Rectal Cancer Stage IINCT06802172
Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial
A study testing Time-restricted eating, Questionnaire Administration and Biospecimen Collection in people with Rectal Cancer Stage II and Rectal Cancer Stage III, 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 and metabolic health in an understudied population. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Rectal Cancer Stage II, Rectal Cancer Stage III, Breast Cancer Stage I
- 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
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Self-identify as Alaska Native or American Indian person and eligible for care at the ANMC
- Age≥21 years
- Histologically confirmed rectal cancer stage II, III, or IV (if curative) per AJCC criteria (neoadjuvant)
- Histologically confirmed HER2+ or triple negative breast cancer stage I, II, or III, per AJCC criteria (neoadjuvant)
- Histologically or cytologically confirmed solid tumor (adjuvant)
Show all 13Show fewer
- BMI≥18.5 kg/m2
- Plan to receive neoadjuvant or adjuvant therapy
- Planned duration of neoadjuvant or systemic adjuvant therapy for >3 months to allow sufficient time to assess impact of intervention
- Must have capacity to give informed consent
- Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions
- Has completed ≤ 4 weeks of neoadjuvant or adjuvant treatment prior to study enrollment
- Score of < 4 on U.S. Household Food Security Survey Module: Six-Item Short Form OR if score >5, have clearance from dietitian
Who cannot join
- History of cytotoxic chemotherapy ≤12 months prior to rectal or breast cancer diagnosis (neoadjuvant)
- Allergic reaction to any of the treatment agents
- Any prior pelvic radiotherapy
- Active second malignancy (exceptions: non-melanoma skin cancers or cervical carcinoma in situ adequately treated) requiring systemic therapy
- History of GI perforation ≤12 months prior to enrollment
- History of predisposing colonic or small bowel disorders with severe or rapidly worsening symptoms (not related to current cancer symptoms)
Show all 15Show fewer
- Receiving any parenteral nutrition or enteral (tube) feeding or using similar nutritional supplement during the study period
- History of uncontrolled CHF defined as NYHA Class III or greater
- Pre-existing grade ≥3 neuropathy
- Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment
- Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
- Pregnant or breastfeeding
- Currently perform overnight shift work >1 day/week
- Strictly adhering to a <10-hour eating window on most days
- Severe psychiatric, cognitive, or substance misuse disorders 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
Alaska Native Medical Center (ANMC)
Anchorage, Alaska, 99508
Timothy Thomas, MD, (907) 729-3095, tkthomas@anthc.org
Timothy Thomas, MD
About this study
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 and metabolic health in an understudied population. This clinical trial will enroll patients with rectal or breast cancer receiving neoadjuvant treatment at the Alaska Native Medical Center (ANMC), which is part of the Alaska Native Tribal Health Consortium (ANTHC).
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
- Rectal Cancer Stage II, Rectal Cancer Stage III, Breast Cancer Stage I, Rectal Cancer Stage IV, Breast Cancer Stage II, Breast Cancer Stage III
- Being tested
- Time-restricted eating, Questionnaire Administration, Biospecimen Collection, Health coaching
- Keywords
- Time-restricted eating, Time restricted eating, Meal timing
- Medical subject headings
- Rectal Neoplasms, Breast 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.
Pathological Complete Response (pCR) rate
The pCR will be defined as an absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected rectal or breast specimen and all sampled regional lymph nodes. It will be treated as a binary variable.
Measured: At completion of neoadjuvant treatment (3-6 months)
Treatment-related toxicity
The Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE v.5) measurement system will be used to measure treatment-related toxicities. The PRO-CTCAE will be administered on a weekly basis throughout the intervention and will calculate the average over all items for each time point. Surveys will be timed relative to the start of each oncologic treatment segment.
Measured: From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)
Treatment Delivery (RDI and Completion)
Chemotherapy, targeted therapy, immunotherapy and/or radiation data will be abstracted to calculate relative dose intensity (RDI--delivered ÷ planned dose intensity, mg/m²/week) for each drug, expressed continuously and dichotomized at ≥85%. Regimen-level RDI will be calculated as the average across drugs or based on the dose-limiting agent. We will also calculate the proportion of participants completing all planned cycles without unplanned reductions or delays.
