Time-Restricted Eating for Rectal Cancer

Overseen By Timothy Thomas, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Must be taking: 5-fluorouracil

Disqualifiers: Second malignancy, Uncontrolled CHF, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating (TRE) can improve treatment outcomes and metabolic health for people with rectal cancer. Participants will either follow a TRE schedule, eating only during an 8-hour window each day, or maintain a normal eating pattern. The researchers aim to determine if TRE can enhance the effectiveness of cancer treatments and reduce side effects. Ideal candidates are Alaska Native or American Indian individuals receiving cancer treatment at the Alaska Native Medical Center with stage II or III rectal cancer. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance cancer treatment strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it is important to discuss your medications with the trial team to ensure they do not interfere with the study.

What prior data suggests that time-restricted eating is safe for rectal cancer patients?

Previous studies have shown that time-restricted eating (TRE) is safe for adults. TRE involves eating only during specific hours each day, such as an 8-hour window, and fasting the rest of the time. Research indicates that many people can adhere to this eating pattern, with success rates ranging from 67% to 98%, suggesting it is easy for most to maintain.

Some studies also demonstrate that TRE can aid in weight loss and improve quality of life. Importantly, there are no major reports of harmful side effects from TRE. It has been tested in individuals with obesity and various health conditions, yielding positive results. These findings suggest that TRE is a safe option for managing health, particularly during cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating (TRE) for rectal cancer because it offers a non-invasive approach that could complement existing treatments like surgery, chemotherapy, and radiation. Unlike these standard options, TRE focuses on when you eat, not what you eat, using an 8-hour daily eating window followed by 16 hours of fasting. This method might enhance the body's natural repair mechanisms and improve metabolic health, potentially making cancer cells more vulnerable to traditional treatments. By exploring how timing affects cancer growth, TRE could revolutionize dietary guidelines for cancer care.

What evidence suggests that time-restricted eating might be an effective treatment for rectal cancer?

This trial will compare time-restricted eating (TRE) with a control group for rectal cancer treatment. Research has shown that TRE might aid in cancer treatment. Animal studies demonstrated that TRE can protect against cancer. In humans, TRE is safe and can assist with weight loss. Early results suggest that TRE may enhance the effectiveness of cancer treatments and improve quality of life. TRE involves eating only during a specific part of the day, which might be easier to follow than other fasting methods. This approach could help the body respond better to cancer treatments. ^{3 4 6 7 8}

Who Is on the Research Team?

Timothy Thomas, MD

Principal Investigator

Alaska Native Tribal Health Consortium (ANTHC)

Jane Figueiredo, PhD, M.Sc.

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for Alaska Native patients with rectal cancer who are undergoing neoadjuvant treatment. It aims to explore if eating meals within a set time frame each day can improve the effectiveness of their cancer treatment and overall health.

Inclusion Criteria

I am either male or female.

Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions

My rectal cancer is confirmed to be stage II or III.

Exclusion Criteria

I have a condition that affects my stomach or intestines, like constant vomiting or diarrhea.

Regularly eat within an <11-hour period each day

History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation in the trial, or is not in the best interest of the participant to participate, in the opinions of the treating investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant treatment with a focus on time-restricted eating (TRE) or a control eating schedule

6 months

Weekly one-on-one nutrition counseling during the first month, then monthly counseling sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of clinical and pathological responses

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time-restricted eating

Trial Overview The study tests time-restricted eating (TRE), where participants eat during an 8-hour window and fast for the remaining day, alongside regular cancer treatments. The trial also includes health coaching, questionnaires, and biospecimen collection to assess outcomes.

How Is the Trial Designed?

Group I: Time-restricted eating (TRE) Experimental Treatment 4 Interventions

Participants assigned to the TRE group will have an 8-hour daily eating period, starting 1-3 hours after waking up \[8 hours eating / 16 hours fasting per day (6+ days a week)\].

Group II: Control group Active Control 3 Interventions

Participants assigned to the control group are not time-restricted, and have a 12+ hour window of eating per day.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

Alaska Native Tribal Health Consortium

Collaborator

Trials

20

Recruited

9,600+

Alaska Native Medical Center

Collaborator

Trials

4

Recruited

810+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9691536/

The basis and design for time‐restricted eating compared ... TRE in animals shows cancer protective effects. In humans, TRE is safe and acceptable among adults with obesity, producing ~3% to 5% weight loss ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05722288

NCT05722288 | Time-Restricted Eating Versus Nutritional ... This phase II trial studies how well time-restricted eating works in reducing side effects of radiation or chemoradiation side effects when compared to ...

3. academic.oup.com academic.oup.com/nutritionreviews/article/83/7/e1660/7745808

Clinical Impact of Time-restricted Eating on Cancer Preliminary findings suggest that TRE is feasible and acceptable by people with cancer, may have oncological benefits, and improves quality of life.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06802172/effect-of-time-restricted-eating-during-cancer-treatment-in-alaska-native-patients-with-rectal-cancer

Effect of Time-Restricted Eating During Cancer Treatment ... Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-04263

Time-restricted Eating Versus Daily Continuous Calorie ... This research will demonstrate that time-restricted eating, a type of intermittent fasting, is an effective therapy to help obese individuals reduce and control ...

6. reporter.nih.gov reporter.nih.gov/project-details/10851964

Time-Restricted Eating and Cancer: Clinical Outcomes, ... Because of its simplicity, TRE may be more sustainable. Moreover, our pilot data suggest that TRE has several anti-cancer effects: it decreases IGF-1 levels, ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/41/NCT04722341/Prot_SAP_000.pdf

Time-Restricted Eating and Cancer The purpose of this study is to test whether the timing of meals can improve treatment-related adverse events, influence tumor biology, ...

8. trialx.com trialx.com/clinical-trials/listings/238662/time-restricted-eating-versus-daily-continuous-calorie-restriction-on-body-weight-and-colorectal-cancer-risk-markers/

Time-restricted Eating Versus Daily Continuous Calorie ... Time-restricted eating, a type of intermittent fasting, has been shown in animals to impart cancer protective effects including lower body ...