Back to results

Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms

Primary Purpose

Pancreatic Neoplasms, Periampullary Carcinoma

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

Nutritional

Behavioral Medicine

Smoking Cessation

About this trial

This is an interventional supportive care trial for Pancreatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Arm (Standard of Care)

Intervention Arm (Prehabilitation)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality Rate

Death due to any cause postoperatively.

Morbidity rate

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

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.

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.

Full Information

NCT ID

NCT05225038

First Posted

January 10, 2022

Last Updated

May 9, 2023

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05225038

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

June 13, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Neoplasms, Periampullary Carcinoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Arm (Standard of Care)

Arm Type

Active Comparator

Arm Description

Arm Title

Intervention Arm (Prehabilitation)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Nutritional

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Medicine

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Smoking Cessation

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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.

Time Frame

3 weeks after the surgery

Secondary Outcome Measure Information:

Title

Mortality Rate

Description

Death due to any cause postoperatively.

Time Frame

Up to 90 days after the surgery

Title

Morbidity rate

Description

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

Time Frame

Up to 90 days after the surgery

Title

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

Description

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.

Time Frame

3 weeks after the surgery

Title

Physical capacity as represented by 6-Minute Walk Test

Description

Time Frame

3 weeks after the surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms

We'll reach out to this number within 24 hrs