← Back to Search

Prehabilitation for Pancreatic Cancer

N/A

Waitlist Available

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Inability to provide own informed consent

Inability to read or verbally understand questionnaires in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks after the surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at a new way to prepare people for surgery to remove pancreatic or periampullary neoplasms.

Who is the study for?

This trial is for adults over 18 who need pancreatic surgery for tumors near the pancreas or periampullary carcinoma. They must be able to exercise, follow a nutrition plan, and communicate in English. People with urgent surgical needs, conditions preventing exercise, or sensory impairments that hinder communication or make exercising unsafe cannot join.

What is being tested?

The study tests a pre-surgery program including quitting smoking, behavioral medicine techniques, physical exercises, and nutritional guidance. Participants are randomly assigned to different combinations of these interventions before their pancreatic surgery.

What are the potential side effects?

Potential side effects may include typical risks associated with lifestyle changes such as muscle soreness from exercise or stress due to dietary adjustments. However, specific side effects will depend on each participant's health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18, can care for myself, and have a low to moderate risk from surgery.

Select...

I need surgery for a tumor in or near my pancreas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand and give consent for my own treatment.

Select...

I cannot read or understand English well enough to complete questionnaires.

Select...

I need surgery urgently due to an emergency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks after the surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks after the surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks after the surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Morbidity rate

Mortality Rate

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

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Arm (Prehabilitation)Experimental Treatment4 Interventions

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.

Group II: Control Arm (Standard of Care)Active Control2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Smoking Cessation

2008

N/A

~5880

Behavioral Medicine

2022

N/A

~30