Pancreatic CancerPhase 3NCT05836870
Tele-PancFit: A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer
A Phase 3 study testing Tele-supervised resistance exercises in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if a supervised exercise program during chemotherapy treatments can help to improve outcomes in patients who have been diagnosed with pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Tele-supervised resistance exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2023to 31 Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Biopsy-proven pancreatic adenocarcinoma, resectable/borderline resectable (T1-3, N0-2, M0)
- Recommended to receive 2-6 months of neoadjuvant chemotherapy followed by surgical resection including participants who have not yet received chemotherapy and participants who have already received their first cycle of chemotherapy.
- Willingness to adhere to the Tele-PancFit study intervention
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Show all 14Show fewer
- Able to schedule baseline (T0) appointment for fitness testing and program teaching at the fitness testing location at each study site or able to schedule remote fitness testing and program teaching:
- Behavioral Research and Treatment Center (BRTC) at MDACC
- Exercise Physiology laboratory in the Department of Kinesiology and Health Education at UT Austin
- Outpatient Rehabilitation gymnasium at Banner MDA
- Able to understand the description of the study, exercise program, and willing to participate
- Home or community 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 (described below).
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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 PAR-Q and/or PROMIS questions as described in section 4.4 (Screening Procedure).
- Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV).
Show all 10Show fewer
- 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 GI Medical Oncology; females of childbearing potential receive advice to use methods of contraception per usual care.
Trial locations and contacts
1 site in 1 country.
About this study
To learn if a supervised exercise program during chemotherapy treatments can help to improve outcomes in patients who have been diagnosed with pancreatic cancer
Read the detailed description
Primary Objectives:
Compare the rate of adjuvant chemotherapy initiation in patients who receive Tele-PancFit (telesupervised strengthening and remotely-monitored moderate intensity aerobic exercise) versus an enhanced usual care group who receive general recommendations for physical activity and receive an activity tracker.
Hypothesis: Tele-PancFit participation (Arm B) will improve the rate of adjuvant therapy compared to enhanced usual care (Arm A).
Secondary Objectives:
- Determine the effects of Tele-PancFit intervention on HRQOL among patients with localized PDAC, including the change of the HRQOL over time and the between study groups.
- Compare skeletal muscle maintenance indicated by SMI using CT between patients in the exercise and UC groups of the Tele-PancFit intervention.
- Define the effects of Tele-PancFit participation on tumor vascular density and maturity among patients undergoing neoadjuvant chemotherapy for PDAC. Other exploratory objectives include:
- Determine the effects of the Tele-PancFit intervention on secondary physical function, symptom and body composition study measures. Compare changes between baseline, preoperative and postoperative timepoints within each study arm and between study arms of the following measures. Also compare outcome values between study arms at each data collection timepoint.
- Skeletal muscle maintenance (skeletal muscle index [SMI] using routinely-obtained CT scans)
- Skeletal muscle quality (skeletal muscle density [SMD] using routinely-obtained CT scans)
- Visceral fat and subcutaneous fat using routinely-obtained CT scans
- Muscle strength (1-RM chest press,1-RM leg press, 30 second chair stand test and 30 second arm curl test)
- Muscle endurance
- Submaximal exercise capacity (6MWT)
- Self-reported exercise (Modified Godin)
- Self-reported physical functioning (PROMIS Cancer Function)
- Fatigue (FACIT-F)
- HRQOL (FACT-Hep)
- To compare levels of circulating tumor-associated and angiogenic factors such as CA 19-9, thrombospondin, CXCL12, IL-1b, VEGF, S1P between groups upon enrollment (T0), following administration of preoperative therapy (T1), and at postoperative visits (T2a/b).
- To compare cancer associated fibroblasts (CAFs), and tumor infiltrating immune cells between groups (among patients who have undergone surgical resection).
- Determine the effects of the Tele-PancFit intervention on oncology treatment outcomes by comparing these measures in the Arms A and B:
- Completion of intended NT dose
- Dose reduction or change in NT treatment plan
- Time of initiation of AT after surgery
- Dose reduction or change in AT treatment plan
- Completion of AT (6 months total perioperative chemotherapy)
- incidence of perioperative adverse events that occur within 90 days between groups (Accordion score)
- Hospital length of stay
- Acute cancer care center or emergency center visits within 30 days of surgery
- Evaluate the effects of adherence to nutritional recommendations to body composition and physical function. Evaluate the effects of weight loss and sarcopenia status (yes/no) on body composition.
- To assess the change in nutrition status (PGSGAsf) along all study time points in all enrolled participants. Also, to correlate the PGSGAsf score with the corresponding anthropometric measures at each time point for all participants.
- To examine differences among Fitbit-measured physical activity and sleep between groups and associations among Fitbit variables and secondary endpoints between and within groups.
- To compare the 6MWT distance and secondary endpoints of participants within subgroups of patients who are stratified as "active" versus "insufficiently active" based on the Godin-Shephard Leisure Time Physical Activity Questionnaire.
- To compare the 6MWT distance and secondary endpoints of participants within subgroups of patients with different levels of physical activity (light, moderate, high intensity activity).
- To explore the effect of sociodemographic variables (sex, age, race/ethnicity, zip code [for urban vs rural classification], distance form the hospital, marital status, insurance), need to borrow devices and Wi-Fi connection on patient clinical outcomes and adherence to the activity prescription.
- Conditions
- Pancreatic Cancer
- Being tested
- Enhanced Usual Care, Tele-supervised resistance exercises
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual CareOther
Participants will receive general recommendations to maintain physical activity.
