CancerNCT06644560
A Nutrition & Exercise Prehabilitation Intervention on Inflammatory Biomarkers in AI Cancer Patients
A study testing Prehabilitation Intervention in people with Cancer, run by University of Arizona at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- Prehabilitation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melissa Carton contact
United States1 site, 1 recruiting
- Recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85724
Jennifer Erdrich, MD, (520) 626-2635, jerdrich@surgery.arizona.edu
Melissa Carton, mcarton@arizona.edu
About this study
Official title: A Nutrition and Exercise Prehabilitation Intervention on Inflammatory Biomarkers in American Indian Cancer Patients
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.
Read more
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Prehabilitation Intervention
- Keywords
- Nutrition and Exercise Prehabilitation Intervention, Inflammatory biomarkers, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation InterventionBehavioural
Also called Prehab 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, a pedometer, and educational materials. The participants will track their completion of tasks with a daily log and the study coordinator will also track their attendance at scheduled nutrition and fitness sessions. In addition, the study coordinator will check-in with participants twice weekly and send text reminders about their required activities.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation Intervention | Experimental | 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 treatment for a 3-week duration prior to their first treatment. 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 cancer, scheduled at least 3 weeks out from cancer treatment who are receiving care at SCAHC 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. Receives: Behavioral: Prehabilitation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient enrollment and retention: proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurements
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via patient enrollment and retention. Patient retention will be estimated as the proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurements, with an exact 95% binomial confidence interval.
Measured: Baseline and post-intervention (an average of 5 weeks)
Adherence to study protocol: compliance with intervention foods (walnuts)
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via compliance with intervention foods (walnuts). Compliance with intervention foods (walnuts) will be estimated as the number of daily packets eaten/number distributed, with an exact 95% binomial confidence interval.
Measured: 3 weeks during participant's preoperative window
Adherence to study protocol: compliance with exercise recommendations
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via compliance with exercise recommendations. Compliance with exercise recommendations will be estimated as the increase in daily steps (as measured by pedometers) post- versus pre-intervention using a 95% confidence interval.
Measured: 3 weeks during participant's preoperative window
Assessing patient acceptability via exit interviews to solicit patient experience and feedback
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via exit interviews. The exit interviews will provide qualitative data for assessment. The interview transcriptions will be coded and themed. Themes will be vetted with SCAHC staff to ensure shared understanding of concepts and accurate representation of community perspective.
Measured: 3 weeks during participant's post-intervention assessment
Comparison of pre/post-intervention 6 Minute Walk Test Scores to assess lifestyle behavioral change
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via the 6 Minute Walk Test scores. The score of the 6MWT is the distance a patient walks in 6 minutes. Pre/post intervention performance changes on the 6MWT will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
Measured: 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
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via the sit-to-stand test scores. The sit-to-stand test score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand). Pre/post intervention performance changes on the sit-to-stand test will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
Measured: Baseline and post-intervention assessment (an average of 3 weeks)
Comparison of pre/post-intervention patient responses to the Dietary Screener Questionnaire
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via comparing pre/post- intervention responses to the Dietary Screener Questionnaire. The Dietary Screener Questionnaire has 30 questions. There is a scoring algorithm that converts the responses to estimates of dietary intake of fruits and vegetables, dairy, added sugar, whole grain, fiber, and calcium. Changes between pre and post intervention will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
Measured: Baseline and post-intervention assessment (an average of 3 weeks)
Comparison of pre/post-intervention patient responses to the Arizona Activity Questionnaire
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via comparing Arizona Activity Questionnaire. The Arizona Activity Questionnaire has 14 sections with 77 line items. There is a formula that converts the responses to estimates of total energy expenditure and physical activity energy expenditure. Changes between pre and post intervention will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
Measured: Baseline and post-intervention assessment (an average of 3 weeks)
Assessing biosample collection rates: percentage of patients completing blood and tissue sample collection
Primary endpoint: determining feasibility of the prehabilitation intervention by assessing percentage of patients who complete blood and tissue sample collections. Biosample collection rates (plasma and tissue) will be estimated as the proportion of patients who provide biospecimens at the pre- and post-intervention visits, with exact 95% binomial confidence intervals.
Measured: Baseline and post-intervention assessment (an average of 3 weeks)
Secondary outcomes (5)
Assess stability of anthropometric measures: blood pressure
Blood pressure is measured in units of millimeters of mercury (mmHg). Pre/post intervention changes will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
Measured: Baseline and post-intervention assessment (an average of 3 weeks)
Assess stability of anthropometric measures: weight
Weight will be measured in kilograms. Pre/post intervention changes will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
Measured: Baseline and post-intervention assessment (an average of 3 weeks)
Assess stability of anthropometric measures: waist circumference
Waist circumference will be measured in centimeters. Pre/post intervention changes will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
Measured: Baseline and post-intervention assessment (an average of 3 weeks)
Assess changes between pre and post intervention levels of serum biomarkers.
