Application of Ergogenic Aids to the Prehabilitation of Abdominal Cancer Patients Undergoing Cancer Surgery

July 4, 2021 updated by: Hirofumi Tanaka, University of Texas at Austin
The purpose of the proposed study is to measure surgical recovery, including the length of hospital stay, incidence of perioperative complications, and mortality at 90 days post-surgery, in surgical patients with abdominal cancer. The investigators hypothesize that this prehabilitation program will improve recovery and reduce perioperative complications via the proposed prehabilitation intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators propose that steps to augment and optimize the effectiveness of prehabilitation interventions for abdominal cancer patients may be found in the field of sport science. The investigators have identified two primary strategies to improve and optimize prehabilitation in patients with abdominal cancer: exercise and nutritional supplementation. A home-based exercise program incorporating both walking and resistance training will be performed with blood flow restriction training (BFR). BFR is a cutting-edge training modality that works by restricting blood flow out of the veins by using compression devices similar to traditional blood pressure cuffs (1). This training modality is frequently used by injured athletes for enhanced recovery (2). Muscle hypertrophy and increased muscle strength are more robust and achievable with BFR, even if exercises are performed at low to moderate intensities (2). Additionally, the implementation of a sports nutrition supplement cocktail, which will be provided simultaneously with the 4-week BFR exercise intervention, was developed to augment the effects of resistance exercise by increasing overall anabolism (3) and to remedy the catabolic state that cancer patients often experience (4). The nutrition supplement cocktail will include whey protein, creatine monohydrate, and L-citrulline.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • Cardiovascular Aging Research Laboratory at UT Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients certified by a surgeon to participate in this study;
  • Patients between the ages of 18 and 90;
  • Patients with GI cancer.

