PancFit: Multimodal Exercise During Preoperative Therapy for Pancreatic Cancer

NCT03187951 | Active Not Recruiting

• 2 other identifiers: 2017-0198NCI-2018-01183
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Disorders of Glucose Regulation and Pancreatic Internal Secretion; Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Behavioral: Questionnaires; Behavioral: Nutritional Questionnaire and Nutritional Counseling; Other: Booklet; Behavioral: Physical Assessments

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.

Behavioral: Questionnaires; Behavioral: Nutritional Questionnaire and Nutritional Counseling; Behavioral: Aerobic Exercise and Strength Training Exercises; Behavioral: Phone Calls; Behavioral: Physical Assessments

Interventions

Questionnaires BEHAVIORAL

Participants complete 4 questionnaires about physical abilities, motivation, and quality of life They should take about 25 minutes total to complete.

Also known as: Surveys

Arm A: Standard of Care (SOC); Arm B: Multi-Modal Exercise and Nutrition Program (MMENP)

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.

Arm A: Standard of Care (SOC); Arm B: Multi-Modal Exercise and Nutrition Program (MMENP)

Booklet OTHER

Participants receive a booklet that contains a stretching guide with full-body stretches and safety.

Also known as: Pamphlet, Educational materials

Arm A: Standard of Care (SOC)

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.

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

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.

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

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.

Arm A: Standard of Care (SOC); Arm B: Multi-Modal Exercise and Nutrition Program (MMENP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-English speaking
• Unable to complete the baseline assessment questionnaires or functional assessments
• Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
• 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
• Numeric pain rating scale of \>/= 7 out of 10
• Myopathic or rheumatologic disease that impacts physical function
• Recurrent cancer following prior resection
• Neuroendocrine cancer
• Completed preoperative therapy and are on their presurgical rest period.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 37026453 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Surveys and Questionnaires; Nutrition Assessment; Exercise; Ergonomics

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Epidemiologic Measurements; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Engineering; Technology, Industry, and Agriculture

Study Officials

• Matthew H. Katz, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: June 13, 2017
• Primary Completion: December 31, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)