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PancFit: Multimodal Exercise During Preoperative Therapy for Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03187951
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Other Disorders of Glucose Regulation and Pancreatic Internal Secretion Pancreatic Cancer Behavioral: Questionnaires Behavioral: Nutritional Questionnaire and Nutritional Counseling Other: Booklet Behavioral: Aerobic Exercise and Strength Training Exercises Behavioral: Phone Calls Behavioral: Physical Assessments Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PancFit: Multimodal Exercise During Preoperative Therapy for Pancreatic Cancer: A Randomized Trial Testing Effects on Fitness, Health-Related Quality of Life, and Tumor Vasculature
Actual Study Start Date : June 13, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: Standard of Care (SOC)

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.

Behavioral: Questionnaires
Participants complete 4 questionnaires about physical abilities, motivation, and quality of life They should take about 25 minutes total to complete.
Other Name: Surveys

Behavioral: Nutritional Questionnaire and Nutritional Counseling
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.

Other: Booklet
Participants receive a booklet that contains a stretching guide with full-body stretches and safety.
Other Names:
  • Pamphlet
  • Educational materials

Behavioral: Physical Assessments
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.

Experimental: Arm B: Multi-Modal Exercise and Nutrition Program (MMENP)

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.

Behavioral: Questionnaires
Participants complete 4 questionnaires about physical abilities, motivation, and quality of life They should take about 25 minutes total to complete.
Other Name: Surveys

Behavioral: Nutritional Questionnaire and Nutritional Counseling
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.

Behavioral: Aerobic Exercise and Strength Training Exercises
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.

Behavioral: Phone Calls
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.

Behavioral: Physical Assessments
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.




Primary Outcome Measures :
  1. Change in 6 Minute Walk Test (6MWT) [ Time Frame: Change compared from baseline to date surgery is scheduled ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pancreatic cancer of any type, biopsy-proven
  2. Scheduled to receive preoperative therapy (chemotherapy, radiation or chemoradiation) either on- or off-protocol.
  3. Anticipated to undergo pancreatectomy in >/= 6 weeks from enrollment
  4. Able to understand the description of the study and willing to participate
  5. Able to understand the exercise program
  6. Able to maintain daily exercise logs
  7. Telephone or email access and agreement to engage with the research personnel via phone or email
  8. Meet all screening requirements.

Exclusion Criteria:

  1. Non-English speaking
  2. Unable to complete the baseline assessment questionnaires or functional assessments
  3. Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
  4. Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention
  5. Numeric pain rating scale of >/= 7 out of 10
  6. Myopathic or rheumatologic disease that impacts physical function
  7. Recurrent cancer following prior resection
  8. Neuroendocrine cancer
  9. Completed preoperative therapy and are on their presurgical rest period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187951


Contacts
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Contact: Matthew H. Katz, MD 713-792-6940 mhgkatz@mdanderson.org

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Matthew H. Katz, MD       mhgkatz@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Matthew H. Katz, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03187951    
Other Study ID Numbers: 2017-0198
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Other disorders of glucose regulation and pancreatic internal secretion
Pancreatic cancer
Questionnaires
Surveys
Nutritional Questionnaire
Nutritional Counseling
Booklet
Pamphlet
Educational materials
Aerobic Exercise
Strength Training Exercises
Physical Assessments
Walk Test
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases