Clinical trial NCT06644560: A Nutrition & Exercise Prehabilitation Intervention on Inflammatory Biomarkers in AI Cancer Patients
Official title: A Nutrition and Exercise Prehabilitation Intervention on Inflammatory Biomarkers in American Indian Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Obesity
Keywords: Obesity-related cancer
Nutrition and Exercise Prehabilitation Intervention
Inflammatory biomarkers
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: The research entails a single-arm, pre-post, window-of-opportunity prehab intervention trial. The tailored prehab program will be implemented for cancer patients receiving care at San Carlos Apache Healthcare Corporation (SCAHC) who are 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.

For the pilot intervention, 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 receive care at SCAHC will be recruited over the duration of the study. Participants meeting criteria will be screened for eligibility. Those meeting eligibility criteria who are interested will be consented and enrolled. They will undergo baseline measurements that include medical/ family/cancer history and demographics, baseline anthropometric measures (blood pressure, weight, height, and waist circumference), completion of diet/exercise and health behavior questionnaires, 6-minute walk test, sit-to- stand test and blood samples which will be run for inﬂammatory biomarkers. The consent will include permission to obtain the diagnostic biopsy tissue for the purposes of this research study to measure tissue biomarkers.

After baseline evaluation, patients will receive diet and exercise counseling prior to commencing the prehab program. They will receive general nutritional guidance on healthy eating, walking, and instructed on the methods of self-monitoring their activity levels (pedometer, daily log, checklists). They will participate in twice weekly 60-minute training sessions supervised by certiﬁed fitness trainers and perform 30 minutes of walking daily on their own. They will consume 60g of walnuts (1/2cup) which can be consumed raw or incorporated into meals and recipes of their choosing. Participants will return to the clinic after 3 weeks of the prehab program to repeat all baseline metrics and participate in an exit interview. Residual tissue from the surgical specimen after clinical assessments are completed will be used to measure post-intervention biomarker expression.

Paired pre/post-intervention blood and tissue samples will be stored and analyzed for biomarker expression at the University of Arizona Shared Resources. Analysis of the qualitative data from the exit interviews and the biospecimens will be conducted at the University of Arizona.

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
* Receiving care at San Carlos Apache Healthcare Corporation (SCAHC)
* 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

Primary outcomes:
measure: Patient enrollment and retention: proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurements
timeFrame: Baseline and post-intervention (an average of 5 weeks)
measure: Adherence to study protocol: compliance with intervention foods (walnuts)
timeFrame: 3 weeks during participant's preoperative window
measure: Adherence to study protocol: compliance with exercise recommendations
timeFrame: 3 weeks during participant's preoperative window
measure: Assessing patient acceptability via exit interviews to solicit patient experience and feedback
timeFrame: 3 weeks during participant's post-intervention assessment
measure: Comparison of pre/post-intervention 6 Minute Walk Test Scores to assess lifestyle behavioral change
timeFrame: Baseline and post-intervention assessment (an average of 3 weeks)
measure: Comparison of pre/post-intervention sit-to-stand test scores to assess lifestyle behavioral change
timeFrame: Baseline and post-intervention assessment (an average of 3 weeks)
measure: Comparison of pre/post-intervention patient responses to the Dietary Screener Questionnaire
timeFrame: Baseline and post-intervention assessment (an average of 3 weeks)
measure: Comparison of pre/post-intervention patient responses to the Arizona Activity Questionnaire
timeFrame: Baseline and post-intervention assessment (an average of 3 weeks)
measure: Assessing biosample collection rates: percentage of patients completing blood and tissue sample collection
timeFrame: Baseline and post-intervention assessment (an average of 3 weeks)
Secondary outcomes:
measure: Assess stability of anthropometric measures: blood pressure
timeFrame: Baseline and post-intervention assessment (an average of 3 weeks)
measure: Assess stability of anthropometric measures: weight
timeFrame: Baseline and post-intervention assessment (an average of 3 weeks)
measure: Assess stability of anthropometric measures: waist circumference
timeFrame: Baseline and post-intervention assessment (an average of 3 weeks)
measure: Assess changes between pre and post intervention levels of serum biomarkers.
timeFrame: Baseline and post-intervention assessment (an average of 3 weeks)
measure: Assess changes between pre and post intervention levels of tissue biomarkers.
timeFrame: Baseline and post-intervention assessment (an average of 3 weeks)
Other outcomes:
measure: Assess differential expression of inflammatory genes in the tumor microenvironment
timeFrame: Baseline and post-intervention (an average of 3 weeks)
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Jennifer Erdrich, MD
role: PRINCIPAL_INVESTIGATOR
References: