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

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Arizona

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

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Arizona

Lead sponsor

National Cancer Institute (NCI)

Collaborator