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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks after the surgery
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in participants physical capacity, as represented by hand grip strength
Secondary outcome measures
Morbidity rate
Mortality Rate
Physical capacity as represented by 30s CST (Chair Stand Test )
+1 more

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
~5860
Nutritional
2013
N/A
~60

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,810 Total Patients Enrolled

Media Library

Nutritional Clinical Trial Eligibility Overview. Trial Name: NCT05225038 — N/A
Pancreatic Cancer Research Study Groups: Control Arm (Standard of Care), Intervention Arm (Prehabilitation)
Pancreatic Cancer Clinical Trial 2023: Nutritional Highlights & Side Effects. Trial Name: NCT05225038 — N/A
Nutritional 2023 Treatment Timeline for Medical Study. Trial Name: NCT05225038 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research effort currently seeking participants?

"According to clinicaltrials.gov, this medical trial has ceased recruitment since its original post date of June 13th 2022 and most recent update on August 3rd 2022. Nonetheless, there are 2906 other studies currently recruiting patients for participation."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms
2022. "Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05225038.
All > Appendix Cancer > Pancreatic Cancer
~8 spots leftby Jun 2024
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