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

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: Completed
• Conditions: Prehabilitation
• Intervention / Treatment: Combination product: Prehabilitation Program

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: Interventional
• Enrollment (Actual): 92
• Phase: Early Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Hospital Measures- Length of hospital stay	Length of hospital stay	Through study completion, an average 1year
Hospital Measures- Emergency room visits	emergency room visits	Through study completion, an average 1 year
Hospital Measures- Readmission	Readmission	Through study completion, an average 1 year
Hospital Measures	Mortality	Through study completion, an average 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Fitness- Hand Grip	Hand grip dynamometry	Baseline, 4 weeks, and 8 weeks
Physical Fitness- 6MWT	6 minute walk test	Baseline and 4 weeks
Physical Fitness- TUG	Timed up and go	Baseline, 4 weeks, and 8 weeks
Physical Fitness- SPPB	Short Physical Performance Battery Assessing Lower Extremity Function	Baseline and 4 weeks
Body Composition	DXA (dual energy X-ray absorptiometry) will be used to assess body composition.	Baseline and 4 weeks
Blood Work- AA	Amino Acids	Baseline and 4 weeks
Blood Work- CRP	C-Reactive protein (CRP)	Baseline and 4 weeks
Blood Work- IL6	Interleukin 6 (IL-6)	Baseline and 4 weeks
Blood Work- TNFalpha	TNF-alpha	Baseline and 4 weeks
Questionnaires- Health Status	Health research questionnaire; self reported medical and health history of participant.	Baseline
Questionnaires- IPAQ	International Physical Activity Questionnaire; self reported time, frequency and duration of physical activity within the last 7 days.	Baseline and 8 weeks
Questionnaires- SF36	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	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	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	Dietary Food and Supplement Intake; self reported nutrition intake from 2 weekdays and one weekend.	Baseline
Questionnaires- Charlson Comorbidity	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	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	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	Eastern Cooperative Oncology Group Performance Status; Determines ability of patient to tolerate therapies in serious illness, specifically for chemotherapy.	Baseline
Questionnaires- Clock Test	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	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

• Sponsor: University of Texas at Austin

Publications and helpful links

General Publications

• Wooten SV, Wolf JS Jr, Mendoza D, Bartholomew JB, Stanforth PR, Stanforth D, Tanaka H, Fleming RYD. The Impact of a Multimodal Sport Science-Based Prehabilitation Program on Clinical Outcomes in Abdominal Cancer Patients: A Cohort Study. Am Surg. 2022 Sep;88(9):2302-2308. doi: 10.1177/00031348221103657. Epub 2022 May 24.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2018
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Abdominal Cancer; Blood Flow Restriction Training; Ergogenic Aids
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Abdominal Neoplasms
• Other Study ID 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