Exclusion Criteria: Patients with

  • Uncontrolled or active angina;
  • New York Heart Association Class 3 or 4 heart failure;
  • A myocardial infarction within the last 6 months;
  • Severe/ uncontrolled hypertension (systolic pressure ≥180 mmHg or diastolic pressure ≥120mmHg);
  • Uncontrolled diabetes (fasting blood glucose >400 mg/dL);
  • American Society of Anesthesiologists (ASA) health status grade IV-V.
  • Severe orthopedic conditions that prohibit or impede exercise;
  • Wheelchair dependence;
  • Co-morbid medical conditions interfering with the ability to perform exercise; -Severely impaired ambulation (i.e. patients with uncontrolled neuromuscular disorders);
  • History of Acute Deep Venous Thrombosis within the last 6 months;
  • Inability to comply with exercise instructions upon evaluation; or
  • Inability to provide an informed consent (dementia);
  • Taking medication/supplements containing nitrites/nitrates;
  • With allergies to creatine monohydrate;
  • With allergies or intolerance to artificial sweeteners such as Sucralose, Xylitol, Aspartame, or Stevia;
  • Simultaneous participation in a pharmacotherapy trial;
  • Estimated glomerular filtration rate (EGFR) < 30 and not currently on dialysis.
  • Pregnant or lactating women
  • Dementia
  • Mini Mental State Examination score of Severe Impairment (≤17), or
  • Patients with severe depression.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prehabiliation Program
100 subjects between the ages of 18 and 90, who have GI cancer and will undergo surgery will be recruited for this study ad participate in the prescribed prehabilitation exercise and nutrition program.
Combination product: Prehabilitation Program
This is a 4 week prehabilitation program which uses both exercise and nutrition. Exercise will be prescribed at least 6 days a week. Three days a week , for 45 mins, participants will be asked to perform body, leg and arm exercises against light resistance while wearing pneumatic blood flow restriction arm and leg bands. minutes. On the alternate days participants will walk approximately 15 minutes while wearing the leg bands that restrict blood flow. Additionally, a nutrition supplement cocktail will be provided and should be taken every day within 1 hour after completing each exercise session. The 4 Week Nutrition (Sports Drink) Supplement Cocktail: will include whey protein (25 g/day), creatine monohydrate (8 g/day), and L-citrulline (5 g/day). The supplement mixture will be provided in daily packages by the investigators (nutrition supplements are not regulated by the FDA)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hospital Measures- Length of hospital stay
Time Frame: Through study completion, an average 1year
Length of hospital stay
Through study completion, an average 1year
Hospital Measures- Emergency room visits
Time Frame: Through study completion, an average 1 year
emergency room visits
Through study completion, an average 1 year
Hospital Measures- Readmission
Time Frame: Through study completion, an average 1 year
Readmission
Through study completion, an average 1 year
Hospital Measures
Time Frame: Through study completion, an average 1 year
Mortality
Through study completion, an average 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical Fitness- Hand Grip
Time Frame: Baseline, 4 weeks, and 8 weeks
Hand grip dynamometry
Baseline, 4 weeks, and 8 weeks
Physical Fitness- 6MWT
Time Frame: Baseline and 4 weeks
6 minute walk test
Baseline and 4 weeks
Physical Fitness- TUG
Time Frame: Baseline, 4 weeks, and 8 weeks
Timed up and go
Baseline, 4 weeks, and 8 weeks
Physical Fitness- SPPB
Time Frame: Baseline and 4 weeks
Short Physical Performance Battery Assessing Lower Extremity Function
Baseline and 4 weeks
Body Composition
Time Frame: Baseline and 4 weeks
DXA (dual energy X-ray absorptiometry) will be used to assess body composition.
Baseline and 4 weeks
Blood Work- AA
Time Frame: Baseline and 4 weeks
Amino Acids
Baseline and 4 weeks
Blood Work- CRP
Time Frame: Baseline and 4 weeks
C-Reactive protein (CRP)
Baseline and 4 weeks
Blood Work- IL6
Time Frame: Baseline and 4 weeks
Interleukin 6 (IL-6)
Baseline and 4 weeks
Blood Work- TNFalpha
Time Frame: Baseline and 4 weeks
TNF-alpha
Baseline and 4 weeks
Questionnaires- Health Status
Time Frame: Baseline
Health research questionnaire; self reported medical and health history of participant.
Baseline
Questionnaires- IPAQ
Time Frame: Baseline and 8 weeks
International Physical Activity Questionnaire; self reported time, frequency and duration of physical activity within the last 7 days.
Baseline and 8 weeks
Questionnaires- SF36
Time Frame: Baseline, 4 weeks, and 8 weeks
SF-36 Quality of Life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Baseline, 4 weeks, and 8 weeks
Questionnaires- MMSE
Time Frame: Baseline
Mini Mental State Examination (MMSE) 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Score is reported as 0-30 . 24-30 indicates no cognitive impairment, 18-23 indicates mild cognitive impairment, and 0-17 indicates severe cognitive impairment.
Baseline
Questionnaires- FESI
Time Frame: Baseline, 4 weeks, and 8 weeks
Falls Efficacy Scale-International; items are summed to calculate a range of total score from minimum 16 to maximum 64. The higher the score the greater the fear of falling.
Baseline, 4 weeks, and 8 weeks
Questionnaires- Nutrition
Time Frame: Baseline
Dietary Food and Supplement Intake; self reported nutrition intake from 2 weekdays and one weekend.
Baseline
Questionnaires- Charlson Comorbidity
Time Frame: Baseline
Charlson Comorbidity Index predicts the one-year mortality for a patient who may have a range of comorbid conditions, such as heart disease, AIDS, or cancer (a total of 22 conditions). Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality.
Baseline
Questionnaires- BSCI
Time Frame: Baseline
Brief Screen for Cognitive Impairment (BSCI); Scores are weighted and summed to arrive at final score. Delayed recall and medication help each get a weight of 2.0, and errand help gets a weight of 1.0. If client does not take any medications, the weighted scores of the other two items perform similarly to the three-item version. Higher scores indicate greater frailty/cognitive impairment.
Baseline
Questionnaires- Edmonton Frailty
Time Frame: Baseline
Edmonton Frailty Assessment; consists of nine domains and eleven items, each scoring 0 points (frailty absent or normal health), 1 point (minor errors or mild/moderate impairment), or 2 points (important errors or severely impaired). Higher scores indicate greater frailty.
Baseline
Questionnaires- ECOG
Time Frame: Baseline
Eastern Cooperative Oncology Group Performance Status; Determines ability of patient to tolerate therapies in serious illness, specifically for chemotherapy.
Baseline
Questionnaires- Clock Test
Time Frame: Baseline
Clock Test; evaluates three items: "correctly drawn clock shape," "all numbers in the correct position," and "hands of the clock set to the correct time." A score of 1 was assigned for each of these items. Higher scores indicate greater frailty/cognitive impairment.
Baseline
Accerlometry
Time Frame: Through study completion, an average of one year
Accelerometer/ Pedometer Measurement will be used to measure activity levels for 7 days immediately post surgery.
Through study completion, an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-08-0110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be reported as average group means.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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