Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Periampullary Carcinoma; Pancreatic Neoplasms

Treatments: Other: Exercise; Dietary Supplement: Nutritional; Behavioral: Behavioral Medicine; Behavioral: Smoking Cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT05225038

CASE8221

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

23 participants in 2 patient groups

Control Arm (Standard of Care)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Smoking Cessation

Behavioral: Behavioral Medicine

Intervention Arm (Prehabilitation)

Experimental group

Description:

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.

Treatment:

Behavioral: Smoking Cessation

Behavioral: Behavioral Medicine

Dietary Supplement: Nutritional

Other: Exercise