A Nutrition & Exercise Prehabilitation Intervention on Inflammatory Biomarkers in AI Cancer Patients
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Arizona
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Prehabilitation Intervention
BehavioralThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Prehabilitation InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient enrollment and retention: proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurements
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via patient enrollment and retention. Patient retention will be estimated as the proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurements, with an exact 95% binomial confidence interval.
Time frame
Baseline and post-intervention (an average of 5 weeks)2
Adherence to study protocol: compliance with intervention foods (walnuts)
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via compliance with intervention foods (walnuts). Compliance with intervention foods (walnuts) will be estimated as the number of daily packets eaten/number distributed, with an exact 95% binomial confidence interval.
Time frame
3 weeks during participant's preoperative window3
Adherence to study protocol: compliance with exercise recommendations
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via compliance with exercise recommendations. Compliance with exercise recommendations will be estimated as the increase in daily steps (as measured by pedometers) post- versus pre-intervention using a 95% confidence interval.
Time frame
3 weeks during participant's preoperative window4
Assessing patient acceptability via exit interviews to solicit patient experience and feedback
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via exit interviews. The exit interviews will provide qualitative data for assessment. The interview transcriptions will be coded and themed. Themes will be vetted with SCAHC staff to ensure shared understanding of concepts and accurate representation of community perspective.
Time frame
3 weeks during participant's post-intervention assessmentSecondary outcomes
1
Assess stability of anthropometric measures: blood pressure
Blood pressure is measured in units of millimeters of mercury (mmHg). Pre/post intervention changes will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
Time frame
Baseline and post-intervention assessment (an average of 3 weeks)2
Assess stability of anthropometric measures: weight
Weight will be measured in kilograms. Pre/post intervention changes will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
Time frame
Baseline and post-intervention assessment (an average of 3 weeks)3
Assess stability of anthropometric measures: waist circumference
Waist circumference will be measured in centimeters. Pre/post intervention changes will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
Time frame
Baseline and post-intervention assessment (an average of 3 weeks)4
Assess changes between pre and post intervention levels of serum biomarkers.
Serum biomarkers \[including CRP, IL-6, IL-10, TNFa, IGF-1, VEGF, complete blood count (CBC) with differential, comprehensive metabolic panel (CMP), and prealbumin\] will be quantified with ELISA. Changes in serum biomarker levels will be estimated using 95% confidence intervals.
Time frame
Baseline and post-intervention assessment (an average of 3 weeks)Other outcomes
1
Assess differential expression of inflammatory genes in the tumor microenvironment
For patients who agree to the optional exploratory aim, the existing diagnostic biopsy tissue and surgical specimen tissue can be additionally analyzed for gene expression data. Genes related to inflammation would be measured and no other genes would be studied.
Time frame
Baseline and post-intervention (an average of 3 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arizona
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov