What this study is
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.
What's being tested
- Prehabilitation Intervention
Intervention · BEHAVIORAL
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.
Study details
- Official title
- A Nutrition and Exercise Prehabilitation Intervention on Inflammatory Biomarkers in American Indian Cancer Patients
- Sponsor
- University of Arizona
- Conditions
- Cancer
- Enrolling
- 30 people
- Starts
- 2025-11-13
- Est. completion
- 2028-06-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Arizona Cancer Center
Tucson, Arizona, United States
- Jennifer Erdrich, MD · Contact(520) 626-2635jerdrich@surgery.arizona.edu
- Melissa Carton · Contactmcarton@arizona.edu
- Jennifer Erdrich, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Arizona
Study ID STUDY00004848
Principal investigator
Jennifer Erdrich, MD
University of Arizona
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.