Colorectal CancerNCT04722341
Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
A study testing Time-Restricted Eating (TRE) in people with Colorectal Cancer and Breast Cancer, run by Cedars-Sinai Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to test whether the timing of meals can improve treatment adverse events, influence tumor biology and alter a person's mood and behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Breast Cancer
- What is being tested?
- Time-Restricted Eating (TRE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2022to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Any sex/gender of any ethnic/racial background
- Age greater than or equal to 18 years
- Histologically-confirmed rectal cancer stage II, III, or IV (if curative) or human epidermal growth factor receptor 2-positive (HER2+) or triple negative breast cancer stage I, II, or III (only if definitive intent) per American Joint Committee on Cancer (AJCC) criteria
- BMI 18.5 kg/m2 or greater
- Receiving either neoadjuvant therapy with curative intent (breast cancer patients) or total neoadjuvant therapy with a 5-fluorouracil-based regimen and curative intent (rectal cancer patients)
- Has completed ≤ 4 weeks of neoadjuvant treatment prior to study enrollment
- Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions
Who cannot join
- History of cytotoxic chemotherapy less than or equal to 12 months prior to rectal or breast cancer diagnosis
- Allergic reaction to any of the treatment agents
- Any prior pelvic radiotherapy
- Currently active second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ
- 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 congestive heart failure defined as ew York Heart Association Class (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
- Pregnant or breastfeeding
- Currently perform overnight shift work more than one day/week on average
- Strictly adhering to a <10-hour eating window on most days
- Known psychiatric or substance abuse disorders that would interfere with adhering to the requirements of the trial
- Medical condition or laboratory abnormality that could impact participant safety or data validity, in the opinion of the medical investigators.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Cedars-Sinai Medical Center
West Hollywood, California, 90048
About this study
The purpose of this study is to test whether the timing of meals can improve treatment adverse events, influence tumor biology and alter a person's mood and behaviors.
Read the detailed description
Combining fasting with chemotherapy is known to cause complete tumor regression and long-term survival in animal models. According to the Differential Stress Sensitization (DSS) theory, acute fasting sensitizes tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. These effects are believed to be largely mediated via the Insulin-like Growth Factor (IGF-1) pathway. However, extended fasting can be challenging for patients and poses undue health risks. A number of alternative intermittent fasting regimens have been proposed to overcome the challenges of prolonged caloric restriction. One promising approach is time-restricted eating (TRE), which involves eating within a period of 10 hours or less, followed by fasting for at least 14 hours daily. TRE does not involve extended caloric restriction, and because of its simplicity, it may be more sustainable than other fasting regimens. TRE improves several cardiometabolic endpoints independent of calorie restriction in both animals and humans, including insulin sensitivity, blood pressure, fat oxidation, and hunger. Our team's pilot and feasibility trials suggest that TRE may also have anti-cancer effects: it decreases IGF-1 levels, reduces oxidative stress, upregulates antioxidant defenses, and enhances autophagy. Moreover, our data suggest TRE is sustainable, as participants were adherent 6.0 plus or minus 0.8 days/week over a 14-week period. These findings lead to the following provocative question: Can TRE reduce treatment-related toxicity, induce tumor regression, and improve both patient-reported and clinical outcomes? We propose to conduct the largest randomized controlled trial of any form of intermittent fasting in patients undergoing cancer treatment. We focus on patients with localized rectal or breast cancer because it is one of the few treatment paradigms in which tumor characteristics can be measured before and after chemoradiation therapy.
- Conditions
- Colorectal Cancer, Breast Cancer
- Being tested
- Time-Restricted Eating (TRE), Control
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-Restricted Eating (TRE)Behavioural
8-hour daily eating period, starting 1-3 hours after waking up
ControlBehavioural
More than equal to a 12-hour daily eating period
| Study group | Role | What they receive |
|---|---|---|
| Time-Restricted Eating (TRE) | Experimental | 8-hour daily eating period. Participants eating window must start within 2 hours of waking up and no later than 9 am. Receives: Behavioral: Time-Restricted Eating (TRE) |
| Control | Active comparator | More than equal to a 12-hour daily eating period Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR) and Organ Preservation Rate
Measures whether participants achieve either a pathologic complete response (no invasive cancer is found in the removed tumor or sampled lymph nodes) or organ preservation at the end of treatment. For rectal cancer, organ preservation is defined as a complete or near-complete clinical response after therapy that allows the patient to safely avoid surgery, based on findings from exam, endoscopy, and MRI. Quantified as a percentage (%).
