Pancreatic Neoplasms Clinical Trial
Official title:
Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for Patients With Pancreatic and Periampullary Neoplasms
Verified date | January 2024 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for participants with Pancreatic and Periampullary Neoplasms
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants > 18 years old with ECOG performance status 0-2 and ASA score =3 - Requiring pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms - Surgery scheduled at least 2 weeks after the initial surgical evaluation - Fluency in English - Willingness to answer questionnaires, complete daily exercise & nutrition log, as well as participate in follow-up telephone calls - Screening: Physical Activity Readiness - Questionnaire (PAR-Q+) - PAR-Q+ assesses participants comorbidities and symptoms with current activities. If participants answer "yes" to any of the screening questions, they will need to complete additional questions regarding their chronic medical conditions including, but not limited to, heart disease, stroke, diabetes, depression/anxiety, and COPD/asthma, to determine their ability to participate in physical activity. Exclusion Criteria: - Screening: Physical Activity Readiness - Questionnaire (PAR-Q+) - Participants with concurrent medical conditions that prohibit exercise, such as those who indicate on the questionnaire that they experience chest pain, dizziness, or loss of consciousness with physical activity; those with chest pain at rest; or those with bone/joint/soft tissue conditions that could worsen with physical activity. Participants with specific comorbidities, such as coronary artery disease. congestive heart failure, or uncontrolled asthma/COPD, that may prevent participation will also be excluded. - Inability to provide own informed consent - Inability to read or verbally understand questionnaires in English - Impaired hearing that creates a barrier for telephone follow-up - Visual deficit that would cause exercise to be hazardous - Emergent or urgent surgeries |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in participants physical capacity, as represented by hand grip strength | Previous studies have demonstrated that grip strength is a predictor of surgical outcomes and mortality in cancer participants. Grip strength will be measured utilizing the Jamar Dynamometer. | 3 weeks after the surgery | |
Secondary | Mortality Rate | Death due to any cause postoperatively. | Up to 90 days after the surgery | |
Secondary | Morbidity rate | Classified according to the Clavien-Dindo Classification of postoperative complications. | Up to 90 days after the surgery | |
Secondary | Physical capacity as represented by 30s CST (Chair Stand Test ) | Participants rise to full standing position from sitting in a chair as many times as possible within 30 seconds. The 30s CST has been utilized as a reliable test of lower extremity strength. | 3 weeks after the surgery | |
Secondary | Physical capacity as represented by 6-Minute Walk Test | Participants will walk as far as possible in 6 min at a comfortable pace but do not run or jog. If participants cannot complete the full 6 min walk, then record the time and distance walked and the reason for stopping early. | 3 weeks after the surgery |
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