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

Early Phase 1CompletedNCT04073381

University of Texas at Austin92 enrolled

Overview

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.

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Prehabilitation

Interventions

Prehabilitation ProgramCOMBINATION_PRODUCT

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cardiovascular Aging Research Laboratory at UT Austin

Austin, Texas, United States

Outcomes

Primary Outcomes

Hospital Measures- Length of hospital stay

Length of hospital stay

Time frame: Through study completion, an average 1year

Hospital Measures- Emergency room visits

emergency room visits

Time frame: Through study completion, an average 1 year

Hospital Measures- Readmission

Readmission

Time frame: Through study completion, an average 1 year

Hospital Measures

Mortality

Time frame: Through study completion, an average 1 year

Secondary Outcomes

Physical Fitness- Hand Grip

Hand grip dynamometry

Time frame: Baseline, 4 weeks, and 8 weeks

Physical Fitness- 6MWT

6 minute walk test

Time frame: Baseline and 4 weeks

Physical Fitness- TUG

Timed up and go

Time frame: Baseline, 4 weeks, and 8 weeks

Physical Fitness- SPPB

Short Physical Performance Battery Assessing Lower Extremity Function

Time frame: Baseline and 4 weeks

Body Composition

DXA (dual energy X-ray absorptiometry) will be used to assess body composition.

Data from ClinicalTrials.gov

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