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Behavioral Intervention
Video-based Exercise Prehabilitation for Pancreatic Cancer
Phase 3
Recruiting
Led By An Ngo-Huang, DO
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up thorugh study completion; an average of 1 year.
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing if an exercise program can help pancreatic cancer patients by improving their health.
Who is the study for?
This trial is for adults over 18 with resectable pancreatic cancer, scheduled for chemo followed by surgery. They must be able to do fitness tests and follow the Tele-PancFit exercise program, have Wi-Fi at home for remote sessions, and not be in severe pain or have unstable heart/lung conditions.
What is being tested?
The study compares usual care with a tele-supervised resistance exercise program (Tele-PancFit) during chemotherapy to see if it improves outcomes for patients undergoing treatment for pancreatic cancer.
What are the potential side effects?
While specific side effects are not listed, typical risks of resistance exercises may include muscle soreness, fatigue, and potential strain on the heart or lungs especially in those with pre-existing conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ thorugh study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~thorugh study completion; an average of 1 year.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and adverse events (AEs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group B-Tele-supervised resistance exercisesExperimental Treatment1 Intervention
Participants will take part in a monitored exercise program. The study team will provide more instructions and information about the program
Group II: Group A-Enhanced Usual CareExperimental Treatment1 Intervention
Participants will be given general recommendations to increase physical activity and improve nutrition before surgery.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer include surgery, chemotherapy, and radiation therapy. Surgery aims to remove the tumor and surrounding tissues, potentially offering a cure in early-stage disease.
Chemotherapy uses drugs to kill cancer cells or stop their growth, often by damaging their DNA or interfering with cell division. Radiation therapy uses high-energy rays to target and destroy cancer cells.
Supportive care, such as supervised exercise programs, plays a crucial role by improving physical fitness, reducing treatment-related side effects like fatigue, and potentially enhancing the effectiveness of chemotherapy. This holistic approach is vital for pancreatic cancer patients as it can improve overall quality of life and treatment outcomes.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,128 Total Patients Enrolled
An Ngo-Huang, DOPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am set to undergo chemotherapy before surgery for 2-6 months.I can attend a fitness test and training session at the required location.I do not speak English.I do not have severe heart or lung problems.I have a muscle or joint disease affecting my ability to move.My pain level is 7 or higher on a scale of 0 to 10.I am fully active or can carry out light work.My pancreatic cancer is confirmed and considered operable.I recently had a fracture or injury that stops me from putting weight on all my limbs.
Research Study Groups:
This trial has the following groups:- Group 1: Group A-Enhanced Usual Care
- Group 2: Group B-Tele-supervised resistance exercises
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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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