No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
30 (estimated)
Sponsor
University of Arizona · Other
Who this trial is looking for
This trial is looking for American Indian adults diagnosed with cancer who are at least 3 weeks away from their first treatment. Participants will take part in a nutrition and exercise program and provide blood and tissue samples to help measure changes in inflammation levels.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 80 years old.
I have been diagnosed with cancer.
I am scheduled for treatment in at least 3 weeks.
I receive care at San Carlos Apache Healthcare Corporation.
I can eat walnuts.
I can do moderate-intensity exercise.
You may not be able to join if
I have a digestive tract disease that restricts my diet.
I am allergic to the foods in the nutrition program.
I have uncontrolled cardiac disease.
I have other health issues that prevent me from exercising.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-mic…
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.
Trial Locations
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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…
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
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