Pancreatic CancerNCT02648880
Preoperative Exercise in Pancreatic Cancer
A study testing Exercise program in people with Pancreatic Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of a preoperative exercise program in patients with pancreatic cancer preparing for surgery. Preoperative exercise programs have been shown to be effective in other cancer populations, but have not been investigated in patients with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2016to Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent (< 4 week) first diagnosis of a borderline resectable pancreatic adenocarcinoma
- Prescription to receive neoadjuvant therapy and surgery,
- Age 21 to 80 years old,
- Physician clearance to participate in exercise program.
Who cannot join
- Any significant comorbid conditions that would interfere with or preclude participation in an exercise intervention, including orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries
- Advanced rheumatoid arthritis
- Widespread chronic pain conditions such as fibromyalgia
- Pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, interstitial lung disease, use of supplementary oxygen
- Known cardiovascular disease or new cardiac event in last 6 months
- Diabetes
- Pregnancy
- Second cancer diagnosis at the time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Health and Wellness Center
Aurora, Colorado, 80045
About this study
Official title: The Effects of a Preoperative Exercise Intervention During Neoadjuvant Therapy in Patients With Pancreatic Cancer
The purpose of this study is to investigate the effects of a preoperative exercise program in patients with pancreatic cancer preparing for surgery. Preoperative exercise programs have been shown to be effective in other cancer populations, but have not been investigated in patients with pancreatic cancer. The outcomes in this study will be changes in physical fitness, function, and postoperative outcomes. This investigation is a non-randomized control trial, with participants assigned to receive the preoperative exercise intervention in addition to standard care, or standard care alone if unable to commit to an exercise program for practical reasons. Possible mediators for the effects of exercise on postoperative outcomes will also be assessed, including psychological outcomes and markers of systemic inflammation. These measures will be assessed in all participants prior to program initiation, prior to surgery, and after surgery. Changes in these measures in response to exercise will be assessed, as well as the ability of the preoperative measures to predict postoperative outcomes.
Read the detailed description
This study focuses on patients prescribed neoadjuvant (preoperative chemotherapy and radiation) prior to surgery for borderline resectable pancreatic adenocarcinoma. This allows for a known, preoperative window long enough to provide an effective exercise intervention. The exercise program will be administered for at least eight weeks, but has no cap on length, as neoadjuvent treatment periods can vary between participants and a cessation of the exercise program before the end of this period could result in an undesirable loss in physical fitness and function.
The study is a non-randomized, parallel group, intervention control trial, based on pilot studies in similar patient populations. All participants meeting the inclusion criteria and able to participate in the exercise program will be assigned to the exercise group. Participants meeting the inclusion criteria, but unable to commit to the exercise program for practical reasons (transportation, location, etc), will be assigned to the standard care group.
- Conditions
- Pancreatic Cancer
- Being tested
- Exercise program, Standard Care
- Keywords
- Exercise, Physical Activity
- Medical subject headings
- Pancreatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programBehavioural
Individual exercise sessions in this program implement a "whole body" approach and consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, resistance, and flexibility exercises. Target intensity of exercise will be based on the American College of Sports Medicine recommendations for cancer survivors. Prior to the start of exercise sessions, participants will be questioned on significant changes in symptoms or the presence of new symptoms (such as nausea or fever), which will used to modify the exercise session for that day to allow maximum symptom-limited participation.
