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Exercise and Behavioral Training for Pancreatic Cancer

N/A

Waitlist Available

Led By Matthew H. Katz, MD

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

Scheduled to receive preoperative therapy (chemotherapy, radiation or chemoradiation) either on- or off-protocol

Pancreatic cancer of any type, biopsy-proven

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change compared from baseline to date surgery is scheduled

Awards & highlights

Study Summary

This trial is for people with pancreatic cancer who are scheduled to get chemotherapy and/or radiation before surgery. Researchers want to see if regular exercise and behavioral skills training can help improve physical activity for these patients.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves exercise and nutritional guidance rather than medication or invasive procedures, side effects may include typical exercise-related issues such as muscle soreness or strain. Nutritional changes could also cause digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for preoperative therapy, including chemotherapy or radiation.

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My pancreatic cancer diagnosis was confirmed through a biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change compared from baseline to date surgery is scheduled

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change compared from baseline to date surgery is scheduled

This trial's timeline: 3 weeks for screening, Varies for treatment, and change compared from baseline to date surgery is scheduled 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 6 Minute Walk Test (6MWT)

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Questionnaires

2013

Completed Phase 2

~3030

Phone Calls

2015

Completed Phase 2

~430

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,965 Previous Clinical Trials

1,804,765 Total Patients Enrolled

Matthew H. Katz, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

75 Total Patients Enrolled

Media Library

Multimodal Exercise and Behavioral Skills Training Clinical Trial Eligibility Overview. Trial Name: NCT03187951 — N/A

Pancreatic Cancer Research Study Groups: Arm B: Multi-Modal Exercise and Nutrition Program (MMENP), Arm A: Standard of Care (SOC)

Pancreatic Cancer Clinical Trial 2023: Multimodal Exercise and Behavioral Skills Training Highlights & Side Effects. Trial Name: NCT03187951 — N/A

Multimodal Exercise and Behavioral Skills Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT03187951 — N/A

Frequently Asked Questions

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

Are there still openings for enrollees in this experimental study?

"As per the information from clinicaltrials.gov, this medical trial is not open for recruitment at present. Though first posted on June 13th 2017 and last updated 8/2/2022, it has since been closed to new participants; however there are currently 700 other trials actively seeking enrollees."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PancFit: Multimodal Exercise During Preoperative Therapy for Pancreatic Cancer

2017. "PancFit: Multimodal Exercise During Preoperative Therapy for Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03187951.