Could prepared meals help colorectal cancer patients eat healthier?

NCT ID NCT07701707

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This pilot study tests whether providing medically tailored meals and fresh produce can help people with stage I-III colorectal cancer eat fewer ultra-processed foods. Participants are randomly assigned to receive fully prepared meals, meals plus fresh produce, or meal-planning materials only for six weeks. The study evaluates how feasible and acceptable this approach is and whether it improves diet, quality of life, and health outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
medically tailored meals and fresh produce
What this could lead to
If successful, this approach could offer a practical way to improve diet and quality of life for colorectal cancer survivors.
What could go wrong
This is a small pilot study focused on feasibility, so results may not be conclusive or generalizable to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must have histologically confirmed stage I, II, or III colon or rectal adenocarcinoma and have completed standard treatment (including surgery, chemotherapy, and radiotherapy) at least 2 months ago. * Age ≥18 years. * ECOG = 0 or 1 * Participants must have a high intake of UPFs, defined as meeting at least three of the following criteria, each consumed on more than or equal to 3 days per week: * Ready-to-eat or ready-to-heat dishes, such as packaged frozen meals, prepared entrées, quick dishes, or microwaveable packaged foods; * Sugar- or artificially sweetened beverages (e.g., soda, diet coke, sweetened teas, bubble tea, flavored instant coffee mixes), alcoholic beverages, or other commercially prepared sweetened drinks; * Packaged snack foods, such as chips, cookies, ice cream, desserts, or other commercially prepared snack items; * Frequent fast-food consumption, including meals or beverages purchased from fast-food or quick-service restaurants, such as McDonald's, Wendy's, KFC, Burger King, Five Guys, Chick-fil-A, Dairy Queen, etc. * Home-cooked meals that rely primarily on pre-prepared ingredients, such as deli meats, canned fish, canned fruits and vegetables, frozen foods or ingredients, or similar products used more often than fresh produce, raw meat/seafood, or raw fruits and vegetables. * Subjects must be able and willing to follow study procedures and instructions. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants who are receiving any other investigational agents or lifestyle/dietary interventions. * Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol. * Any prior diagnosis of invasive (i.e., excluding intramucosal cancer) gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (except non-melanoma skin) in which there has been any active treatment within the last three years. * Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment. * Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection. * Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results. * Participants who are pregnant Participants who may become pregnant or partners of those who may become pregnant while on study will receive contraception counseling. Participants or partners of those who become pregnant while participating in the study should immediately inform their doctor. * Participants who are unwilling to make dietary changes. * Individuals who do not have access to or are not able to participate in remote nutrition counseling and assessment sessions via Zoom or phone calls.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

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