Standard CareOther
The services that participants receive as standard care include their medical care, symptom control, social worker support, and nutrition. These services are provided by their oncology team.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Participants will complete an exercise program in addition to standard care. Participants will start the exercise program within four weeks of their diagnosis and decision to undergo neoadjuvant treatment and continue until surgery. Participants will be encouraged to complete three sessions per week for at least eight weeks during neoadjuvant therapy. Exercise intensity, components, and time will be recorded for each exercise session. Participants will schedule their sessions with the exercise specialists administering the program, typically taking place between 8AM and 4PM, Monday through Friday. Receives: Behavioral: Exercise program; Other: Standard Care |
| Standard Care | Active comparator | Participants in the Standard Care group will receive no exercise intervention, but will continue to receive standard follow-ups, treatments and services from their oncology team. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 400-meter Walk Time
Assessment of physical fitness and function. Participants are timed while walking 400 meters at a fast, but safe, pace.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Secondary outcomes (23)
Change in Body Composition
Assessment of physical fitness. Dual-energy x-ray absorptiometry (DXA) will assess lean muscle mass and body fat.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Gait Speed
Participant gait speed will be determined on a 10 meter course for both fast and self-selected paces.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Timed Up and Go
Participants are timed as they rise from a chair, walk 3 meters, turn around, and return to the chair and sit.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Stair Climb Test
Participants are timed as they ascend and descend one flight of stairs.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Single Limb Stance
Participants are timed on how long they can balance on one leg.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in 30 Second Sit-to-Stand
The number of times a participant can rise from a chair in 30 seconds is counted.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Grip Strength
The maximum force the participant can produce separately with both hands, assessed by grip dynamometry, is measured.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Average Daily Step Count
The average step count for a minimum of 3 days over a 7 day period will be assessed with accelerometry.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Wellness
The Colorado Comprehensive Wellness Assessment, a survey, will be administered to assess eight domains of wellness.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Health-related Quality of Life
The Functional Assessment of Cancer Therapy - General Form (FACT-G), a survey, will be administered.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Perceived Fatigue
Perceived fatigue will be assessed by the Revised Piper Fatigue Scale, a survey.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Anxiety
Changes in state and trait anxiety will be assessed with the Spielberger State-Trait Anxiety Index.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Perceived Stress
Changes in perceived stress will be assessed with the Perceived Stress Scale.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Resting Heart Rate Variability
Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Heart Rate Variability Response to Physiologic Challenge
Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period, and changes in response to a physiologic challenge (orthostatic stress: chair rise).
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Heart Rate Variability Response to Mental Stressor
Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period, and changes in response to a mental challenge (Stroop Task).
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Heart Rate Variability Response to a Cancer-specific Mental Stressor
Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period, and changes in response to a cancer-specific mental challenge (Cancer-Specific Stroop Task).
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in C-reactive Protein
Serum C-reactive protein will be assessed from blood draws.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Interleukin-6
Serum interleukin-6 will be assessed from blood draws.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Soluble Tumor-necrosis Factor Receptor 1
Soluble tumor-necrosis factor receptor 1 will be assessed from blood draws.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Interleukin-10
Serum interleukin-10 will be assessed from blood draws.
Measured: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Determination of Hospital Length of Stay
At 30 days after discharge from the hospital, a medical record review will be conducted to determine the number of days participants were in the hospital after surgery.
Measured: 30 days after hospital discharge
Determination of Hospital Readmission
At 30 days after discharge from the hospital, a medical record review will be conducted to determine whether participants were readmitted to the hospital for an unplanned surgical complication in the 30 days following hospital discharge.
Measured: 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start10 May 2016
- Primary completion20 Jan 2017
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Jankowski, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648880
- Sponsor's protocol ID
- 15-2266.cc
- Status last verified
- Nov 2021
- First submitted
- 29 Dec 2015
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: This is a small, non-FDA Regulated pilot study of an exercise intervention.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Preoperative Exercise Intervention During Neoadjuvant Therapy in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02648880
- Acronym / sponsor ID
- 15-2266.cc
- Conditions
- Pancreatic Cancer
- Keywords
- Exercise, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Posted 30 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of a preoperative exercise program in patients with pancreatic cancer preparing for surgery. Preoperative exercise programs have been shown to be effective in other cancer populations, but have not been investigated in patients with pancreatic cancer. The outcomes in this study will be changes in physical fitness, function, and postoperative outcomes. This investigation is a non-randomized control trial, with participants assigned to receive the preoperative exercise intervention in addition to standard care, or standard care alone if unable to commit to an exercise program for practical reasons. Possible mediators for the effects of exercise on postoperative outcomes will also be assessed, including psychological outcomes and markers of systemic inflammation. These measures will be assessed in all participants prior to program initiation, prior to surgery, and after surgery. Changes in these measures in response to exercise will be assessed, as well as the ability of the preoperative measures to predict postoperative outcomes.
