CancerNCT07524218
Effect of Meal Timing During Adjuvant Treatment for Cancer
A study testing Time-restricted eating, Questionnaire Administration and Biospecimen Collection in people with Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response, patient well-being and long-term metabolic health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Time-restricted eating, Questionnaire Administration and Biospecimen Collection
- Type of treatment
- Surgery or procedure, 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
- 12 Aug 2026to 31 Aug 2029
- Phase
- Interventional
- 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
- Age ≥18 years (no upper age limit)
- Any sex or gender
- Histologically or cytologically confirmed solid tumor treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation per standard of care)
- BMI ≥18.5 kg/m2
- Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions
Who cannot join
- No plan for systemic adjuvant therapy after surgery
- Strictly adhering to a <10-hour eating window on most days
- Regular overnight shift work (≥1 night shift per week)
- Dependent on parenteral or enteral nutrition
- Pregnant or breastfeeding
- Active second malignancy requiring systemic therapy (exceptions: non-melanoma skin cancers or in situ cervical cancers adequately treated)
- Severe psychiatric, cognitive, or social conditions that would interfere with adherence to study procedures
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
Cedars Sinai Medical Center (CSMC)
Los Angeles, California, 90048
Jane Figueiredo, PhD, (310) 423-2746, Jane.Figueiredo@cshs.org
Jane Figueiredo, PhD
About this study
Official title: Effect of Meal Timing During Adjuvant Treatment for Cancer: A Randomized Clinical Trial
The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response, patient well-being and long-term metabolic health. In alignment with these priorities, we propose to focus on patients with histologically or cytologically confirmed solid tumors treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation per standard of care).
A promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.
Read the detailed description
Participants will be randomized to one of two groups:
- Time-restricted eating (TRE) (8-hour daily eating period, starting 1-3 hours after waking up), OR
- A control group defined as a ≥12-hour daily eating period.
Participants are assigned to either TRE (8-hour daily eating period, starting 1-3 hours after waking up) or a control group defined as a ≥12-hour daily eating period. Their randomized meal assignment arm begins no later than 1-2 week after they begin cancer treatment and ends at end of treatment (resection if indicated). This is a period of approximately 6 months.
During this time, participants will be asked to record the time they started and finished eating every day. Electronic reminders and weekly calls to the participants will be made by study staff who maintain records of patient's meal timing. Researchers will time the TRE schedules relative to sleep time (not time of day), which is a reasonable proxy for circadian time. The control group was designed to mimic typical eating habits in the U.S., as data from NHANES suggest that the median American eats over a 12.5-hour period each day. Aside from these general prescriptions, no set number of snacks, meals, or calories will be prescribed. Instead, researchers will measure how TRE affects self-reported mealtimes, meal frequency, and food intake through a combination of daily adherence surveys, 3-day food records and continuous glucose monitoring (CGM).
Participants will receive weekly one-on-one nutrition counseling during the first month and then monthly counseling sessions thereafter. Participants will complete questionnaires at intake and subsequent follow-up assessments. Blood and stool samples will also be collected from participants throughout the study.
- Conditions
- Cancer
- Being tested
- Time-restricted eating, Questionnaire Administration, Biospecimen Collection, Health coaching
- Keywords
- Time-restricted eating, Time restricted eating, Meal timing
- Medical subject headings
- Neoplasms, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
Participate in time-restricted eating plan
Questionnaire AdministrationOther
Complete questionnaire
Biospecimen CollectionProcedure or surgery
Undergo collection of blood and stool
Health coachingBehavioural
Receive nutrition counseling
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating (TRE) | Experimental | Participants assigned to the TRE group will have an 8-hour daily eating period, starting 1-3 hours after waking up [8 hours eating / 16 hours fasting per day (6+ days a week)]. Receives: Behavioral: Time-restricted eating; Other: Questionnaire Administration; Procedure: Biospecimen Collection; Behavioral: Health coaching |
| Control group | Active comparator | Participants assigned to the control group are not time-restricted, and have a 12+ hour window of eating per day. Receives: Other: Questionnaire Administration; Procedure: Biospecimen Collection; Behavioral: Health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported treatment-related toxicities: Average weekly scores
Assessed via Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE v5) toxicities, which is administered weekly throughout intervention and therapy; average scores calculated at each time point, timed to oncologic treatment cycles.
