Recruiting

Prehab Intervention

Sponsor:

University of Arizona

Code:

NCT06644560

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Prehabilitation Intervention

Study Details

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

Study ID

NCT06644560

Start date

Nov 13, 2025

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Prehabilitation Intervention

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.

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) ]
  • Adherence to study protocol: compliance with intervention foods (walnuts) [ Time Frame: 3 weeks during participant's preoperative window ]
  • Adherence to study protocol: compliance with exercise recommendations [ Time Frame: 3 weeks during participant's preoperative window ]
  • Assessing patient acceptability via exit interviews to solicit patient experience and feedback [ Time Frame: 3 weeks during participant's post-intervention assessment ]
  • Comparison of pre/post-intervention 6 Minute Walk Test Scores to assess lifestyle behavioral change [ Time Frame: 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 [ Time Frame: Baseline and post-intervention assessment (an average of 3 weeks) ]
  • Comparison of pre/post-intervention patient responses to the Dietary Screener Questionnaire [ Time Frame: Baseline and post-intervention assessment (an average of 3 weeks) ]
  • Comparison of pre/post-intervention patient responses to the Arizona Activity Questionnaire [ Time Frame: Baseline and post-intervention assessment (an average of 3 weeks) ]
  • Assessing biosample collection rates: percentage of patients completing blood and tissue sample collection [ Time Frame: Baseline and post-intervention assessment (an average of 3 weeks) ]

Central Contacts and Locations

Central contacts

Jennifer Erdrich, MD

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

Melissa Carton

mcarton@arizona.edu

Locations

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Jennifer Erdrich, MD

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

Melissa Carton

mcarton@arizona.edu

Principal Investigator:

Jennifer Erdrich, MD

More Information

Sponsor

University of Arizona

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • Nutrition and Exercise Prehabilitation Intervention
  • Inflammatory biomarkers
  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-04-30.