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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Ready-to-eat or ready-to-heat dishes, such as packaged frozen meals, prepared entrées, quick dishes, or microwaveable packaged foods;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • MTM: Medically tailored meals
  • MTM plus Fresh Produce
  • Control group

Treatment groups

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

National Cancer Institute (NCI)

Collaborator