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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT06644560
Status
Recruiting
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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Prehabilitation 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

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.

Key Dates

Start date
Nov 13, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Prehabilitation Intervention
    This is a single-arm, pre-post, window of opportunity trial. The tailored prehab program will be implemented for AI cancer patients preparing for cancer treatment for a 3-week duration prior to their first treatment. The prehab intervention is designed to modify inflammatory biomarkers in paired pre/post-intervention blood and tissue samples. 30 individuals who are 18-80 years old with a diagnosis of cancer, scheduled at least 3 weeks out from cancer treatment who are receiving care at SCAHC will be recruited over the duration of the study. Blood samples will be collected before and after the prehab, and inflammatory biomarkers will be measured in the paired pre/post blood sample. Unstained slides from the diagnostic biopsy and resected tumor specimen will be requested, and inflammatory biomarkers will be measured in the paired pre/post tissue sample.

Primary Outcome Measure

Patient enrollment and retention: proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurements [ Time Frame: Baseline and post-intervention (an average of 5 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85724
Jennifer Erdrich, MD
[email protected]
(520) 626-2635
Melissa Carton
[email protected]
Jennifer Erdrich, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Arizona Cancer Center· Tucson, AZ

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