nutrition
- Medical subject headings
- Intermittent Fasting, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition counselingBehavioural
Participants will meet with a nutritionist to discuss their dietary habits and how they compare to the American Cancer Society nutrition guidelines.
Time-restricted eatingBehavioural
Participants will be asked to eat all their food in a self-selected 10-hour eating window every day.
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating | Experimental | Not described Receives: Behavioral: Nutrition counseling; Behavioral: Time-restricted eating |
| 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, measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
The Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) is a 30-item self-report questionnaire that assesses five dimensions of fatigue: General, Physical, Emotional, Mental, and Vigor. Responses are rated on a 5-point scale based on symptoms experienced during the previous week. The total fatigue score is calculated by summing the General, Physical, Emotional, and Mental Fatigue subscale scores and subtracting the Vigor subscale score. Total scores range from -24 to 96, with higher scores indicating greater 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.
- First posted17 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue in Cancer SurvivorsStudies 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826871
- Sponsor's protocol ID
- HP-00119566
- Acronym
- THYME
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Healthy Eating to Maintain Energy While Living With Cancer (THYME) (2668GCCC)
- ClinicalTrials.gov ID
- NCT07826871
- Acronym / sponsor ID
- THYME / HP-00119566
- Conditions
- Fatigue in Cancer Survivors
- Keywords
- intermittent fasting, survivorship, frailty, nutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 17 Sep 2026 (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.
Treatments for advanced and metastatic cancer can cause fatigue and accelerate the progression to frailty. There are few effective mitigation strategies for fatigue or frailty in chronic cancer in part because the underlying etiology and pathophysiology are not well understood. However, disruption of circadian rhythms is a mechanism that possibly underlies fatigue and other components of frailty. Time-restricted eating is a daily eating pattern that entails consuming food within a defined, consistent window (e.g., 10 hours) every day. When the eating window aligns with the daylight hours, it entrains circadian processes and modulates physiological regulation of whole-body metabolism. Stronger physiological regulation means that the body will better be able to respond to physiological perturbations such as standing up from lying down, walking vs. sitting still, and eating food, as well as sleep more efficiently and have more perceived energy during the day. It is also predicted that patients will be less vulnerable to the aging process. It is hypothesized that time-restricted eating can alleviate fatigue and slow the progression to frailty in older adults with cancer as a chronic condition via regulating circadian rhythms and improving physiological responsiveness. This project is a 12-week, two-arm, phase II randomized controlled trial comparing the effects of time-restricted eating (10 h daytime feeding/14 h fasting at night) vs. a nutrition counseling control intervention (no time component) on fatigue; 6- and 12-month follow-up time points are also planned. A total of 132 patients with prostate cancer or metastatic breast cancer will be recruited; eligible participants will be 55 years or older, consume food within a window that is >12 h at baseline, and not be employed in night-shift work. They will be randomized 1:1, intervention: control. At baseline, 12 weeks (post-intervention), and 12 months, we will assess patient-reported fatigue (Aim 1); frailty via Fried's frailty criteria (Aim 2); and measures of circadian rhythms (i.e., rest-activity rhythm, urinary hormones) and physiological responsiveness (i.e., lying vs. standing blood pressure, sitting vs. walking heart rate, glucose tolerance, phosphocreatine recovery) (Aim 3, mechanistic aim). The time-restricted eating intervention is scalable and inexpensive, lending itself to accessibility for the vast majority of people living with cancer as a chronic condition. Data generated herein will be used to inform a larger, phase III multisite clinical trial testing the effects of time-restricted eating on fatigue and frailty among older adults living with cancer and further optimize interventions that entrain circadian rhythms and improve energy production.
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: Nutrition counseling, Behavioral: Time-restricted eating |
| Time-unrestricted eating | Active comparator | Behavioral: Nutrition counseling |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a diagnosis of prostate cancer or metastatic breast cancer
- Have current use or a history of hormone therapy (e.g., androgen deprivation therapy, aromatase inhibitors)
- Have a life expectancy of ≥1 year
- Be 55 years of age or older
- Typically consume food within a window that is greater than 12 hours
Key exclusion criteria (4 listed)
- Be employed in overnight shift work more than 1 day/week on average
- Be on enteral or parenteral nutrition
- Have any contraindications to the proposed intervention as identified by their medical provider (e.g., type 1 diabetes, pregnancy, recent history of an eating disorder, recent bariatric surgery, insulin dependency)
- Have had time zone travel ≥2 time zones away within the last 4 weeks, or have time zone travel (≥2 time zones away) planned for more than 2 days in the next 14 weeks.
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 |
|---|---|---|
| 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 |
| 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 |
Primary outcome
Fatigue, measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
Time frame: 12 weeks
The Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) is a 30-item self-report questionnaire that assesses five dimensions of fatigue: General, Physical, Emotional, Mental, and Vigor. Responses are rated on a 5-point scale based on symptoms experienced during the previous week. The total fatigue score is calculated by summing the General, Physical, Emotional, and Mental Fatigue subscale scores and subtracting the Vigor subscale score. Total scores range from -24 to 96, with higher scores indicating greater 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 3 Nov 2026.
- Individual participant dataSharing planned: Yes
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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 Nutrition counseling and Time-restricted eating in people with Fatigue in Cancer Survivors, 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 4 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 3 Nov 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, PhD (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, measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.