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

100 Participants Needed

Trial Summary

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.

How does time-restricted eating differ from other treatments for rectal cancer?

Time-restricted eating is unique because it focuses on limiting the hours during which food is consumed each day, rather than altering the type or amount of food. This approach is different from traditional treatments like surgery or chemotherapy, as it aims to potentially improve health outcomes by aligning eating patterns with the body's natural circadian rhythms. ^{1 2 3 4 5}

What is the purpose of this 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 and metabolic health in an understudied population. This clinical trial will enroll patients with rectal 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.

Research Team

Timothy Thomas, MD

Principal Investigator

Alaska Native Tribal Health Consortium (ANTHC)

Jane Figueiredo, PhD, M.Sc.

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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.

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

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Reported behavior of eating anything at anytime and risk of colorectal cancer in women. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Nutritional Counseling Protocol for Colorectal Cancer Patients after Surgery Improves Outcome. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Colorectal cancer: intrinsic characteristics modulate cancer energy expenditure and the risk of cachexia. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

The joint association of eating frequency and diet quality with colorectal cancer risk in the Health Professionals Follow-up Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Dietary intake and nutritional indicators are transiently compromised during radiotherapy for rectal cancer. [2006]