About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Prehabilitation Intervention
Treatment groups
Sponsors and collaborators
University of Arizona
Lead sponsor
National Cancer Institute (NCI)
Collaborator