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Completed

NCT Number: NCT05225038

Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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

Nutritional

Dietary Supplement

Participants will meet with a nutritionist to undergo evaluation and develop individualized regimens for prehabilitation.

Behavioral Medicine

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change in participants physical capacity, as represented by hand grip strength

    Time frame: 3 weeks after the surgery

    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.

Secondary outcomes

  1. Mortality Rate

    Time frame: Up to 90 days after the surgery

    Death due to any cause postoperatively.

  2. Morbidity rate

    Time frame: Up to 90 days after the surgery

    Classified according to the Clavien-Dindo Classification of postoperative complications.

  3. Physical capacity as represented by 30s CST (Chair Stand Test )

    Time frame: 3 weeks after the surgery

    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.

  4. Physical capacity as represented by 6-Minute Walk Test

    Time frame: 3 weeks after the surgery

    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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 4, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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