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

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

NCT ID: NCT06644560

Condition: Cancer
Obesity

Conditions: Official terms:
Obesity

Conditions: Keywords:
Obesity-related cancer
Nutrition and Exercise Prehabilitation Intervention
Inflammatory biomarkers

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Prehabilitation Intervention
Description: The intervention involves a 3-week prehabilitation program during the participant's preoperative window before cancer surgery. 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.
Arm group label: Prehabilitation Intervention

Other name: Prehab Intervention

Summary: The purpose of this study is to assess the feasibility of a prehab intervention among American Indian (AI) patients diagnosed with obesity-related 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 obesity-related solid tumor cancer scheduled for surgery. 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.

Detailed description: American Indian/Alaskan Natives (AI/AN) have the worst cancer survival rates of any U.S. racial group and are 1.6 times more likely to be obese than the general population. Inflammation is a reversible mechanism through which obesity increases the risk of cancer incidence and progression. Prehabilitation (prehab) is a strategy utilizing lifestyle modifications in physical activity, nutrition, smoking cessation, and/or psychological support to optimize patients' functional capacity and improve postoperative outcomes. The proposed project is to (1) implement the prehab translational clinical trial for AI patients with obesity-related solid tumor cancer preparing for surgery and (2) measure inflammatory biomarkers pre and post-intervention to assess responsiveness. The intervention will be piloted in a sample of 30 patients with obesity-related solid tumor cancer who are enrolled tribal members, age 18-80 years, undergoing surgical resection of the tumor with at least 3 weeks until operation. Patients will eat walnuts, and exercise by walking 30 minutes daily and attending fitness sessions twice weekly during the 3 week study period. Patients will complete pre and post surveys, 6 minute walk test, 30 second sit-to-stand test, biosample collection and anthropometric measurements. These assessments will help us understand if the walnuts and exercise can mitigate inflammation in the tumor. Prior published programs have featured similar sized groups for feasibility testing. Patient reported acceptability, lifestyle behavior change, and biosample collection rates will be evaluated to assess feasibility and gain effect size estimates for a future R01 trial.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age 18-80 years - Clinical diagnosis of obesity-related solid tumor cancer: obesity-related solid tumor cancers include thyroid, breast, liver, gallbladder, gastric, pancreatic, colorectal, ovarian, uterine, kidney, esophageal cancers. - Preoperative status with plan to undergo an operation to remove the tumor - Scheduled at least 3 weeks out from the operation - Enrolled member of the San Carlos Apache nation - Must be having cancer surgery at San Carlos Apache Healthcare Corporation or Banner University Medical Center-Tucson Exclusion Criteria: - Current or planned receipt of chemotherapy during the preoperative study period - 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Arizona Cancer Center

Address:
City: Tucson
Zip: 85724
Country: United States

Contact:
Last name: Jennifer Erdrich, MD

Phone: 520-626-2635
Email: jerdrich@surgery.arizona.edu

Contact backup:
Last name: Melissa Carton
Email: mcarton@arizona.edu

Investigator:
Last name: Jennifer Erdrich, MD
Email: Principal Investigator

Start date: December 1, 2024

Completion date: June 30, 2028

Lead sponsor:
Agency: University of Arizona
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Arizona

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06644560