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Trial Title:
Tele-PancFit: A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer
NCT ID:
NCT05836870
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Enhanced Usual Care
Description:
Participants will receive general recommendations to maintain physical activity.
Arm group label:
Group A-Enhanced Usual Care
Intervention type:
Behavioral
Intervention name:
Tele-supervised resistance exercises
Description:
Participants will take part in a monitored exercise program.
Arm group label:
Group B-Tele-supervised resistance exercises
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
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:
1. 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.
2. Compare skeletal muscle maintenance indicated by SMI using CT between patients in
the exercise and UC groups of the Tele-PancFit intervention.
3. Define the effects of Tele-PancFit participation on tumor vascular density and
maturity among patients undergoing neoadjuvant chemotherapy for PDAC.
Other exploratory objectives include:
4. 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.
1. Skeletal muscle maintenance (skeletal muscle index [SMI] using
routinely-obtained CT scans)
2. Skeletal muscle quality (skeletal muscle density [SMD] using routinely-obtained
CT scans)
3. Visceral fat and subcutaneous fat using routinely-obtained CT scans
4. Muscle strength (1-RM chest press,1-RM leg press, 30 second chair stand test
and 30 second arm curl test)
5. Muscle endurance
6. Submaximal exercise capacity (6MWT)
7. Self-reported exercise (Modified Godin)
8. Self-reported physical functioning (PROMIS Cancer Function)
9. Fatigue (FACIT-F)
10. HRQOL (FACT-Hep)
5. 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).
6. To compare cancer associated fibroblasts (CAFs), and tumor infiltrating immune cells
between groups (among patients who have undergone surgical resection).
7. Determine the effects of the Tele-PancFit intervention on oncology treatment
outcomes by comparing these measures in the Arms A and B:
1. Completion of intended NT dose
2. Dose reduction or change in NT treatment plan
3. Time of initiation of AT after surgery
4. Dose reduction or change in AT treatment plan
5. Completion of AT (6 months total perioperative chemotherapy)
6. incidence of perioperative adverse events that occur within 90 days between
groups (Accordion score)
7. Hospital length of stay
8. Acute cancer care center or emergency center visits within 30 days of surgery
8. 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.
9. 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.
10. To examine differences among Fitbit-measured physical activity and sleep between
groups and associations among Fitbit variables and secondary endpoints between and
within groups.
11. 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.
12. 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).
13. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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
- 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:
1. Behavioral Research and Treatment Center (BRTC) at MDACC
2. Exercise Physiology laboratory in the Department of Kinesiology and Health
Education at UT Austin
3. 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).
Exclusion criteria:
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).
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
An Ngo-Huang, DO
Phone:
713-745-2327
Email:
ango2@mdanderson.org
Investigator:
Last name:
An Ngo-Huang, DO
Email:
Principal Investigator
Start date:
July 18, 2023
Completion date:
December 31, 2032
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05836870
http://www.mdanderson.org
