RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the feasibility of a prehab intervention among American Indian (AI) patients diagnosed with obesity-related 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 obesity-related solid tumor cancer scheduled for surgery. 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.

Official Title

A Nutrition and Exercise Prehabilitation Intervention on Inflammatory Biomarkers in American Indian Cancer Patients

Quick Facts

Study Start:2025-09
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06644560

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-80 years
  2. * Clinical diagnosis of obesity-related solid tumor cancer: obesity-related solid tumor cancers include thyroid, breast, liver, gallbladder, gastric, pancreatic, colorectal, ovarian, uterine, kidney, esophageal cancers.
  3. * Preoperative status with plan to undergo an operation to remove the tumor
  4. * Scheduled at least 3 weeks out from the operation
  5. * Receiving care at San Carlos Apache Healthcare Corporation (SCAHC)
  6. * Must be having cancer surgery at San Carlos Apache Healthcare Corporation or Banner University Medical Center-Tucson
  1. * Current or planned receipt of chemotherapy during the preoperative study period
  2. * Digestive tract disease that would restrict diet modifications
  3. * Allergy to the foods intended for the nutrition intervention
  4. * Uncontrolled cardiac disease or other contraindications to moderate-intensity exercise

Contacts and Locations

Study Contact

Jennifer Erdrich, MD
CONTACT
(520) 626-2635
jerdrich@surgery.arizona.edu
Melissa Carton
CONTACT
mcarton@arizona.edu

Principal Investigator

Jennifer Erdrich, MD
PRINCIPAL_INVESTIGATOR
University of Arizona

Study Locations (Sites)

University of Arizona Cancer Center
Tucson, Arizona, 85724
United States

Collaborators and Investigators

Sponsor: University of Arizona

  • Jennifer Erdrich, MD, PRINCIPAL_INVESTIGATOR, University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2025-09
Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

  • Obesity-related cancer
  • Nutrition and Exercise Prehabilitation Intervention
  • Inflammatory biomarkers

Additional Relevant MeSH Terms

  • Cancer
  • Obesity