Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644560
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
A Nutrition Exercise Prehabilitation Intervention on Inflammatory Biomarkers in AI Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Nutrition and Exercise Prehabilitation Intervention on Inflammatory Biomarkers in American Indian Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 IndianAlaskan Natives AIAN have the worst cancer survival rates of any US racial group and are 16 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None