Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06644560

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

Led by University of Arizona · Updated on 2026-04-30

30

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

Sponsors

U

University of Arizona

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Arizona Cancer Center

Tucson, Arizona, United States, 85724

Actively Recruiting

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Research Team

J

Jennifer Erdrich, MD

CONTACT

M

Melissa Carton

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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