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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01183 | Other Identifier | NCI-CTRP Clinical Trials Reporting Registry |
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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.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study arms. This is done because no one knows if one study arm is better than, the same, or worse than the other group.
If you are in Arm A, you will not take part in a structured exercise program. If you are in Arm B, you will take part in a structured exercise program and behavioral skills training as described below.
Length of Study:
You will continue to take part in this study for up to 7 months after your scheduled standard-of-care surgery. However, if intolerable side effects occur or the disease appears to get worse, the study staff will decide if continuing the exercise program is in your best interest.
Study Visits:
At your baseline visit, after you complete chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery:
If you are in Arm B, one (1) time each week for the first 4 weeks and then every 2 weeks after that, a member of the study staff will contact you by phone for behavioral skills training and to see how you are doing. These calls should last about 15 minutes.
For 2 weeks during each phase of chemotherapy and/or radiation you receive, you will wear a small activity monitor on an elastic band. This will be worn in addition to your Fitbit.
Exercise Programs:
ARM A:
If you are in Arm A, you will be encouraged to remain active during chemotherapy and/or radiation, but you will not receive instruction about aerobic or strengthening exercises. You will receive a booklet that contains a stretching guide with full-body stretches and safety.
ARM B:
If you are in Arm B, you will be asked to complete up to 30 minutes of moderate-intensity aerobic exercise (such as brisk walking, stationary cycling, and/or elliptical or stair stepping machines) for at least 5 days each week.
You will also complete strength training exercises at least 2 times per week. You will complete 1 set of 10-15 repetitions for each of the 8 exercises that you are taught. Over time, the amount of resistance, repetitions, and/or sets may increase or decrease based on your strength. You will be given 5 different resistance tubes to complete these exercises, but you may use free-weights or machines if you prefer.
You should complete warm up exercises and 5 minutes of stretching before and after strength training.
You must keep a daily activity log to document your exercises.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Standard of Care (SOC) | Experimental | 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. |
|
| Arm B: Multi-Modal Exercise and Nutrition Program (MMENP) | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Behavioral | Participants complete 4 questionnaires about physical abilities, motivation, and quality of life They should take about 25 minutes total to complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 Minute Walk Test (6MWT) | Primary endpoint is the change in 6MWT distance, measured in meters, between the time at which preoperative therapy is administered (T0) and the time at which it ends (T1). | Change compared from baseline to date surgery is scheduled |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew H. Katz, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37026453 | Derived | Ngo-Huang AT, Parker NH, Xiao L, Schadler KL, Petzel MQB, Prakash LR, Kim MP, Tzeng CD, Lee JE, Ikoma N, Wolff RA, Javle MM, Koay EJ, Pant SD, Folloder JP, Wang X, Cotto AM, Ju YR, Garg N, Wang H, Bruera ED, Basen-Engquist KM, Katz MHG. 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. Ann Surg. 2023 Jul 1;278(1):22-30. doi: 10.1097/SLA.0000000000005878. Epub 2023 Apr 7. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Nutritional Questionnaire and Nutritional Counseling | Behavioral | Participants complete a nutritional questionnaire and receive nutritional counseling. It should take about 5 minutes to complete. Participants receive educational materials and personalized counseling based on participant's answers. |
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| Booklet | Other | Participants receive a booklet that contains a stretching guide with full-body stretches and safety. |
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| Aerobic Exercise and Strength Training Exercises | Behavioral | Participants complete up to 30 minutes of moderate-intensity aerobic exercise (such as brisk walking, stationary cycling, and/or elliptical or stair stepping machines) for at least 5 days each week. Participants complete strength training exercises at least 2 times per week. |
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| Phone Calls | Behavioral | Participants contacted by phone by member of study staff one (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. These calls should last about 15 minutes. |
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| Physical Assessments | Behavioral | After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participant's hand grip strength measured using a hand-held machine. 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. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D015596 | Nutrition Assessment |
| D015444 | Exercise |
| D006804 | Ergonomics |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015991 | Epidemiologic Measurements |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D004738 | Engineering |
| D013676 | Technology, Industry, and Agriculture |
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