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

Overview

The purpose of this study is to assess the feasibility of a prehab intervention among American Indian (AI) patients diagnosed with 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 cancer scheduled for treatment. 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 treatment for a 3-week duration before their first treatment. 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 cancer, scheduled at least 3 weeks out from cancer treatment 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.

Interventions

• Behavioral Prehabilitation Intervention
  The intervention involves a 3-week prehabilitation program during the participant's pre-treatment window before cancer treatment. 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,

Primary outcome measures

• Patient enrollment and retention: proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurements [Time frame: Baseline and post-intervention (an average of 5 weeks)]
• Adherence to study protocol: compliance with intervention foods (walnuts) [Time frame: 3 weeks during participant's preoperative window]
• Adherence to study protocol: compliance with exercise recommendations [Time frame: 3 weeks during participant's preoperative window]
• Assessing patient acceptability via exit interviews to solicit patient experience and feedback [Time frame: 3 weeks during participant's post-intervention assessment]
• Comparison of pre/post-intervention 6 Minute Walk Test Scores to assess lifestyle behavioral change [Time frame: Baseline and post-intervention assessment (an average of 3 weeks)]
• Comparison of pre/post-intervention sit-to-stand test scores to assess lifestyle behavioral change [Time frame: Baseline and post-intervention assessment (an average of 3 weeks)]
• Comparison of pre/post-intervention patient responses to the Dietary Screener Questionnaire [Time frame: Baseline and post-intervention assessment (an average of 3 weeks)]
• Comparison of pre/post-intervention patient responses to the Arizona Activity Questionnaire [Time frame: Baseline and post-intervention assessment (an average of 3 weeks)]
• Assessing biosample collection rates: percentage of patients completing blood and tissue sample collection [Time frame: Baseline and post-intervention assessment (an average of 3 weeks)]

Secondary outcome measures (5)

• Assess stability of anthropometric measures: blood pressure [Time frame: Baseline and post-intervention assessment (an average of 3 weeks)]
• Assess stability of anthropometric measures: weight [Time frame: Baseline and post-intervention assessment (an average of 3 weeks)]
• Assess stability of anthropometric measures: waist circumference [Time frame: Baseline and post-intervention assessment (an average of 3 weeks)]
• Assess changes between pre and post intervention levels of serum biomarkers. [Time frame: Baseline and post-intervention assessment (an average of 3 weeks)]
• For patients undergoing procedural treatment that generates tissue specimens, assess changes between pre and post intervention levels of tissue biomarkers. [Time frame: Baseline and post-intervention assessment (an average of 3 weeks)]

Eligibility criteria

Inclusion criteria

• Age 18-80 years
• Diagnosed with cancer of any kind
• Scheduled at least 3 weeks out from first treatment
• Receiving care at San Carlos Apache Healthcare Corporation (SCAHC)
• Able to eat walnuts
• Able to do moderate-intensity exercise

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• University of Arizona Cancer Center — Tucson

Identifiers

NCT: NCT06644560 · STUDY00004848 · K08CA276137

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