Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms

NCT05225038 | Completed DMC

• 1 other identifier: CASE8221
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Neoplasms; Periampullary Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mortality Rate

  Up to 90 days after the surgery

• Morbidity rate

  Up to 90 days after the surgery

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

  3 weeks after the surgery

• Physical capacity as represented by 6-Minute Walk Test

  3 weeks after the surgery

Study Arms (2)

Control Arm (Standard of Care)

ACTIVE COMPARATOR

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; Behavioral: Smoking Cessation

Intervention Arm (Prehabilitation)

EXPERIMENTAL

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.

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

Interventions

Exercise OTHER

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

Intervention Arm (Prehabilitation)

Nutritional DIETARY_SUPPLEMENT

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

Intervention Arm (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.

Control Arm (Standard of Care); Intervention Arm (Prehabilitation)

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.

Control Arm (Standard of Care); Intervention Arm (Prehabilitation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Exercise; Behavioral Medicine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavioral Sciences; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 4, 2022
• Study Start: June 13, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)