Pancreas CancerPREHABNCT05692323
A Supervised Prehabilitation Program for Patients With Pancreatic Cancer
A study testing PREHAB in people with Pancreas Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the use of an exercise program in people with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- PREHAB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 1 Apr 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pancreatic cancer diagnosis (any stage)
- Age ≥ 18 years
- Independent ambulation and activities of daily living (Discretion of referring/ treating oncologist)
- Godin-Shephard Leisure-Time Physical Activity Questionnaire score of ≤ 23
- Physically able to complete functional assessments including 6-minute walk test, hand grip strength, short performance physical battery and performance metrics
- Answers no to all questions on PAR-Q OR is cleared to participate by their treating oncologist
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- Ability to read, write and understand English
- Written informed consent obtained from subject and ability for subjects to comply with the requirements of the study
- Inclusion criteria for remote monitoring of physical activity (Fitbit) and online Pain portal only (failure to meet inclusion criterion below should not preclude subjects from participating in main study):
- Access to a smart device capable of Fitbit syncing and accessing the online Pain portal (www.painguide.com)
Who cannot join
- Has undergone or plans to undergo resection surgery prior to projected completion of PREHAB exercise intervention
- Current pregnancy
- Exclusion criteria for remote monitoring component of the study with Fitbit only (failure to meet exclusion criterion below should not preclude the subject from participating in main study):
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the PI deems study participation safe.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
The purpose of this study is to assess the use of an exercise program in people with pancreatic cancer.
Read the detailed description
Attendance to exercise sessions as well as impacts on healthcare utilization, muscle mass, quality of life, physical activity, and post-operative outcomes when applicable will be monitored.
Study participants will participant in a supervised, in-person exercise program 3 times per week for 6 weeks. Participants will receive a Fitbit to be worn continuously during the study and complete surveys and exercise tests at specified timepoints (Baseline, Post-Intervention Evaluation and 3-Month Follow Up).
- Conditions
- Pancreas Cancer
- Being tested
- PREHAB
- Keywords
- Exercise, Prehabilitation
- 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.
PREHABOther
6-week supervised PREHAB program. Each week of the program consists of 3 x 1 hour supervised training sessions made up of moderate intensity aerobic training and resistance training. In addition to the supervised sessions, patients will be instructed to accumulate a total of 150 minutes per week of moderate aerobic training at home which is measured by a wrist worn FitBit device.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Prehabilitation Exercise Program | Experimental | Not described Receives: Other: PREHAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
PREHAB Feasibility
PREHAB Program feasibility will be measured by tracking participant attendance at PREHAB sessions. PREHAB will be considered feasible if 50% of participants attend at least 60% of scheduled sessions. PREHAB session feasibility is defined as at least 50% of participants attending at least 60% of scheduled sessions
Measured: From Baseline to 3 Months
Secondary outcomes (1)
PREHAB Program Safety
PREHAB program safety will be evaluated by monitoring unanticipated problems involving risk to subjects or others (UPIRSO). PREHAB Program Safety will be assessed through the reporting of unanticipated problems from the baseline visit through to the 3 Month visit.
Measured: From Baseline to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start15 May 2023
- Primary completion15 Oct 2025
- Study completion1 Apr 2027 (estimated)
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 Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Chang, Cedars-Sinai Medical Center
- Investigators
- Philip Chang, DO, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692323
- Sponsor's protocol ID
- IIT2021-18-CHANG-PREHAB
- Acronym
- PREHAB
- Status last verified
- Aug 2026
- First submitted
- 11 Jan 2023
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Supervised Prehabilitation Program for Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05692323
- Acronym / sponsor ID
- PREHAB / IIT2021-18-CHANG-PREHAB
- Conditions
- Pancreas Cancer
- Keywords
- Exercise, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Posted 15 Apr 2026
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 assess the use of an exercise program in people with pancreatic cancer.
Detailed description
Attendance to exercise sessions as well as impacts on healthcare utilization, muscle mass, quality of life, physical activity, and post-operative outcomes when applicable will be monitored.
Study participants will participant in a supervised, in-person exercise program 3 times per week for 6 weeks. Participants will receive a Fitbit to be worn continuously during the study and complete surveys and exercise tests at specified timepoints (Baseline, Post-Intervention Evaluation and 3-Month Follow Up).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supervised Prehabilitation Exercise Program | Experimental | Other: PREHAB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pancreatic cancer diagnosis (any stage)
- Age ≥ 18 years
- Independent ambulation and activities of daily living (Discretion of referring/ treating oncologist)
- Godin-Shephard Leisure-Time Physical Activity Questionnaire score of ≤ 23
- Physically able to complete functional assessments including 6-minute walk test, hand grip strength, short performance physical battery and performance metrics
Key exclusion criteria (4 listed)
- Has undergone or plans to undergo resection surgery prior to projected completion of PREHAB exercise intervention
- Current pregnancy
- Exclusion criteria for remote monitoring component of the study with Fitbit only (failure to meet exclusion criterion below should not preclude the subject from participating in main study):
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the PI deems study participation safe.
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 |
|---|---|---|
| PREHAB6-week supervised PREHAB program. Each week of the program consists of 3 x 1 hour supervised training sessions made up of moderate intensity aerobic training and resistance training. In addition to the supervised sessions, patients will be instructed to accumulate a total of 150 minutes per week of moderate aerobic training at home which is measured by a wrist worn FitBit device. | Other | Supervised Prehabilitation Exercise Program |
Primary outcome
PREHAB Feasibility
Time frame: From Baseline to 3 Months
PREHAB Program feasibility will be measured by tracking participant attendance at PREHAB sessions. PREHAB will be considered feasible if 50% of participants attend at least 60% of scheduled sessions. PREHAB session feasibility is defined as at least 50% of participants attending at least 60% of scheduled sessions
1 secondary outcome
PREHAB Program Safety
Time frame: From Baseline to 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Philip Chang, DO principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREHAB in people with Pancreas Cancer, run by Cedars-Sinai Medical 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 10 inclusion and 4 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 19 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2026). 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?
PREHAB Feasibility (time frame: From Baseline to 3 Months). 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 19 Aug 2026.