Tele-supervised resistance exercisesBehavioural
Participants will take part in a monitored exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Group A-Enhanced Usual Care | Experimental | Participants will be given general recommendations to increase physical activity and improve nutrition before surgery. Receives: Other: Enhanced Usual Care |
| Group B-Tele-supervised resistance exercises | Experimental | Participants will take part in a monitored exercise program. The study team will provide more instructions and information about the program Receives: Behavioral: Tele-supervised resistance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: thorugh study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start18 Jul 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- An Ngo-Huang, DO, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836870
- Sponsor's protocol ID
- 2023-0033
- Other IDs
- NCI-2023-03448
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-PancFit: A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05836870
- Acronym / sponsor ID
- 2023-0033
- Conditions
- Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if a supervised exercise program during chemotherapy treatments can help to improve outcomes in patients who have been diagnosed with pancreatic cancer
Detailed description
Primary Objectives:
Compare the rate of adjuvant chemotherapy initiation in patients who receive Tele-PancFit (telesupervised strengthening and remotely-monitored moderate intensity aerobic exercise) versus an enhanced usual care group who receive general recommendations for physical activity and receive an activity tracker.
Hypothesis: Tele-PancFit participation (Arm B) will improve the rate of adjuvant therapy compared to enhanced usual care (Arm A).
Secondary Objectives:
- Determine the effects of Tele-PancFit intervention on HRQOL among patients with localized PDAC, including the change of the HRQOL over time and the between study groups.
- Compare skeletal muscle maintenance indicated by SMI using CT between patients in the exercise and UC groups of the Tele-PancFit intervention.
- Define the effects of Tele-PancFit participation on tumor vascular density and maturity among patients undergoing neoadjuvant chemotherapy for PDAC. Other exploratory objectives include:
- Determine the effects of the Tele-PancFit intervention on secondary physical function, symptom and body composition study measures. Compare changes between baseline, preoperative and postoperative timepoints within each study arm and between study arms of the following measures. Also compare outcome values between study arms at each data collection timepoint.
- Skeletal muscle maintenance (skeletal muscle index [SMI] using routinely-obtained CT scans)
- Skeletal muscle quality (skeletal muscle density [SMD] using routinely-obtained CT scans)
- Visceral fat and subcutaneous fat using routinely-obtained CT scans
- Muscle strength (1-RM chest press,1-RM leg press, 30 second chair stand test and 30 second arm curl test)
- Muscle endurance
- Submaximal exercise capacity (6MWT)
- Self-reported exercise (Modified Godin)
- Self-reported physical functioning (PROMIS Cancer Function)
- Fatigue (FACIT-F)
- HRQOL (FACT-Hep)
- To compare levels of circulating tumor-associated and angiogenic factors such as CA 19-9, thrombospondin, CXCL12, IL-1b, VEGF, S1P between groups upon enrollment (T0), following administration of preoperative therapy (T1), and at postoperative visits (T2a/b).
- To compare cancer associated fibroblasts (CAFs), and tumor infiltrating immune cells between groups (among patients who have undergone surgical resection).
- Determine the effects of the Tele-PancFit intervention on oncology treatment outcomes by comparing these measures in the Arms A and B:
- Completion of intended NT dose
- Dose reduction or change in NT treatment plan
- Time of initiation of AT after surgery
- Dose reduction or change in AT treatment plan
- Completion of AT (6 months total perioperative chemotherapy)
- incidence of perioperative adverse events that occur within 90 days between groups (Accordion score)
- Hospital length of stay
- Acute cancer care center or emergency center visits within 30 days of surgery
- Evaluate the effects of adherence to nutritional recommendations to body composition and physical function. Evaluate the effects of weight loss and sarcopenia status (yes/no) on body composition.
- To assess the change in nutrition status (PGSGAsf) along all study time points in all enrolled participants. Also, to correlate the PGSGAsf score with the corresponding anthropometric measures at each time point for all participants.
- To examine differences among Fitbit-measured physical activity and sleep between groups and associations among Fitbit variables and secondary endpoints between and within groups.
- To compare the 6MWT distance and secondary endpoints of participants within subgroups of patients who are stratified as "active" versus "insufficiently active" based on the Godin-Shephard Leisure Time Physical Activity Questionnaire.
- To compare the 6MWT distance and secondary endpoints of participants within subgroups of patients with different levels of physical activity (light, moderate, high intensity activity).
- To explore the effect of sociodemographic variables (sex, age, race/ethnicity, zip code [for urban vs rural classification], distance form the hospital, marital status, insurance), need to borrow devices and Wi-Fi connection on patient clinical outcomes and adherence to the activity prescription.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A-Enhanced Usual Care | Experimental | Other: Enhanced Usual CareParticipants will be given general recommendations to increase physical activity and improve nutrition before surgery. |
| Group B-Tele-supervised resistance exercises | Experimental | Behavioral: Tele-supervised resistance exercisesParticipants will take part in a monitored exercise program. The study team will provide more instructions and information about the program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Biopsy-proven pancreatic adenocarcinoma, resectable/borderline resectable (T1-3, N0-2, M0)
- Recommended to receive 2-6 months of neoadjuvant chemotherapy followed by surgical resection including participants who have not yet received chemotherapy and participants who have already received their first cycle of chemotherapy.
- Willingness to adhere to the Tele-PancFit study intervention
Key exclusion criteria (10 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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 PAR-Q and/or PROMIS questions as described in section 4.4 (Screening Procedure).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Usual CareParticipants will receive general recommendations to maintain physical activity. | Other | Group A-Enhanced Usual Care |
| Tele-supervised resistance exercisesParticipants will take part in a monitored exercise program. | Behavioural | Group B-Tele-supervised resistance exercises |
Primary outcome
Safety and adverse events (AEs)
Time frame: thorugh study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
An Ngo-Huang, DO principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tele-supervised resistance exercises in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: thorugh study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.