University of Arizona
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.
Cancer
Obesity
Prehabilitation Intervention
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 30 participants |
| Masking : | NONE |
| Primary Purpose : | PREVENTION |
| Official Title : | A Nutrition and Exercise Prehabilitation Intervention on Inflammatory Biomarkers in American Indian Cancer Patients |
| Actual Study Start Date : | 2024-12-01 |
| Estimated Primary Completion Date : | 2027-03-31 |
| Estimated Study Completion Date : | 2028-06-30 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 80 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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Not yet recruiting
University of Arizona Cancer Center
Tucson, arizona, United States, 85724