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

Prehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073381
• Other study ID #: 2018-08-0110
• Status: Completed
• Phase: Early Phase 1
• Start date: October 28, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: July 2021
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Neoplasms
• Prehabilitation

Intervention

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)

Locations

Country	Name	City	State
United States	Cardiovascular Aging Research Laboratory at UT Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Measures- Length of hospital stay	Length of hospital stay	Through study completion, an average 1year
Primary	Hospital Measures- Emergency room visits	emergency room visits	Through study completion, an average 1 year
Primary	Hospital Measures- Readmission	Readmission	Through study completion, an average 1 year
Primary	Hospital Measures	Mortality	Through study completion, an average 1 year
Secondary	Physical Fitness- Hand Grip	Hand grip dynamometry	Baseline, 4 weeks, and 8 weeks
Secondary	Physical Fitness- 6MWT	6 minute walk test	Baseline and 4 weeks
Secondary	Physical Fitness- TUG	Timed up and go	Baseline, 4 weeks, and 8 weeks
Secondary	Physical Fitness- SPPB	Short Physical Performance Battery Assessing Lower Extremity Function	Baseline and 4 weeks
Secondary	Body Composition	DXA (dual energy X-ray absorptiometry) will be used to assess body composition.	Baseline and 4 weeks
Secondary	Blood Work- AA	Amino Acids	Baseline and 4 weeks
Secondary	Blood Work- CRP	C-Reactive protein (CRP)	Baseline and 4 weeks
Secondary	Blood Work- IL6	Interleukin 6 (IL-6)	Baseline and 4 weeks
Secondary	Blood Work- TNFalpha	TNF-alpha	Baseline and 4 weeks
Secondary	Questionnaires- Health Status	Health research questionnaire; self reported medical and health history of participant.	Baseline
Secondary	Questionnaires- IPAQ	International Physical Activity Questionnaire; self reported time, frequency and duration of physical activity within the last 7 days.	Baseline and 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Questionnaires- Nutrition	Dietary Food and Supplement Intake; self reported nutrition intake from 2 weekdays and one weekend.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Questionnaires- ECOG	Eastern Cooperative Oncology Group Performance Status; Determines ability of patient to tolerate therapies in serious illness, specifically for chemotherapy.	Baseline
Secondary	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
Secondary	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