Nutrition and exercise prehabilitation to reduce inflammation in American Indian adults with cancer
A Nutrition and Exercise Prehabilitation Intervention on Inflammatory Biomarkers in American Indian Cancer Patients
This program will test whether a 3-week nutrition and exercise prehabilitation plan can lower inflammation markers in American Indian adults with cancer who are waiting to start treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT06644560 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, pre–post, window-of-opportunity pilot where 30 adults receiving care through San Carlos Apache Healthcare Corporation will complete a tailored 3-week nutrition and exercise prehabilitation program before their first cancer treatment. Baseline and post-intervention paired blood and diagnostic biopsy tissue samples will be collected to measure host and tumor-microenvironment inflammatory biomarkers (for example CRP, IL-6, IL-10, TNFα, VEGF, CBC/CMP, Ki67, NF-κB, NOS2). Participants will receive diet counseling (including walnut-containing nutrition guidance) and a moderate-intensity exercise program with functional tests (6-minute walk, sit-to-stand) and anthropometric measures. The main aims are to test feasibility, patient acceptability, and preliminary changes in inflammatory biomarkers following the intervention.
Who should consider this trial
Good fit: Adults aged 18–80 with any cancer diagnosis who receive care at San Carlos Apache Healthcare Corporation, are scheduled at least three weeks before first treatment, can eat walnuts, and can perform moderate-intensity exercise are ideal candidates.
Not a fit: People with digestive diseases that prevent diet changes, an allergy to the intervention foods (including walnuts), or uncontrolled cardiac disease or other contraindications to moderate exercise may not benefit or may be excluded.
Why it matters
Potential benefit: If successful, the program could reduce systemic and tumor-associated inflammation, help patients enter treatment in better physical condition, and inform culturally tailored supportive care for American Indian patients.
How similar studies have performed: Prehabilitation programs in other cancer populations have shown improved fitness and some perioperative outcomes, but using a culturally informed prehab to alter inflammatory and tumor-microenvironment biomarkers in American Indian patients is largely novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tucson, Arizona
- University of Arizona Cancer Center — Tucson, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Erdrich, MD — University of Arizona
- Study coordinator: Jennifer Erdrich, MD
- Email: jerdrich@surgery.arizona.edu
- Phone: (520) 626-2635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.