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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed rectal cancer stage II or III per AJCC criteria
Plan to receive either neoadjuvant conventional chemoradiation or total neoadjuvant therapy (TNT) with 5-fluorouracil-based regimens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at end of 6 month intervention
Awards & highlights
Study Summary
This trial will test the effects of different meal times on cancer patients' treatment, tumor growth, mood, and behavior.
Who is the study for?
This trial is for adults aged 21+ with stage II or III rectal cancer who plan to receive specific chemotherapy and radiation treatments. They must have a BMI of at least 18.5, be able to follow the study's schedule, and have good organ function. Excluded are those with recent cancers or treatments, certain health conditions like uncontrolled hypertension, active second malignancies (except some skin cancers), severe allergies to treatment agents, unstable psychiatric disorders, or women who are pregnant/breastfeeding.Check my eligibility
What is being tested?
The study examines if time-restricted eating (TRE) can improve side effects from cancer treatment, affect tumor biology and change mood/behavior in patients with colorectal cancer. Participants will either follow TRE guidelines or continue their normal diet (control group) while undergoing standard cancer therapies.See study design
What are the potential side effects?
Since this trial focuses on meal timing rather than medication or invasive procedures, direct side effects from interventions may not be as pronounced as typical drug trials. However, changes in diet patterns could potentially cause digestive discomforts such as bloating or constipation and impact energy levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My rectal cancer is confirmed to be stage II or III.
Select...
I am planning to undergo chemoradiation or total therapy with a specific drug before surgery.
Select...
I am 21 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at end of 6 month intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at end of 6 month intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient-reported outcomes (PROs)
Treatment Related Toxicities
Secondary outcome measures
Dietary Intake
Mood
Physical Activity
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Time-Restricted Eating (TRE)Experimental Treatment1 Intervention
8-hour daily eating period, starting 1-3 hours after waking up
Group II: ControlActive Control1 Intervention
More than equal to a 12-hour daily eating period
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,729 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,590 Previous Clinical Trials
2,281,182 Total Patients Enrolled
Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
164,563 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that affects my stomach or intestines, like constant vomiting or diarrhea.You usually eat all your meals within 11 hours or less every day.I have ongoing symptoms from a bowel disorder.My organs and bone marrow are functioning well.My blood pressure is not controlled by medication.I have severe nerve damage.I have not had a GI perforation in the last year.You have mental health or drug addiction issues that could make it difficult to follow the trial requirements.My rectal cancer is confirmed to be stage II or III.I have severe heart failure that is not well-managed.I will not travel across more than three time zones during the study.I have not had major surgery within the last 4 weeks or minor surgery within the last week.I am planning to undergo chemoradiation or total therapy with a specific drug before surgery.I had chemotherapy or radiation for cancer less than a year before my rectal cancer appeared.You are allergic to any of the medicines being used in the study.I am 21 years old or older.I have had radiation or chemoradiation therapy in the pelvic area before.My gender or ethnic background does not limit my participation.You are either pregnant or nursing a baby.I have not had significant bleeding or clotting events in the last 6 months.I have another active cancer besides non-melanoma skin cancer or cervical carcinoma in situ.You have a body mass index (BMI) of at least 18.5 kg/m2.My mental health and sleep conditions are stable and not worsening.I am using tube feeding or nutritional supplements.
Research Study Groups:
This trial has the following groups:- Group 1: Time-Restricted Eating (TRE)
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have enrolled in this medical experiment?
"Affirmative. Information accessible on clinicaltrials.gov affirms that this medical trial is actively recruiting subjects, with the initial post being made on January 1st 2022 and last updated April 20th 2022. The study seeks to recruit 300 patients from a single location."
Answered by AI
Is the team still accepting participants for this trial?
"Affirmative. Clinicaltrials.gov reveals that this research, which was posted for the first time on January 1st 2022, is open to new enrollees. 300 individuals are required from one medical centre in order to complete the trial."
Answered by AI
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