Clinical trial NCT05225038: Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms
Official title: Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for Patients With Pancreatic and Periampullary Neoplasms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasms
Periampullary Carcinoma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for participants with Pancreatic and Periampullary Neoplasms

Detailed description: Frailty is independently associated with an increased risk of adverse outcomes after major surgery, including pancreatic resection. Prehabilitation aims to optimize modifiable risk factors to improve participants' baseline health prior to surgery. Multiple studies with participants undergoing pancreatic surgery have investigated the impact of prehabilitation on preoperative health metrics as well as postoperative outcomes. The majority of these studies focused only on exercise; if nutritional and/or psychological status were assessed, these dimensions were not intervened upon in prehabilitation regimens or reassessed postoperatively. This randomized controlled trial (RCT) is designed to assess the impact of physical and nutritional prehabilitation on participants' perioperative condition for those undergoing pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms.

Eligibility criteria: 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

Primary outcomes:
measure: Change in participants physical capacity, as represented by hand grip strength
timeFrame: 3 weeks after the surgery
Secondary outcomes:
measure: Mortality Rate
timeFrame: Up to 90 days after the surgery
measure: Morbidity rate
timeFrame: Up to 90 days after the surgery
measure: Physical capacity as represented by 30s CST (Chair Stand Test )
timeFrame: 3 weeks after the surgery
measure: Physical capacity as represented by 6-Minute Walk Test
timeFrame: 3 weeks after the surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
References: