Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Pancreatic Neoplasms; Periampullary Carcinoma
• Intervention / Treatment: Behavioral: Behavioral Medicine; Behavioral: Smoking Cessation; Other: Exercise; Dietary supplement: Nutritional

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm (Standard of Care); Participants will receive the current standard preoperative education and counseling. Participants will receive information regarding exercise and nutrition from a member of the surgical team. Participants will meet with a behavioral medicine specialist for additional education regarding factors affecting postoperative stress and relaxation techniques. Participants who are actively smoking will be counseled regarding smoking cessation and offered a referral to smoking cessation resources.	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.; Behavioral: 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.
Experimental: Intervention Arm (Prehabilitation); Participants in the intervention arm will receive all of the standard of care, as listed above, as well as individualized exercise and nutritional prehabilitation regimens. During the data analysis, participants will be subdivided into treatment groups, upfront surgical resection versus neoadjuvant chemotherapy, in order to determine whether length of prehabilitation affected outcomes and distinguish any possible effect of chemotherapy toxicity.	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.; Behavioral: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality Rate	Death due to any cause postoperatively.	Up to 90 days after the surgery
Morbidity rate	Classified according to the Clavien-Dindo Classification of postoperative complications.	Up to 90 days after the surgery
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
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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: CASE8221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No