A Nutrition & Exercise Prehabilitation Intervention on Inflammatory Biomarkers in AI Cancer Patients
NCT06644560
Summary
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.
Eligibility
Inclusion Criteria: * Age 18-80 years * 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. * Preoperative status with plan to undergo an operation to remove the tumor * Scheduled at least 3 weeks out from the operation * Receiving care at San Carlos Apache Healthcare Corporation (SCAHC) * Must be having cancer surgery at San Carlos Apache Healthcare Corporation or Banner University Medical Center-Tucson Exclusion Criteria: * Current or planned receipt of chemotherapy during the preoperative study period * 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
Conditions2
Locations1 site
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NCT06644560