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Multimodal Prehabilitation for Pancreatic Cancer
N/A
Recruiting
Led By Motaz Qadan, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed within 8 weeks with upfront resectable, borderline resectable, or locally advanced unresectable PDAC as defined by the National Comprehensive Cancer Network (NCCN)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether an exercise and nutrition program during neoadjuvant therapy can improve outcomes for pancreatic cancer patients.
Who is the study for?
This trial is for adults over 18 with a recent diagnosis of resectable or locally advanced pancreatic cancer, who are fluent in English and planning to undergo neoadjuvant chemotherapy and surgery at MGH. Excluded are those with metastatic disease, prior cancer treatments within 5 years, severe physical or cardiovascular limitations, strict dietary restrictions due to allergies/preferences, severe lung conditions, cognitive impairments, or debilitating orthopedic issues.Check my eligibility
What is being tested?
The study tests the effectiveness of a combined exercise and nutrition program during total neoadjuvant therapy (TNT) before surgery in patients with pancreatic ductal adenocarcinoma (PDAC). The goal is to see if this 'prehabilitation' improves outcomes for these patients.See study design
What are the potential side effects?
While not drug-related side effects per se, participants may experience typical risks associated with exercise programs such as muscle strains or sprains. Nutritional interventions could potentially cause digestive discomfort depending on individual tolerances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with a specific type of pancreatic cancer within the last 8 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants to complete prehabilitation program
Trial Design
1Treatment groups
Experimental Treatment
Group I: Multimodal Prehabilitation ProgramExperimental Treatment2 Interventions
Pretreatment exercise program and nutrition program
-The prehabilitation intervention will include the following components: (1) a standardized fitness program and (2) nutritional counseling and optimization. Patients are enrolled in the program within 8 weeks of being diagnosed and continued until operation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Program
2016
Completed Phase 3
~4930
Nutrition Program
2016
N/A
~800
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,405 Total Patients Enrolled
Motaz Qadan, MD, PhDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot eat normally due to allergies, restrictions, or preferences.I am scheduled for surgery to remove pancreatic cancer at MGH.I have severe lung problems like COPD, emphysema, or need extra oxygen.I am scheduled for FOLFIRINOX chemotherapy before surgery.You have a history of problems with your thinking or mental health.I have severe joint pain, amputations, injuries, or chronic pain like fibromyalgia.My cancer has spread to other parts of my body.I was treated for pancreatic cancer and haven't had any cancer therapy in the last 5 years.I use walking aids or a wheelchair due to physical impairment.I do not have uncontrolled high blood pressure, severe heart failure, or a recent heart attack.I am planning to have total neoadjuvant therapy at MGH.I am 18 years old or older.I was diagnosed with a specific type of pancreatic cancer within the last 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Multimodal Prehabilitation Program
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial actively accepting new participants?
"Clinicaltrials.gov states that this clinical study is actively recruiting participants, with the trial first being uploaded to their database on August 13th 2019 and last updated on May 13th 2021."
Answered by AI
What is the total patient count for this research project?
"Correct. According to the information available on clinicaltrials.gov, this medical experiment is currently recruiting patients. The trial was initially published on August 13th 2019 and it has been updated as recently as May 13rd 2021. To fulfill its requirements, 40 participants will be sourced from a single location."
Answered by AI
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