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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
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 belowSelect...
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
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 moreTrial 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
Nutritional
2022
N/A
~80
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
463 Previous Clinical Trials
32,507 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgery is planned for at least 2 weeks after my first surgical check.You have a vision problem that could make exercise unsafe for you.You have other health conditions that make it impossible for you to exercise.I am over 18, can care for myself, and have a low to moderate risk from surgery.I need surgery for a tumor in or near my pancreas.I am unable to understand and give consent for my own treatment.I cannot read or understand English well enough to complete questionnaires.I need surgery urgently due to an emergency.You have trouble hearing on the phone, which makes it difficult for you to have follow-up calls.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm (Standard of Care)
- Group 2: Intervention Arm (Prehabilitation)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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