Nutrition & Exercise Prehabilitation for Obesity-Related Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByJennifer Erdrich, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Arizona

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for American Indian patients who have obesity-related cancers and are scheduled for surgery. It's designed to test a prehabilitation program that includes nutrition and exercise, aiming to improve their health before treatment.

Inclusion Criteria

My cancer is related to obesity and affects organs like the thyroid, breast, or liver.

I am scheduled for surgery to remove my tumor.

I am between 18 and 80 years old.

I am having my cancer surgery at San Carlos Apache Healthcare or Banner University Medical Center-Tucson.

Exclusion Criteria

I am currently receiving or will receive chemotherapy before surgery.

I do not have heart disease that stops me from doing moderate exercise.

I have a digestive condition that limits my diet changes.

Participant Groups

The study tests a 'prehab' intervention combining diet and physical activity to see if it can change certain blood and tissue markers linked with inflammation in these cancer patients. The effects will be measured before and after the intervention.

1Treatment groups

Experimental Treatment

Group I: Prehabilitation InterventionExperimental Treatment1 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 surgery for a 3-week duration in the preoperative window of opportunity. 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 obesity-related solid tumor cancer, scheduled at least 3 weeks out from cancer surgery who are enrolled tribal members 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.