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Medically Tailored Meals to Reduce Ultra-processed Food Intake in Colorectal Cancer Survivors (MTM)

8 luglio 2026 aggiornato da: Mengxi Du, Massachusetts General Hospital

A Pilot Medically Tailored Meal-Based Intervention to Reduce Ultra-processed Food Intake Among Patients With Stages I-III Colorectal Cancer

This research study is a three-arm, parallel-group randomized clinical trial that examines the feasibility and initial impact of consuming medically tailored meals to reduce intake of ultra-processed food and improve health and survival outcomes among 60 patients with stage I-III colorectal cancer.

Panoramica dello studio

Descrizione dettagliata

This research study is exploring whether medically tailored meals can help survivors with stage I-III colorectal cancer reduce their intake of ultra-processed foods and improve their health. Ultra-processed foods, such as packaged snacks, fast food, and sugary drinks, make up a large portion of many Americans' diets and have been linked to a higher risk of colorectal cancer and poorer survival. While experts recommend limiting these foods, many patients face challenges like limited time, cooking skills, or access to healthy options, making dietary changes difficult.

Medically tailored meals, designed by dietitians to meet specific health needs, may offer a practical solution by making healthy eating easier and more accessible. This study will evaluate whether these meals, with or without fresh produce, can improve diet quality, support healthier gut bacteria, and reduce inflammation. Researchers will measure changes in gut health and blood markers before and after the program to better understand how diet can influence recovery and long-term outcomes for colorectal cancer survivors.

This research study will last about 3 years. It includes a 2-week preparation period, a 6-week intervention with a medically tailored meals (MTM) program, 2 clinic visits (one prior to starting and one following the 6-week intervention period), 2 nutrition counseling visits with a registered dietitian (also conducted before and after the intervention), and follow-up contacts (4 weeks after the final visit and then every year for 3 years).

Because it is unknown which meal plan is best, participants will be randomized to one of these 3 meal plan groups:

  • MTM: participants will receive 3 fully prepared, home-delivered, medically tailored meals per day for 6 weeks.
  • MTM plus Fresh Produce: participants will receive 2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks.
  • Control group: participants will receive weekly recipes and meal-planning materials only; no food will be provided.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
        • Massachusetts General Hospital
        • Contatto:
        • Investigatore principale:
          • Mengxi Du, RD, PhD, MPH

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Medically Tailored Meals (MTM)
3 prepared meals per day (i.e., breakfast, lunch, and dinner) for a total of 126 meals.
3 fully prepared, home-delivered, medically tailored meals per day delivered weekly for 6 weeks.
Sperimentale: Medically Tailored Melas (MTM) plus Fresh Produce
2 prepared meals per day (84 meals total), plus weekly fresh produce and recipes to help prepare a third meal each day.
2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks.
Comparatore attivo: Control group
weekly meal planning materials and recipes only; no food will be provided.
weekly recipes and meal-planning materials only; no food will be provided.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Evaluation of feasibility of consuming medically tailored meals through study participation
Lasso di tempo: From enrollment to the end of study, assessed at year 3 follow-up

Feasibility will be assessed by the following metrics:

• percentage of eligible patients who enroll

From enrollment to the end of study, assessed at year 3 follow-up
Evaluation of feasibility of consuming medically tailored meals through retention
Lasso di tempo: From enrollment to the end of study, assessed at year 3 follow-up

Feasibility will be assessed by the following metrics:

• percentage of enrolled participants who complete study visits and outcome assessments

From enrollment to the end of study, assessed at year 3 follow-up
Evaluation of feasibility of consuming medically tailored meals through compliance
Lasso di tempo: From enrollment to the final visit at 8 weeks

Feasibility will be assessed by the following metrics:

• proportion of participants who adhere to assigned interventions, defined as consumption of provided meals and/or produce (for intervention arms), completion of at least two dietary assessments, and provision of blood, tumor tissue, and fecal samples at baseline and end of intervention

From enrollment to the final visit at 8 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
MTM Impact on Diet
Lasso di tempo: From enrollment to the end of study, assessed at year 3 follow-up
The extent to which the MTM-based intervention improves dietary intake and food insecurity across study arms
From enrollment to the end of study, assessed at year 3 follow-up
MTM Impact on Patient Outcomes
Lasso di tempo: From enrollment to the end of study, assessed at year 3 follow-up
The extent to which the MTM-based intervention improves quality of life and patient-reported outcomes across study arms
From enrollment to the end of study, assessed at year 3 follow-up
Relative Composition of Gut Microbiome Features
Lasso di tempo: From enrollment to the final visit at 8 weeks
Comparing change in gut microbiome features (species - to strain level specificity; metabolic pathways; enzymes) using deep meta'omic profiling in pre- and post- treatment samples.
From enrollment to the final visit at 8 weeks
Relative Composition of Gut Metabolites
Lasso di tempo: From enrollment to the final visit at 8 weeks
Comparing change in gut metabolites using deep meta'omic profiling in pre- and post- treatment samples.
From enrollment to the final visit at 8 weeks
Change in Stool Metabolomics
Lasso di tempo: From enrollment to the final visit at 8 weeks
Comparing change in stool metabolomics, using non-targeted global metabolomics analysis on stool samples to examine intensity changes in the stool metabolite profile.
From enrollment to the final visit at 8 weeks
Change in Plasma Metabolomics
Lasso di tempo: From enrollment to the final visit at 8 weeks
Comparing change in plasma metabolomics, using non-targeted global metabolomics analysis on blood samples to examine intensity changes in the blood metabolite profile.
From enrollment to the final visit at 8 weeks
Longitudinal Biomarker Changes
Lasso di tempo: From enrollment to the end of study, assessed at year 3 follow-up
Changes in clinical biomarkers using EHR data.
From enrollment to the end of study, assessed at year 3 follow-up
Longitudinal Disease Progression Changes
Lasso di tempo: From enrollment to the end of study, assessed at year 3 follow-up
Changes in disease progression outcomes using EHR data.
From enrollment to the end of study, assessed at year 3 follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Mengxi Du, RD, PhD, MPH, Massachusetts General Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 agosto 2026

Completamento primario (Stimato)

10 agosto 2028

Completamento dello studio (Stimato)

10 ottobre 2028

Date di iscrizione allo studio

Primo inviato

22 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

14 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Mengxi Du, RD, PhD, MPH. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Periodo di condivisione IPD

Data can be shared no earlier than 1 year following the date of publication

Criteri di accesso alla condivisione IPD

Contact the MGB Innovation at PHSINNOVATIONSUPPORT@partners.org

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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