Measured: From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)
Secondary outcomes (10)
Clinical Complete Response (cCR)
A cCR will be defined as the clinical absence of residual disease on physical examination, endoscopic examination, and/or repeat MRI imaging following completion of total neoadjuvant treatment.
Measured: At completion of neoadjuvant treatment (3-6 months)
Tumor volume
Standard of care CT and MRI images will be obtained at the time of diagnosis for staging. A repeat standard of care MRI imaging may be obtained prior to surgery to assess response to neoadjuvant therapy and to guide clinical and surgical management. Researchers will obtain routine clinical restaging scans from participants and use them to estimate changes in tumor volume between the two time points.
Measured: From baseline to surgery (3-6 months)
Objective response rate (ORR)
The ORR is defined as the percentage of people who have a partial response (defined as a decrease in tumor volume) or a complete response to treatment between enrollment and surgery.
Measured: At the time of surgery following neoadjuvant treatment completion (3-6 months)
Neoadjuvant rectal (NAR) score
The NAR score is a validated surrogate endpoint for oncologic outcomes used in rectal cancer clinical trials. It takes as input the pathologic nodal status and the clinical and pathologic T-stage.
Measured: At completion of neoadjuvant treatment for rectal cancer (3-6 months)
Provider-reported adverse events
As secondary measures of toxicity, researchers will collect provider-reported adverse event data. Researchers will analyze the incidence of grade 3-4 toxicities and calculate the aggregated Toxicity Index (TI). The TI accounts for the frequency and cumulative burden of all toxicities during the treatment period.
Measured: From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)
Health-related quality of life (HR-QOL)
We will use the widely-used and validated European Organization for Research and Treatment of Cancer Quality of Life (QOL) core questionnaire C30 (EORTC QLQ-C30), the colorectal-cancer specific questionnaire (EORTC CR29), and the breast cancer specific questionnaire (PR_BR23). For this study, we focus on highly prevalent rectal and breast cancer treatment-related symptoms, including fatigue, insomnia, pain and bowel-related items (stool frequency, flatulence, and fecal incontinence).
Measured: From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)
Adherence
Adherence will be defined as at least 70% of the daily regimen followed (for example, eating <8 hours for 6 or more days per week on average during the 6-month treatment period). Participants will be asked to self-report their adherence using a weekly survey, which asks participants to record the time they start and finish eating each day and to document any reasons for non-adherence.
Measured: From enrollment until completion of study participation (3-8 months)
Progression-free survival (PFS)
Progression-free survival (PFS) is the length of time from randomization to disease progression or death from any cause.
Measured: 12- and 24 months post completion of neoadjuvant treatment and surgery or adjuvant treatment.
Relapse-free survival (RFS)
Relapse-free survival (RFS) is the length of time after primary cancer treatment ends that a patient survives without any signs or symptoms of that cancer.
Measured: 12- and 24 months post completion of neoadjuvant treatment and surgery or adjuvant treatment.
Overall survival (OS)
Overall survival (OS) is the time from randomization to death from any cause.
Measured: 12- and 24 months post completion of neoadjuvant treatment and surgery or adjuvant treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start23 Jul 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 Rectal Cancer Stage IIStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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, Timothy Thomas, MD, Alaska Native Tribal Health Consortium
- Investigators
- Timothy Thomas, MD, Principal investigator, Alaska Native Tribal Health Consortium (ANTHC)Jane Figueiredo, PhD, M.Sc., Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802172
- Sponsor's protocol ID
- RG1124486
- Other IDs
- 1P50CA285275-01A1, 2111923-7
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2025
- Last updated
- 29 Jul 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06802172
- Acronym / sponsor ID
- RG1124486
- Conditions
- Rectal Cancer Stage II, Rectal Cancer Stage III, Breast Cancer Stage I, Rectal Cancer Stage IV, Breast Cancer Stage II, Breast Cancer Stage III
- Keywords
- Time-restricted eating, Time restricted eating, Meal timing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 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
- 23 Jul 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 31 Jan 2025 (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 and metabolic health in an understudied population. This clinical trial will enroll patients with rectal or breast cancer receiving neoadjuvant treatment at the Alaska Native Medical Center (ANMC), which is part of the Alaska Native Tribal Health Consortium (ANTHC).
