NCT06644560 A Nutrition & Exercise Prehabilitation Intervention on Inflammatory Biomarkers in AI Cancer Patients
| NCT ID | NCT06644560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Arizona |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-11-13 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-11-13 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Jennifer Erdrich, MD
PRINCIPAL INVESTIGATOR
University of Arizona
Frequently Asked Questions
Who can join the NCT06644560 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06644560 currently recruiting?
Yes, NCT06644560 is actively recruiting participants. Contact the research team at jerdrich@surgery.arizona.edu for enrollment information.
Where is the NCT06644560 trial being conducted?
This trial is being conducted at Tucson, United States.
Who is sponsoring the NCT06644560 clinical trial?
NCT06644560 is sponsored by University of Arizona. The principal investigator is Jennifer Erdrich, MD at University of Arizona. The trial plans to enroll 30 participants.
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