A Nutrition and Exercise Prehabilitation Intervention on Inflammatory Biomarkers in American Indian Cancer Patients
University of Arizona
Summary
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.
Description
The research entails a single-arm, pre-post, window-of-opportunity prehab intervention trial. The tailored prehab program will be implemented for cancer patients receiving care at San Carlos Apache Healthcare Corporation (SCAHC) who are preparing for cancer treatment for a 3-week duration before their first treatment. The prehab intervention is designed to modify inflammatory biomarkers in paired pre/post-intervention blood and tissue samples. For the pilot intervention, 30 individuals who are 18-80 years old with a diagnosis of cancer, scheduled at least 3 weeks out from cancer treatment who…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Interventions
- BehavioralPrehabilitation Intervention
The intervention involves a 3-week prehabilitation program during the participant's pre-treatment window before cancer treatment. During the intervention, patients will be asked to consume 60 grams of walnuts daily, participate in two 60-minute individualized supervised physical activity training sessions per week, meet with a nutritionist for a 30-60 minute session, and conduct 30 minutes of independent walking per day. The participants will be given pre-portioned walnuts for daily consumption, a pedometer, and educational materials. The participants will track their completion of tasks with a daily log and the study coordinator will also track their attendance at scheduled nutrition and fitness sessions. In addition, the study coordinator will check-in with participants twice weekly and send text reminders about their required activities.
Location
- University of Arizona Cancer CenterTucson, Arizona