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
- Other
- 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
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female
- Self-identify as Alaska Native or American Indian person and eligible for care at the ANMC
- Age≥21 years
- Histologically confirmed rectal cancer stage II, III, or IV (if curative) per AJCC criteria (neoadjuvant)
- Histologically confirmed HER2+ or triple negative breast cancer stage I, II, or III, per AJCC criteria (neoadjuvant)
Key exclusion criteria (15 listed)
- History of cytotoxic chemotherapy ≤12 months prior to rectal or breast cancer diagnosis (neoadjuvant)
- Allergic reaction to any of the treatment agents
- Any prior pelvic radiotherapy
- Active second malignancy (exceptions: non-melanoma skin cancers or cervical carcinoma in situ adequately treated) requiring systemic therapy
- History of GI perforation ≤12 months prior to enrollment
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
Pathological Complete Response (pCR) rate
Time frame: At completion of neoadjuvant treatment (3-6 months)
The pCR will be defined as an absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected rectal or breast specimen and all sampled regional lymph nodes. It will be treated as a binary variable.
Treatment-related toxicity
Time frame: From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)
The Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE v.5) measurement system will be used to measure treatment-related toxicities. The PRO-CTCAE will be administered on a weekly basis throughout the intervention and will calculate the average over all items for each time point. Surveys will be timed relative to the start of each oncologic treatment segment.
Treatment Delivery (RDI and Completion)
Time frame: From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)
Chemotherapy, targeted therapy, immunotherapy and/or radiation data will be abstracted to calculate relative dose intensity (RDI--delivered ÷ planned dose intensity, mg/m²/week) for each drug, expressed continuously and dichotomized at ≥85%. Regimen-level RDI will be calculated as the average across drugs or based on the dose-limiting agent. We will also calculate the proportion of participants completing all planned cycles without unplanned reductions or delays.
10 secondary outcomes
Clinical Complete Response (cCR)
Time frame: At completion of neoadjuvant treatment (3-6 months)
Tumor volume
Time frame: From baseline to surgery (3-6 months)
Objective response rate (ORR)
Time frame: At the time of surgery following neoadjuvant treatment completion (3-6 months)
Neoadjuvant rectal (NAR) score
Time frame: At completion of neoadjuvant treatment for rectal cancer (3-6 months)
Provider-reported adverse events
Time frame: From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)
Health-related quality of life (HR-QOL)
Time frame: From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)
Adherence
Time frame: From enrollment until completion of study participation (3-8 months)
Progression-free survival (PFS)
Time frame: 12- and 24 months post completion of neoadjuvant treatment and surgery or adjuvant treatment.
Relapse-free survival (RFS)
Time frame: 12- and 24 months post completion of neoadjuvant treatment and surgery or adjuvant treatment.
Overall survival (OS)
Time frame: 12- and 24 months post completion of neoadjuvant treatment and surgery or adjuvant treatment.
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 29 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer Stage II
RecruitingPhase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma
RecruitingPhase 2
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
Rectal Adenocarcinoma, Clinical Stage: Stage II (T3-4, N-)
Recruiting
Family Communications After Genetic Testing
Colon Adenocarcinoma, Colorectal Adenocarcinoma
Active, not recruitingPhase 2
Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer
Locally Advanced Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8
Active, not recruitingPhase 2
Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
Localized Prostate Carcinoma, Locally Advanced Cervical Carcinoma
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.
Timothy Thomas, MD principal investigator
Alaska Native Tribal Health Consortium (ANTHC)
Jane Figueiredo, PhD, M.Sc. principal investigator
Cedars-Sinai Medical Center
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 Rectal Cancer Stage II and Rectal Cancer Stage III, 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 13 inclusion and 15 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 29 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?
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 Timothy Thomas, MD ((907) 729-3095, tkthomas@anthc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) rate (time frame: At completion of neoadjuvant treatment (3-6 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 29 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.