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

NCT ID: NCT04073381

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-28
• Study Completion Date: 2020-08-31

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.

Conditions

Prehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prehabilitation Program

Intervention Type: COMBINATION_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)

Interventions

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)

Intervention Type: COMBINATION_PRODUCT

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Hirofumi Tanaka

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cardiovascular Aging Research Laboratory at UT Austin

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35608376 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2018-08-0110

Identifier Type: -

Identifier Source: org_study_id