A Nutrition & Exercise Prehabilitation Intervention on Inflammatory Biomarkers in AI Cancer Patients

Recruiting now · Not applicable

Conditions studied: Cancer

In brief

The purpose of this study is to assess the feasibility of a prehab intervention among American Indian (AI) patients diagnosed with cancer and measure inflammatory biomarkers to evaluate the preliminary impact of the trial intervention. The central hypothesis is that this community-informed prehab intervention will demonstrate feasibility, patient acceptability, and modulation of host and tumor-microenvironment inflammatory biomarkers. Aim 1: Implement the prehab translational clinical trial for AI patients with cancer scheduled for treatment. Aim 2 Measure host and tumor-microenvironment (TME) biomarkers using paired serum and tissue samples to compare baseline and post-intervention levels of expression. Serum markers include CRP, IL-6, IL-10, TNFa, IGF-1, VEGF, complete blood count (CBC) with differential, comprehensive metabolic panel (CMP), and prealbumin. Tissue markers include Ki67, insulin receptor, TNFa, NFKB, NOS2, and cleaved caspase 3. Aim 3: (optional exploratory aim): Assess differential expression of inflammatory genes in the TME using tumor tissue samples to compare baseline and post-intervention levels of expression. This will be done with a panel that analyzes inflammatory genes only.

Key facts

Study ID

NCT06644560

Run by

University of Arizona

People needed

30

Starts

2025-11-13

Expected to finish

2028-06-30

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-80 years
• Diagnosed with cancer of any kind
• Scheduled at least 3 weeks out from first treatment
• Receiving care at San Carlos Apache Healthcare Corporation (SCAHC)
• Able to eat walnuts
• Able to do moderate-intensity exercise

You may not qualify if…

• Digestive tract disease that would restrict diet modifications
• Allergy to the foods intended for the nutrition intervention
• Uncontrolled cardiac disease or other contraindications to moderate-intensity exercise

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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