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

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Prehabilitation

Treatments: Combination Product: Prehabilitation Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04073381

2018-08-0110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

Prehabiliation Program

Experimental group

Description:

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.

Treatment:

Combination Product: Prehabilitation Program