Clinical trial NCT04073381: Application of Ergogenic Aids to the Prehabilitation of Abdominal Cancer Patients Undergoing Cancer Surgery
Official title: Application of Ergogenic Aids to the Prehabilitation of Abdominal Cancer Patients Undergoing Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Prehabilitation
Keywords: Blood Flow Restriction Training
Ergogenic Aids
Abdominal Cancer
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2019-08-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 100 subjects between the ages of 18 and 90, who have GI cancer and will undergo surgery will be recruited for this study. 100 is an arbitrary number of participants. Due to this study design not being previously use before power analysis calculations were unable to made for key variables. All subjects will participate in the study design.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Hospital Measures- Length of hospital stay
timeFrame: Through study completion, an average 1year
measure: Hospital Measures- Emergency room visits
timeFrame: Through study completion, an average 1 year
measure: Hospital Measures- Readmission
timeFrame: Through study completion, an average 1 year
measure: Hospital Measures
timeFrame: Through study completion, an average 1 year
Secondary outcomes:
measure: Physical Fitness- Hand Grip
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Physical Fitness- 6MWT
timeFrame: Baseline and 4 weeks
measure: Physical Fitness- TUG
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Physical Fitness- SPPB
timeFrame: Baseline and 4 weeks
measure: Body Composition
timeFrame: Baseline and 4 weeks
measure: Blood Work- AA
timeFrame: Baseline and 4 weeks
measure: Blood Work- CRP
timeFrame: Baseline and 4 weeks
measure: Blood Work- IL6
timeFrame: Baseline and 4 weeks
measure: Blood Work- TNFalpha
timeFrame: Baseline and 4 weeks
measure: Questionnaires- Health Status
timeFrame: Baseline
measure: Questionnaires- IPAQ
timeFrame: Baseline and 8 weeks
measure: Questionnaires- SF36
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Questionnaires- MMSE
timeFrame: Baseline
measure: Questionnaires- FESI
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Questionnaires- Nutrition
timeFrame: Baseline
measure: Questionnaires- Charlson Comorbidity
timeFrame: Baseline
measure: Questionnaires- BSCI
timeFrame: Baseline
measure: Questionnaires- Edmonton Frailty
timeFrame: Baseline
measure: Questionnaires- ECOG
timeFrame: Baseline
measure: Questionnaires- Clock Test
timeFrame: Baseline
measure: Accerlometry
timeFrame: Through study completion, an average of one year
Other outcomes:
Locations:
city: Austin
country: United States
facility: Cardiovascular Aging Research Laboratory at UT Austin
state: Texas
Study officials:
References:
citation: 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.