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

NCT04837118 | Active Not Recruiting

• 2 other identifiers: 2020-0147NCI-2021-02028
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Pancreatic Adenocarcinoma; Pancreatic Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8

Outcome Measures

Primary Outcomes (4)

• Safety of the tele-resistance training (RT) program

  Safety will be assessed based on the rate of musculoskeletal injuries and other adverse health events that participants incur while participating in tele-RT sessions. Participants will be monitored throughout the exercise intervention for musculoskeletal injuries and other adverse health events and referred to a Physical Medicine and Rehabilitation physician or their gastrointestinal (GI) Medical Oncology teams as necessary. The association of the injury with strength training will be assessed by asking participants to rate the injury on a scale of 1-4 (1=not related, 2=unlikely related, 3=likely related, 4=definitely related). The severity of the injury will be rated on a scale of 1-4 (1=mild/no change in daily activity, 2=some limitation of daily activity, 3=major limitation of daily activity, 4=life threatening). The duration for which daily activities were impacted will be rated on a scale from 1-5 (1=no change, 2=1-3 days, 3=4-7 days, 4=1-2 weeks, 5=more than 2 weeks).

  3-4 months

• Post-exercise muscle soreness

  Soreness will be assessed at the beginning of each tele-RT session, with participants asked to describe how soreness has changed since the previous RT session and how soreness has changed over the course of RT sessions. If soreness is not becoming more manageable with ongoing RT, participants will be referred to Dr. Ngo-Huang (study co-principal investigator \[PI\] and physiatrist) for follow-up to rule out any underlying injuries.

  3-4 months

• Body composition

  Cross-sectional areas (CSA) of skeletal muscle, intramuscular fat, visceral fat, and subcutaneous fat will be measured using SliceOMatic software (TomoVision, 2012) using computed tomography images routinely obtained for cancer assessment and staging purposes. Imaging dates will align with cancer staging and restaging appointments at T0 and T1. Cross-sectional areas at the L3 vertebral level will be standardized to the square of participants' heights in meters. Average radiodensity (in Hounsfield Units) of skeletal muscle will also be collected using SliceOMatic software.

  3-4 months

• Aerobic fitness

  Will be measured using 6-minute walk test (6MWT) distance, measured in meters. For participants who undergo remote exercise testing, the 2-minute step test will be used to assess aerobic fitness. Participants will be guided to step in place as quickly as possible, raising each knee to the proper height (midway between the opposite knee and hip), with trainers recording the number of complete steps they can complete in 2 minutes.

  3-4 months

Secondary Outcomes (15)

• Acceptability for Feasibility

  3-4 months

• Acceptability for participants

  3-4 months

• Acceptability for providers

  3-4 months

• Dynamic upper- and lower-body muscular strength

  3-4 months

• Dynamic upper- and lower-body muscular endurance

  3-4 months

Study Arms (1)

Supportive care (resistance training)

EXPERIMENTAL

SEE DETAILED DESCRIPTION.

Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Resistance Training

Interventions

Educational Intervention OTHER

Receive handouts containing dietary recommendations

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Supportive care (resistance training)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (resistance training)

Resistance Training OTHER

Participate in a resistance training program

Also known as: Strength Training

Supportive care (resistance training)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (resistance training)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-proven pancreatic adenocarcinoma, advanced stage (III-IV) (study 1) OR biopsy-proven pancreatic adenocarcinoma, at least 10 weeks post-surgical tumor resection and currently with no radiographic evidence of disease on recent computerized 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 MD Anderson Main Campus for restaging (study 1) OR plans to return to MDACC for restaging appointments in 3-4 months, including follow up CT scan (study 2)
• Able to schedule baseline (T0) appointment for fitness testing and program teaching at the Behavioral Research and Treatment Center (BRTC) or able to schedule remote fitness testing and program teaching
• Able to understand the description of the study, exercise program, and willing to participate
• Home access to wireless internet (Wi-Fi) and agreement to engage with study personnel 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 in participants' care and have some interaction with intervention personnel during recruitment, referral, scheduling, or follow up will be asked to complete questionnaires assessing intervention acceptability. The exact number of providers who will be asked to complete questionnaires will depend on whether patients enroll from the different GI Medical Oncology and GI Surgery clinics, but we expect 10-20 providers to be eligible

You may not qualify if:

• Non-English speaking
• Has participated in regular RT (RT for all major muscle groups at least twice per week) 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 Readiness Questionnaire (PAR-Q) and/or Patient Reported Outcomes Measurement Information System (PROMIS) questions
• 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
• FEMALES ONLY: Known pregnancy, as communicated to study personnel by clinicians in gastrointestinal (GI) Medical Oncology; females of childbearing potential receive advice to use methods of contraception per usual care

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Karen Basen-Engquist, BA,MPH,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 8, 2021
• Study Start: February 15, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)