152 Participants Needed

Exercise and Behavioral Training for Pancreatic Cancer

MH
Overseen ByMatthew H. Katz, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Multimodal Exercise and Behavioral Skills Training for pancreatic cancer?

Research shows that exercise programs for pancreatic cancer patients can improve physical function, reduce cancer-related fatigue, and lessen psychological distress. These benefits suggest that incorporating exercise and behavioral training may help patients manage symptoms and improve their overall well-being during treatment.12345

Is exercise and behavioral training safe for people with pancreatic cancer?

Exercise programs for pancreatic cancer patients, including low- to moderate-intensity resistance and aerobic exercises, have been shown to be safe with no reported exercise-related adverse events. These programs are generally well-tolerated and may improve physical and psychological outcomes.23567

How is the Multimodal Exercise and Behavioral Skills Training treatment different from other treatments for pancreatic cancer?

This treatment is unique because it combines exercise and behavioral skills training to improve physical function and psychological well-being in pancreatic cancer patients. Unlike traditional treatments that focus solely on medical interventions, this approach aims to enhance quality of life and manage cancer-related fatigue through structured physical activity and mental health support.12345

What is the purpose of this trial?

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.The goal of this clinical research study is to learn if regular exercise and behavioral skills training can help to improve physical activity in patients with pancreatic cancer who are scheduled to receive chemotherapy and/or radiation before standard-of-care surgery.This is an investigational study.Up to 128 participants will be enrolled on this study. All will take part at MD Anderson.

Research Team

MH

Matthew H. Katz, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals with any type of biopsy-proven pancreatic cancer, who are set to receive pre-surgery chemotherapy and/or radiation. Participants must understand the study, be willing to maintain exercise logs, have phone or email access for communication, and not start surgery within 6 weeks from joining.

Inclusion Criteria

Able to understand the exercise program
I am scheduled for preoperative therapy, including chemotherapy or radiation.
My pancreatic cancer diagnosis was confirmed through a biopsy.
See 5 more

Exclusion Criteria

Unable to complete the baseline assessment questionnaires or functional assessments
My pain level is 7 or higher on a scale of 1 to 10.
My cancer has come back after surgery.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Therapy

Participants receive chemotherapy and/or radiation before surgery

Varies based on individual treatment plans
Regular visits as per chemotherapy/radiation schedule

Surgery and Recovery

Participants undergo standard-of-care surgery and initial recovery

3-6 weeks post-surgery
1 visit (in-person) for surgery and follow-up

Exercise and Behavioral Training

Participants in Arm B engage in structured exercise and behavioral skills training

Up to 7 months post-surgery
Weekly phone calls for the first 4 weeks, then bi-weekly

Follow-up

Participants are monitored for fitness, quality of life, and tumor vasculature changes

3-7 months post-surgery
Regular assessments and questionnaires

Treatment Details

Interventions

  • Multimodal Exercise and Behavioral Skills Training
Trial Overview The PancFit study tests if a program combining regular exercise and behavioral skills training can boost physical activity in pancreatic cancer patients awaiting standard-of-care surgery after chemo/radiation therapy. It includes questionnaires, counseling, and physical assessments.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm B: Multi-Modal Exercise and Nutrition Program (MMENP)Experimental Treatment5 Interventions
After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers. Participants complete moderate-intensity aerobic exercise 5 days each week. Participants complete strength training exercises 2 times per week. Participants contacted by phone by member of study staff 1 time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing.
Group II: Arm A: Standard of Care (SOC)Experimental Treatment4 Interventions
After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers. Participants encouraged to remain active during chemotherapy and/or radiation. Participants receive a booklet that contains a stretching guide with full-body stretches and safety.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Findings from Research

A randomized trial involving 151 patients with pancreatic cancer showed that both a prescribed exercise program and enhanced usual care led to significant improvements in walking distance, with Arm B (exercise) showing a greater mean increase of 27.3 meters compared to 18.6 meters in Arm A (usual care).
While both groups had similar overall activity levels, Arm B participants increased their strength training sessions significantly more, indicating that a structured exercise program can enhance physical fitness in patients preparing for surgery.
Effects of a Pragmatic Home-based Exercise Program Concurrent With Neoadjuvant Therapy on Physical Function of Patients With Pancreatic Cancer: The PancFit Randomized Clinical Trial.Ngo-Huang, AT., Parker, NH., Xiao, L., et al.[2023]
A systematic review of 7 trials involving 201 patients with pancreatic cancer showed that exercise training is safe and feasible, with no reported adverse events and high retention rates (71% to 90%).
Exercise programs led to significant improvements in cancer-related fatigue, psychological distress, and physical function, suggesting that exercise may positively impact the health and well-being of patients with pancreatic cancer.
Exercise Medicine in the Management of Pancreatic Cancer: A Systematic Review.Luo, H., Galvão, DA., Newton, RU., et al.[2023]
In a study involving 20 patients with potentially resectable pancreatic adenocarcinoma, 75% adhered to a home-based exercise program during preoperative chemotherapy, reporting an average of 156 minutes of exercise weekly.
The exercise program was safe, with no adverse events reported, and significantly increased physical activity levels in patients who initially had low baseline activity, suggesting that exercise can be effectively integrated into treatment for pancreatic cancer.
Home-based exercise during preoperative therapy for pancreatic cancer.Ngo-Huang, A., Parker, NH., Wang, X., et al.[2023]

References

Effects of a Pragmatic Home-based Exercise Program Concurrent With Neoadjuvant Therapy on Physical Function of Patients With Pancreatic Cancer: The PancFit Randomized Clinical Trial. [2023]
Exercise Medicine in the Management of Pancreatic Cancer: A Systematic Review. [2023]
Feasibility and efficacy of a multicomponent exercise medicine programme in patients with pancreatic cancer undergoing neoadjuvant therapy (the EXPAN trial): study protocol of a dual-centre, two-armed phase I randomised controlled trial. [2021]
Factors Influencing Exercise Following Pancreatic Tumor Resection. [2021]
Home-based exercise during preoperative therapy for pancreatic cancer. [2023]
Evaluation of a Clinic-Based Exercise Program in Patients with Pancreatic Cancer Undergoing Nonsurgical Treatment. [2023]
Effect of exercise on pancreatic cancer patients during treatment: a scoping review of the literature. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security