Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms

Pancreatic Neoplasms Clinical Trial

Official title:

Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for Patients With Pancreatic and Periampullary Neoplasms

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05225038
• Other study ID #: CASE8221
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Neoplasms
• Pancreatic Neoplasms
• Periampullary Carcinoma

Intervention

Other:
• Exercise
Participants will meet with an exercise physiologist to undergo evaluation and develop individualized regimens for prehabilitation.

Dietary Supplement:
• Nutritional
Participants will meet with a nutritionist to undergo evaluation and develop individualized regimens for prehabilitation.

Behavioral:
• Behavioral Medicine
Participants will have 1 appointment with behavioral medicine - all participants will meet with the same behavioral medicine specialist to ensure consistency. Participants will receive education regarding factors that affect postoperative recovery and relaxation techniques. Participants will also have the option to request faith support.
• Smoking Cessation
Participants who are actively smoking will be counseled regarding smoking cessation during their preoperative appointment with a member of the surgical team. They will also be offered a referral to smoking cessation resources.

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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