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

NCT06644560 | Recruiting

• 2 other identifiers: STUDY00004848K08CA276137
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Nutrition and Exercise Prehabilitation Intervention; Inflammatory biomarkers; Cancer

Outcome Measures

Primary Outcomes (9)

• 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.

  Baseline and post-intervention (an average of 5 weeks)

• 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.

  3 weeks during participant's preoperative window

• 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.

  3 weeks during participant's preoperative window

• 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.

  3 weeks during participant's post-intervention assessment

• Comparison of pre/post-intervention 6 Minute Walk Test Scores to assess lifestyle behavioral change

  Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via the 6 Minute Walk Test scores. The score of the 6MWT is the distance a patient walks in 6 minutes. Pre/post intervention performance changes on the 6MWT will be estimated using 95% confidence intervals, with transformation as needed to induce normality.

  Baseline and post-intervention assessment (an average of 3 weeks)

• Comparison of pre/post-intervention sit-to-stand test scores to assess lifestyle behavioral change

  Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via the sit-to-stand test scores. The sit-to-stand test score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand). Pre/post intervention performance changes on the sit-to-stand test will be estimated using 95% confidence intervals, with transformation as needed to induce normality.

  Baseline and post-intervention assessment (an average of 3 weeks)

• Comparison of pre/post-intervention patient responses to the Dietary Screener Questionnaire

  Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via comparing pre/post- intervention responses to the Dietary Screener Questionnaire. The Dietary Screener Questionnaire has 30 questions. There is a scoring algorithm that converts the responses to estimates of dietary intake of fruits and vegetables, dairy, added sugar, whole grain, fiber, and calcium. Changes between pre and post intervention will be estimated using 95% confidence intervals, with transformation as needed to induce normality.

  Baseline and post-intervention assessment (an average of 3 weeks)

• Comparison of pre/post-intervention patient responses to the Arizona Activity Questionnaire

  Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via comparing Arizona Activity Questionnaire. The Arizona Activity Questionnaire has 14 sections with 77 line items. There is a formula that converts the responses to estimates of total energy expenditure and physical activity energy expenditure. Changes between pre and post intervention will be estimated using 95% confidence intervals, with transformation as needed to induce normality.

  Baseline and post-intervention assessment (an average of 3 weeks)

• Assessing biosample collection rates: percentage of patients completing blood and tissue sample collection

  Primary endpoint: determining feasibility of the prehabilitation intervention by assessing percentage of patients who complete blood and tissue sample collections. Biosample collection rates (plasma and tissue) will be estimated as the proportion of patients who provide biospecimens at the pre- and post-intervention visits, with exact 95% binomial confidence intervals.

  Baseline and post-intervention assessment (an average of 3 weeks)

Secondary Outcomes (5)

• Assess stability of anthropometric measures: blood pressure

  Baseline and post-intervention assessment (an average of 3 weeks)

• Assess stability of anthropometric measures: weight

  Baseline and post-intervention assessment (an average of 3 weeks)

• Assess stability of anthropometric measures: waist circumference

  Baseline and post-intervention assessment (an average of 3 weeks)

• Assess changes between pre and post intervention levels of serum biomarkers.

  Baseline and post-intervention assessment (an average of 3 weeks)

• For patients undergoing procedural treatment that generates tissue specimens, assess changes between pre and post intervention levels of tissue biomarkers.

  Baseline and post-intervention assessment (an average of 3 weeks)

Other Outcomes (1)

• Assess differential expression of inflammatory genes in the tumor microenvironment

  Baseline and post-intervention (an average of 3 weeks)

Study Arms (1)

Prehabilitation Intervention

EXPERIMENTAL

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.

Behavioral: Prehabilitation Intervention

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.

Also known as: Prehab Intervention

Prehabilitation Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jennifer Erdrich, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Erdrich, MD

CONTACT

(520) 626-2635; jerdrich@surgery.arizona.edu

Melissa Carton

CONTACT

mcarton@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 16, 2024
• Study Start: November 13, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)