Measured: at end of 6-month intervention
Patient-Reported AEs (PRO-CTCAEs)
Adverse events as measured by the PRO-CTCAE (version 5), which includes about three dozen toxicities that patients can systematically document the frequency, severity (and interference of each toxicity).
Measured: at end of 6-month intervention
Secondary outcomes (4)
Clinical Response
Clinical response at end of treatment, categorized as: complete (no detectable disease on exam, endoscopy, or MRI); near-complete (minimal residual abnormality); partial (≥30% tumor decrease); stable disease; or progressive disease (≥20% tumor increase). We will also report the objective response rate (complete + near-complete + partial), percent with complete/near-complete responses, and percent with progressive disease. For breast cancer, responses may be estimated by physicians or MRI technicians. Values will also be expressed as percentages.
Measured: at end of 6-month intervention
Tumor Response
Different scales by cancer type. Rectal cancer, using MRI Tumor Regression Grade (1-5, with 1 = complete response) at end of treatment and the Neoadjuvant Rectal (NAR) score (0-100) at baseline and post-intervention. Breast cancer measured using the Residual Cancer Burden (RCB) score (0-4), where 0 indicates a pathologic complete response.
Measured: at end of 6 month intervention
Provider-Reported AEs (Treatment Related Toxicities)
Measures treatment-related adverse events (AEs) reported by providers from the start of therapy to the day before surgery. AEs are graded using CTCAE v5, and we will report totals as well as Grade 1-2 and Grade 3-4 events. The Toxicity Index (TI) will also be calculated, which ranges from 0 to 5.83.
Measured: at end of 6 month intervention
Health-Related Quality of Life
Assessed at each testing visit using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (EORTC QLQ-C30) for all participants, the QLQ-breast cancer 23 (QLQ-BR32) for breast cancer, and the QLQ-rectal cancer 29 (QLQ-CR29) for rectal cancer. All scales are scored from 0-100, with higher functional and global health scores indicating better quality of life and higher symptom scores indicating worse symptoms. The QLQ-C30 includes five functional scales, three symptom scales, and a global quality-of-life scale, while the BR23 and CR29 include cancer-specific functional and symptom scales.
Measured: at end of 6 month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Jan 2022
- Primary completion31 Jul 2026
- Study completion31 Aug 2026
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 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Alabama at Birmingham, Harvard University
- Responsible party
- Principal investigator, Sarah Salvy, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722341
- Sponsor's protocol ID
- 15494
- Other IDs
- 1R01CA258222-01
- Status last verified
- Oct 2026
- First submitted
- 14 Dec 2020
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salvy SJ, Figueiredo JC, Atkins KM, Hollis RH, Jahan N, Gunnells DJ, Sleight AG, Gresham G, Diniz MA, Richman JS, Gong J, Zaghiyan K, Heslin MJ, Lee KJ, Sarfraz H, Peterson CM. The CHRONO trial: Protocol for a randomized controlled trial of early time-restricted eating in patients with breast or rectal cancer. Nutr Res. 2026 Jul;151:77-94. doi: 10.1016/j.nutres.2026.04.016. Epub 2026 May 2.
PubMed 42190452
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators
- ClinicalTrials.gov ID
- NCT04722341
- Acronym / sponsor ID
- 15494
- Conditions
- Colorectal Cancer, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Alabama at Birmingham, Harvard University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 25 Jan 2021 (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 purpose of this study is to test whether the timing of meals can improve treatment adverse events, influence tumor biology and alter a person's mood and behaviors.
Detailed description
Combining fasting with chemotherapy is known to cause complete tumor regression and long-term survival in animal models. According to the Differential Stress Sensitization (DSS) theory, acute fasting sensitizes tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. These effects are believed to be largely mediated via the Insulin-like Growth Factor (IGF-1) pathway. However, extended fasting can be challenging for patients and poses undue health risks. A number of alternative intermittent fasting regimens have been proposed to overcome the challenges of prolonged caloric restriction. One promising approach is time-restricted eating (TRE), which involves eating within a period of 10 hours or less, followed by fasting for at least 14 hours daily. TRE does not involve extended caloric restriction, and because of its simplicity, it may be more sustainable than other fasting regimens. TRE improves several cardiometabolic endpoints independent of calorie restriction in both animals and humans, including insulin sensitivity, blood pressure, fat oxidation, and hunger. Our team's pilot and feasibility trials suggest that TRE may also have anti-cancer effects: it decreases IGF-1 levels, reduces oxidative stress, upregulates antioxidant defenses, and enhances autophagy. Moreover, our data suggest TRE is sustainable, as participants were adherent 6.0 plus or minus 0.8 days/week over a 14-week period. These findings lead to the following provocative question: Can TRE reduce treatment-related toxicity, induce tumor regression, and improve both patient-reported and clinical outcomes? We propose to conduct the largest randomized controlled trial of any form of intermittent fasting in patients undergoing cancer treatment. We focus on patients with localized rectal or breast cancer because it is one of the few treatment paradigms in which tumor characteristics can be measured before and after chemoradiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-Restricted Eating (TRE) | Experimental | Behavioral: Time-Restricted Eating (TRE)8-hour daily eating period. Participants eating window must start within 2 hours of waking up and no later than 9 am. |
| Control | Active comparator | Behavioral: ControlMore than equal to a 12-hour daily eating period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Any sex/gender of any ethnic/racial background
- Age greater than or equal to 18 years
- Histologically-confirmed rectal cancer stage II, III, or IV (if curative) or human epidermal growth factor receptor 2-positive (HER2+) or triple negative breast cancer stage I, II, or III (only if definitive intent) per American Joint Committee on Cancer (AJCC) criteria
- BMI 18.5 kg/m2 or greater
- Receiving either neoadjuvant therapy with curative intent (breast cancer patients) or total neoadjuvant therapy with a 5-fluorouracil-based regimen and curative intent (rectal cancer patients)
Key exclusion criteria (15 listed)
- History of cytotoxic chemotherapy less than or equal to 12 months prior to rectal or breast cancer diagnosis
- Allergic reaction to any of the treatment agents
- Any prior pelvic radiotherapy
- Currently active second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ
- 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 Eating (TRE)8-hour daily eating period, starting 1-3 hours after waking up | Behavioural | Time-Restricted Eating (TRE) |
| ControlMore than equal to a 12-hour daily eating period | Behavioural | Control |
Primary outcome
Pathologic Complete Response (pCR) and Organ Preservation Rate
Time frame: at end of 6-month intervention
Measures whether participants achieve either a pathologic complete response (no invasive cancer is found in the removed tumor or sampled lymph nodes) or organ preservation at the end of treatment. For rectal cancer, organ preservation is defined as a complete or near-complete clinical response after therapy that allows the patient to safely avoid surgery, based on findings from exam, endoscopy, and MRI. Quantified as a percentage (%).
Patient-Reported AEs (PRO-CTCAEs)
Time frame: at end of 6-month intervention
Adverse events as measured by the PRO-CTCAE (version 5), which includes about three dozen toxicities that patients can systematically document the frequency, severity (and interference of each toxicity).
4 secondary outcomes
Clinical Response
Time frame: at end of 6-month intervention
Tumor Response
Time frame: at end of 6 month intervention
Provider-Reported AEs (Treatment Related Toxicities)
Time frame: at end of 6 month intervention
Health-Related Quality of Life
Time frame: at end of 6 month intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 42190452Salvy SJ, Figueiredo JC, Atkins KM, Hollis RH, Jahan N, Gunnells DJ, Sleight AG, Gresham G, Diniz MA, Richman JS, Gong J, Zaghiyan K, Heslin MJ, Lee KJ, Sarfraz H, Peterson CM. The CHRONO trial: Protocol for a randomized controlled trial of early time-restricted eating in patients with breast or rectal cancer. Nutr Res. 2026 Jul;151:77-94. doi: 10.1016/j.nutres.2026.04.016. Epub 2026 May 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 (TRE) in people with Colorectal Cancer and Breast Cancer, run by Cedars-Sinai Medical Center at 2 sites 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 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: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) and Organ Preservation Rate (time frame: at end of 6-month intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722341, 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 29 Oct 2026.