Serum biomarkers [including CRP, IL-6, IL-10, TNFa, IGF-1, VEGF, complete blood count (CBC) with differential, comprehensive metabolic panel (CMP), and prealbumin] will be quantified with ELISA. Changes in serum biomarker levels will be estimated using 95% confidence intervals.
Measured: 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.
Tissue biomarkers [including Ki67, insulin receptor, TNFa, NFKB, NOS2, cleaved caspase 3] will be quantified with ELISA. Changes in tissue biomarker levels will be estimated using 95% confidence intervals.
Measured: Baseline and post-intervention assessment (an average of 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start13 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jennifer Erdrich, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644560
- Sponsor's protocol ID
- STUDY00004848
- Other IDs
- K08CA276137
- Status last verified
- Apr 2026
- First submitted
- 2 Oct 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutrition and Exercise Prehabilitation Intervention on Inflammatory Biomarkers in American Indian Cancer Patients
- ClinicalTrials.gov ID
- NCT06644560
- Acronym / sponsor ID
- STUDY00004848
- Conditions
- Cancer
- Keywords
- Nutrition and Exercise Prehabilitation Intervention, Inflammatory biomarkers, Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation Intervention | Experimental | Behavioral: Prehabilitation InterventionThis is a single-arm, pre-post, window of opportunity trial. The tailored prehab program will be implemented for AI cancer patients preparing for cancer treatment for a 3-week duration prior to their first treatment. 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 cancer, scheduled at least 3 weeks out from cancer treatment who are receiving care at SCAHC 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation InterventionAlso: Prehab InterventionThe 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, a pedometer, and educational materials. The participants will track their completion of tasks with a daily log and the study coordinator will also track their attendance at scheduled nutrition and fitness sessions. In addition, the study coordinator will check-in with participants twice weekly and send text reminders about their required activities. | Behavioural | Prehabilitation Intervention |
Primary outcome
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)
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via patient enrollment and retention. Patient retention will be estimated as the proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurements, with an exact 95% binomial confidence interval.
Adherence to study protocol: compliance with intervention foods (walnuts)
Time frame: 3 weeks during participant's preoperative window
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via compliance with intervention foods (walnuts). Compliance with intervention foods (walnuts) will be estimated as the number of daily packets eaten/number distributed, with an exact 95% binomial confidence interval.
Adherence to study protocol: compliance with exercise recommendations
Time frame: 3 weeks during participant's preoperative window
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via compliance with exercise recommendations. Compliance with exercise recommendations will be estimated as the increase in daily steps (as measured by pedometers) post- versus pre-intervention using a 95% confidence interval.
Assessing patient acceptability via exit interviews to solicit patient experience and feedback
Time frame: 3 weeks during participant's post-intervention assessment
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via exit interviews. The exit interviews will provide qualitative data for assessment. The interview transcriptions will be coded and themed. Themes will be vetted with SCAHC staff to ensure shared understanding of concepts and accurate representation of community perspective.
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)
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via the 6 Minute Walk Test scores. The score of the 6MWT is the distance a patient walks in 6 minutes. Pre/post intervention performance changes on the 6MWT will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
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)
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via the sit-to-stand test scores. The sit-to-stand test score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand). Pre/post intervention performance changes on the sit-to-stand test will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
Comparison of pre/post-intervention patient responses to the Dietary Screener Questionnaire
Time frame: Baseline and post-intervention assessment (an average of 3 weeks)
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via comparing pre/post- intervention responses to the Dietary Screener Questionnaire. The Dietary Screener Questionnaire has 30 questions. There is a scoring algorithm that converts the responses to estimates of dietary intake of fruits and vegetables, dairy, added sugar, whole grain, fiber, and calcium. Changes between pre and post intervention will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
Comparison of pre/post-intervention patient responses to the Arizona Activity Questionnaire
Time frame: Baseline and post-intervention assessment (an average of 3 weeks)
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via comparing Arizona Activity Questionnaire. The Arizona Activity Questionnaire has 14 sections with 77 line items. There is a formula that converts the responses to estimates of total energy expenditure and physical activity energy expenditure. Changes between pre and post intervention will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
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)
Primary endpoint: determining feasibility of the prehabilitation intervention by assessing percentage of patients who complete blood and tissue sample collections. Biosample collection rates (plasma and tissue) will be estimated as the proportion of patients who provide biospecimens at the pre- and post-intervention visits, with exact 95% binomial confidence intervals.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa Carton contact
Jennifer Erdrich, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation Intervention in people with Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Erdrich, MD ((520) 626-2635, jerdrich@surgery.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.