Measured: Assessed weekly from start of intervention through end of intervention (up to approximately 6 months)
Treatment Delivery: Relative dose intensity (RDI)
Relative dose intensity (RDI), defined as delivered/planned dose intensity, will be analyzed both as a continuous outcome (% of delivered vs planned) and as a binary outcome (≥85% vs. < 85%). Regimen-level RDI will be calculated as the average across drugs or based on the dose-limiting agent.
Measured: At end of intervention (at approximately 6 months)
Treatment Delivery: Number of patients completing planned adjuvant therapy without unplanned dose reductions or delays
Measured: At end of intervention (at approximately 6 monhts)
Secondary outcomes (23)
Clinician-reported CTCAE grade ≥3 toxicities
Measured: Baseline through end of intervention (at approximately 6 months)
Clinician-reported Toxicity Index
Measured: Baseline through end of intervention (at approximately 6 months)
Changes in quality of life (QOL): EORTC QLQ-C30
Change in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), a validated 30-item instrument measuring global health status/quality of life, functional domains (physical, role, emotional, cognitive, and social functioning), and symptom domains. Scores are linearly transformed to a 0-100 scale according to standard scoring guidelines. For global health status and functional scales, higher scores indicate better functioning or quality of life; for symptom scales, higher scores indicate greater symptom burden.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
PROMIS Anxiety
Change in anxiety measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form. Scores are standardized T-scores (mean = 50, standard deviation = 10). Higher scores indicate greater anxiety.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
PROMIS Fatigue
Change in fatigue measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue short form. Scores are standardized T-scores (mean = 50, standard deviation = 10). Higher scores indicate greater fatigue.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
PROMIS Physical Function
Change in physical function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form. Scores are standardized T-scores (mean = 50, standard deviation = 10). Higher scores indicate better physical function.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
UCLA Loneliness Scale
Change in perceived loneliness assessed using the UCLA Loneliness Scale. Scores are calculated by summing item responses, with higher scores indicating greater perceived loneliness.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Munich Chronotype Questionnaire (MCTQ)
Change in chronotype assessed using the Munich Chronotype Questionnaire. Chronotype is derived as mid-sleep time on free days, corrected for sleep debt (MSFsc), with later times indicating more evening preference.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Pittsburgh Sleep Quality Index (PSQI)
Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score is calculated from seven components, with higher scores indicating poorer sleep quality.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Appetite Questionnaire
Change in appetite assessed using a validated appetite questionnaire. Scores reflect patient-reported appetite levels, with higher scores indicating greater appetite (or specify direction if opposite).
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Dutch Eating Behavior Questionnaire (DEBQ)
Change in eating behaviors assessed using the Dutch Eating Behavior Questionnaire (DEBQ), including emotional eating, external eating, and restrained eating subscales. Higher scores indicate greater endorsement of the respective eating behavior.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Fasting Insulin
Change in fasting insulin levels measured from blood samples
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Fasting Glucose
Change in fasting glucose levels measured from blood samples.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
IGF-1
Change in circulating IGF-1 levels measured from blood samples.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Total Cholesterol
Change in total cholesterol levels measured from blood samples.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
LDL Cholesterol
Change in low-density lipoprotein (LDL) cholesterol levels measured from blood samples.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
HDL Cholesterol
Change in high-density lipoprotein (HDL) cholesterol levels measured from blood samples.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Triglycerides
Change in triglyceride levels measured from blood samples.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
C-Reactive Protein (CRP)
Change in CRP levels measured from blood samples as a marker of systemic inflammation.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Vitamin D
Change in circulating 25-hydroxyvitamin D levels measured from blood samples.
