Clinical trial · Interventional
Application of Ergogenic Aids to the Prehabilitation of Abdominal Cancer Patients Undergoing Cancer Surgery
NCT04073381CI-TRIAL-00052582completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation Program | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prehabiliation Program
- 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.
- interventionNames
- Combination Product: Prehabilitation Program
Primary outcomes (4)
- measure
- Hospital Measures- Length of hospital stay
- timeFrame
- Through study completion, an average 1year
- description
- Length of hospital stay
- measure
- Hospital Measures- Emergency room visits
- timeFrame
- Through study completion, an average 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWooten 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. PMID 35608376