Resistance Training Intervention to Improve Physical Function in Patients With Pancreatic Cancer Receiving Combination Chemotherapy or Have Undergone Surgery, PancStrength Study

Last updated: October 10, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cancer/tumors

Digestive System Neoplasms

Pancreatitis

Treatment

Questionnaire Administration

Quality-of-Life Assessment

Resistance Training

Clinical Study ID

NCT04837118
2020-0147
2020-0147
NCI-2021-02028
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This clinical trial studies the safety of a real-time tele-exercise resistance training (training done using a tablet) in maintaining skeletal muscle, strength, physical function, and health-related quality of life in patients with pancreatic cancer who are receiving combination chemotherapy or have undergone surgery for the treatment of pancreatic cancer. Tele-exercise resistance training may improve physical function and quality of life in patients with pancreatic cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Biopsy-proven pancreatic adenocarcinoma, advanced stage (III-IV) (study 1) ORbiopsy-proven pancreatic adenocarcinoma, at least 10 weeks post-surgical tumorresection and currently with no radiographic evidence of disease on recentcomputerized tomography (CT) scan (study 2)

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

  • Treatment plan of first-line FOLFIRINOX chemotherapy with planned return visit to MDAnderson Main Campus for restaging (study 1) OR plans to return to MDACC forrestaging appointments in 3-4 months, including follow up CT scan (study 2)

  • Able to schedule baseline (T0) appointment for fitness testing and program teachingat the Behavioral Research and Treatment Center (BRTC) or able to schedule remotefitness testing and program teaching

  • Able to understand the description of the study, exercise program, and willing toparticipate

  • Home access to wireless internet (Wi-Fi) and agreement to engage with studypersonnel for real-time tele-RT sessions

  • Age >= 18

  • Meet all screening requirements

  • PROVIDERS (FOR ACCEPTABILITY INTERVENTION): All GI medical oncologists, GI surgeons,advanced practice providers, and clinical dietitians who are involved inparticipants' care and have some interaction with intervention personnel duringrecruitment, referral, scheduling, or follow up will be asked to completequestionnaires assessing intervention acceptability. The exact number of providerswho will be asked to complete questionnaires will depend on whether patients enrollfrom the different GI Medical Oncology and GI Surgery clinics, but we expect 10-20providers to be eligible

Exclusion

Exclusion Criteria:

  • Non-English speaking

  • Has participated in regular RT (RT for all major muscle groups at least twice perweek) throughout the month prior to recruitment

  • Unable to complete the baseline assessment questionnaires or functional assessments

  • Screen failure for exercise safety based on Physical Activity ReadinessQuestionnaire (PAR-Q) and/or Patient Reported Outcomes Measurement InformationSystem (PROMIS) questions

  • Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (NewYork Heart Association functional class III or IV)

  • Recent fracture or acute musculoskeletal injury that precludes the ability to weightbear 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

  • FEMALES ONLY: Known pregnancy, as communicated to study personnel by clinicians ingastrointestinal (GI) Medical Oncology; females of childbearing potential receiveadvice to use methods of contraception per usual care

Study Design

Total Participants: 25
Treatment Group(s): 4
Primary Treatment: Questionnaire Administration
Phase:
Study Start date:
February 15, 2021
Estimated Completion Date:
December 31, 2026

Study Description

PRIMARY OBJECTIVE:

I. Evaluate the safety of a progressive, home-based, tele-exercise resistance training (tele-RT) intervention in patients undergoing first line FOLFIRINOX chemotherapy for advanced pancreatic ductal adenocarcinoma (PDAC) (Study 1) and in survivors who have undergone pancreatic cancer resection (Study 2).

SECONDARY OBJECTIVES:

I. Evaluate the feasibility and acceptability of the tele-RT intervention.

II. Evaluate changes in the following exploratory outcome measures over the course of first-line FOLFIRINOX for advanced PDAC and associations between resistance training (RT) volumes and their changes:

IIa. Muscular strength IIb. Muscular endurance IIc. Body composition (skeletal muscle mass) IId. Aerobic fitness IIe. Self-reported physical activity IIf. Self-reported physical functioning IIg. Fatigue IIh. Peripheral neuropathy IIi. Health-related quality of life (QOL) IIj. Completion of intended chemotherapy dose (Among patients who are undergoing chemotherapy; all participants in Study 1 and some in Study 2) IIk. Exercise motivation IIl. Exercise self-efficacy IIm. Social support for exercise IIn. Reduction or change in FOLFIRINOX treatment plan III. Evaluate cancer care providers' (treating physicians and other clinical personnel) perspectives regarding the feasibility and acceptability of the tele-RT intervention for their patients.

OUTLINE:

STUDY 1: During the first 2-3 months of first line FOLFIRINOX chemotherapy, patients complete at least 4 tele-RT sessions over 30-45 minutes each, every 2 weeks. Patients receive handouts created by MD Anderson Cancer Center (MDACC) clinical dietitians including individualized recommendations for daily protein intake and information about healthy protein supplementation during chemotherapy. Patient may also attend a visit with a registered dietician (or delegate dietician) per standard of care, if they have renal insufficiency, special dietary needs, or difficulty adhering to protein recommendations.

STUDY 2: After standard of care surgical resection, patients complete at least 4 tele-RT sessions over 30-45 minutes each, every 2 weeks for 2-3 months. Patients receive handouts created by MDACC clinical dietitians including individualized recommendations for daily protein intake and information about healthy protein supplementation during chemotherapy. Patient may also attend a visit with a registered dietician (or delegate dietician) per standard of care, if they have renal insufficiency, special dietary needs, or difficulty adhering to protein recommendations.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • M D Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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