Detailed description
This study focuses on patients prescribed neoadjuvant (preoperative chemotherapy and radiation) prior to surgery for borderline resectable pancreatic adenocarcinoma. This allows for a known, preoperative window long enough to provide an effective exercise intervention. The exercise program will be administered for at least eight weeks, but has no cap on length, as neoadjuvent treatment periods can vary between participants and a cessation of the exercise program before the end of this period could result in an undesirable loss in physical fitness and function.
The study is a non-randomized, parallel group, intervention control trial, based on pilot studies in similar patient populations. All participants meeting the inclusion criteria and able to participate in the exercise program will be assigned to the exercise group. Participants meeting the inclusion criteria, but unable to commit to the exercise program for practical reasons (transportation, location, etc), will be assigned to the standard care group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Exercise program, Other: Standard CareParticipants will complete an exercise program in addition to standard care. Participants will start the exercise program within four weeks of their diagnosis and decision to undergo neoadjuvant treatment and continue until surgery. Participants will be encouraged to complete three sessions per week for at least eight weeks during neoadjuvant therapy. Exercise intensity, components, and time will be recorded for each exercise session. Participants will schedule their sessions with the exercise specialists administering the program, typically taking place between 8AM and 4PM, Monday through Friday. |
| Standard Care | Active comparator | Other: Standard CareParticipants in the Standard Care group will receive no exercise intervention, but will continue to receive standard follow-ups, treatments and services from their oncology team. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recent (< 4 week) first diagnosis of a borderline resectable pancreatic adenocarcinoma
- Prescription to receive neoadjuvant therapy and surgery,
- Age 21 to 80 years old,
- Physician clearance to participate in exercise program.
Key exclusion criteria (8 listed)
- Any significant comorbid conditions that would interfere with or preclude participation in an exercise intervention, including orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries
- Advanced rheumatoid arthritis
- Widespread chronic pain conditions such as fibromyalgia
- Pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, interstitial lung disease, use of supplementary oxygen
- Known cardiovascular disease or new cardiac event in last 6 months
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 |
|---|---|---|
| Exercise programIndividual exercise sessions in this program implement a "whole body" approach and consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, resistance, and flexibility exercises. Target intensity of exercise will be based on the American College of Sports Medicine recommendations for cancer survivors. Prior to the start of exercise sessions, participants will be questioned on significant changes in symptoms or the presence of new symptoms (such as nausea or fever), which will used to modify the exercise session for that day to allow maximum symptom-limited participation. | Behavioural | Exercise Group |
| Standard CareThe services that participants receive as standard care include their medical care, symptom control, social worker support, and nutrition. These services are provided by their oncology team. | Other | Exercise Group, Standard Care |
Primary outcome
Change in 400-meter Walk Time
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Assessment of physical fitness and function. Participants are timed while walking 400 meters at a fast, but safe, pace.
23 secondary outcomes
Change in Body Composition
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Gait Speed
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Timed Up and Go
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Stair Climb Test
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Single Limb Stance
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in 30 Second Sit-to-Stand
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Grip Strength
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Average Daily Step Count
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Wellness
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Health-related Quality of Life
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Perceived Fatigue
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Anxiety
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Perceived Stress
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Resting Heart Rate Variability
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Heart Rate Variability Response to Physiologic Challenge
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Heart Rate Variability Response to Mental Stressor
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Heart Rate Variability Response to a Cancer-specific Mental Stressor
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in C-reactive Protein
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Interleukin-6
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Soluble Tumor-necrosis Factor Receptor 1
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Interleukin-10
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Determination of Hospital Length of Stay
Time frame: 30 days after hospital discharge
Determination of Hospital Readmission
Time frame: 30 days after hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. This is a small, non-FDA Regulated pilot study of an exercise intervention.
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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.
Catherine Jankowski, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program in people with Pancreatic Cancer, run by University of Colorado, Denver 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 30 Nov 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in 400-meter Walk Time (time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative). 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 30 Nov 2021.