Measured: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Changes in sleep and physical activity patterns measured by wrist actigraphy
Sleep and physical activity patterns will be assessed using wrist actigraphy to measure parameters such as sleep duration, sleep timing, sleep efficiency, and activity levels.
Measured: Baseline and end of treatment (approximately 6 months)
Change in gut microbiome composition and diversity from stool samples
Change in stool-derived gut microbiome composition, including relative abundance of microbial taxa, and microbial diversity indices (e.g., alpha diversity such as Shannon index), measured using sequencing-based methods (e.g., 16S rRNA sequencing and metagenomics).
Measured: Baseline, mid-treatment (approximately 3 months), and end of treatment (approximately 6 months)
Changes in glucose patterns measured using continuous glucose monitoring (CGM)
Glucose levels will be continuously monitored using a wearable continuous glucose monitor to assess changes in glycemic patterns associated with the intervention.
Measured: Baseline and end of treatment (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start12 Aug 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Alaska Native Tribal Health Consortium, Alaska Native Medical Center, Cedars-Sinai Medical Center
- Responsible party
- Principal investigator, Jane Figueiredo, Cedars-Sinai Medical Center
- Investigators
- Jane Figueiredo, PhD, Principal investigator, Cedars-Sinai Medical CenterTimothy Thomas, MD, Principal investigator, Alaska Native Tribal Health Consortium (ANTHC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524218
- Sponsor's protocol ID
- RG1126131
- Other IDs
- 1P50CA285275-01A1, FHIRB21058
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Meal Timing During Adjuvant Treatment for Cancer: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07524218
- Acronym / sponsor ID
- RG1126131
- Conditions
- Cancer
- Keywords
- Time-restricted eating, Time restricted eating, Meal timing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Alaska Native Tribal Health Consortium, Alaska Native Medical Center, Cedars-Sinai Medical Center
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 13 Apr 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.
The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response, patient well-being and long-term metabolic health. In alignment with these priorities, we propose to focus on patients with histologically or cytologically confirmed solid tumors treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation per standard of care).
A promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.
Detailed description
Participants will be randomized to one of two groups:
- Time-restricted eating (TRE) (8-hour daily eating period, starting 1-3 hours after waking up), OR
- A control group defined as a ≥12-hour daily eating period.
Participants are assigned to either TRE (8-hour daily eating period, starting 1-3 hours after waking up) or a control group defined as a ≥12-hour daily eating period. Their randomized meal assignment arm begins no later than 1-2 week after they begin cancer treatment and ends at end of treatment (resection if indicated). This is a period of approximately 6 months.
During this time, participants will be asked to record the time they started and finished eating every day. Electronic reminders and weekly calls to the participants will be made by study staff who maintain records of patient's meal timing. Researchers will time the TRE schedules relative to sleep time (not time of day), which is a reasonable proxy for circadian time. The control group was designed to mimic typical eating habits in the U.S., as data from NHANES suggest that the median American eats over a 12.5-hour period each day. Aside from these general prescriptions, no set number of snacks, meals, or calories will be prescribed. Instead, researchers will measure how TRE affects self-reported mealtimes, meal frequency, and food intake through a combination of daily adherence surveys, 3-day food records and continuous glucose monitoring (CGM).
Participants will receive weekly one-on-one nutrition counseling during the first month and then monthly counseling sessions thereafter. Participants will complete questionnaires at intake and subsequent follow-up assessments. Blood and stool samples will also be collected from participants throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating (TRE) | Experimental | Behavioral: Time-restricted eating, Other: Questionnaire Administration, Procedure: Biospecimen Collection, Behavioral: Health coachingParticipants assigned to the TRE group will have an 8-hour daily eating period, starting 1-3 hours after waking up [8 hours eating / 16 hours fasting per day (6+ days a week)]. |
| Control group | Active comparator | Other: Questionnaire Administration, Procedure: Biospecimen Collection, Behavioral: Health coachingParticipants assigned to the control group are not time-restricted, and have a 12+ hour window of eating per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years (no upper age limit)
- Any sex or gender
- Histologically or cytologically confirmed solid tumor treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation per standard of care)
- BMI ≥18.5 kg/m2
- Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions
Key exclusion criteria (7 listed)
- No plan for systemic adjuvant therapy after surgery
- Strictly adhering to a <10-hour eating window on most days
- Regular overnight shift work (≥1 night shift per week)
- Dependent on parenteral or enteral nutrition
- Pregnant or breastfeeding
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 eatingParticipate in time-restricted eating plan | Behavioural | Time-restricted eating (TRE) |
| Questionnaire AdministrationComplete questionnaire | Other | Control group, Time-restricted eating (TRE) |
| Biospecimen CollectionUndergo collection of blood and stool | Procedure or surgery | Control group, Time-restricted eating (TRE) |
| Health coachingReceive nutrition counseling | Behavioural | Control group, Time-restricted eating (TRE) |
Primary outcome
Patient-reported treatment-related toxicities: Average weekly scores
Time frame: Assessed weekly from start of intervention through end of intervention (up to approximately 6 months)
Assessed via Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE v5) toxicities, which is administered weekly throughout intervention and therapy; average scores calculated at each time point, timed to oncologic treatment cycles.
Treatment Delivery: Relative dose intensity (RDI)
Time frame: At end of intervention (at approximately 6 months)
Relative dose intensity (RDI), defined as delivered/planned dose intensity, will be analyzed both as a continuous outcome (% of delivered vs planned) and as a binary outcome (≥85% vs. < 85%). Regimen-level RDI will be calculated as the average across drugs or based on the dose-limiting agent.
Treatment Delivery: Number of patients completing planned adjuvant therapy without unplanned dose reductions or delays
Time frame: At end of intervention (at approximately 6 monhts)
23 secondary outcomes
Clinician-reported CTCAE grade ≥3 toxicities
Time frame: Baseline through end of intervention (at approximately 6 months)
Clinician-reported Toxicity Index
Time frame: Baseline through end of intervention (at approximately 6 months)
Changes in quality of life (QOL): EORTC QLQ-C30
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
PROMIS Anxiety
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
PROMIS Fatigue
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
PROMIS Physical Function
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
UCLA Loneliness Scale
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Munich Chronotype Questionnaire (MCTQ)
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Appetite Questionnaire
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Dutch Eating Behavior Questionnaire (DEBQ)
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Fasting Insulin
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Fasting Glucose
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
IGF-1
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Total Cholesterol
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
LDL Cholesterol
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
HDL Cholesterol
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Triglycerides
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
C-Reactive Protein (CRP)
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Vitamin D
Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)
Changes in sleep and physical activity patterns measured by wrist actigraphy
Time frame: Baseline and end of treatment (approximately 6 months)
Change in gut microbiome composition and diversity from stool samples
Time frame: Baseline, mid-treatment (approximately 3 months), and end of treatment (approximately 6 months)
Changes in glucose patterns measured using continuous glucose monitoring (CGM)
Time frame: Baseline and end of treatment (approximately 6 months)
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 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Jane Figueiredo, PhD principal investigator
Cedars-Sinai Medical Center
Timothy Thomas, MD principal investigator
Alaska Native Tribal Health Consortium (ANTHC)
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, Questionnaire Administration and Biospecimen Collection in people with Cancer, run by Fred Hutchinson Cancer Center 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 5 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 25 Aug 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?
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 Jane Figueiredo, PhD ((310) 423-2746, Jane.Figueiredo@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported treatment-related toxicities: Average weekly scores (time frame: Assessed weekly from start of intervention through end of intervention (up to approximately 6 months)). The study lists 3 primary outcomes in all. 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 25 Aug 2026.