Pancreatic Cancer, AdultNCT07478185
Prehab for Pancreatic Cancer Surgery
A study testing Multimodal Prehabilitation in people with Pancreatic Cancer, Adult and Prehabilitation, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The goal of this clinical study is to test whether a structured prehabilitation program can be successfully used by adults with pancreatic cancer who are receiving chemotherapy before planned surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Adult, Prehabilitation
- What is being tested?
- Multimodal Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to Dec 2028
- Phase
- Interventional
- 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
- Age ≥ 18 years
- Diagnosis of pancreatic ductal adenocarcinoma (PDAC)
- Planned neoadjuvant chemotherapy prior to planned surgical resection
- Medically stable and cleared to participate in physical activity/exercise programming
- Able to provide informed consent
- Ability to read, write and understand English
Who cannot join
- Age <18 years
- Pregnant
- Prisoner
- Severe cognitive impairment that precludes informed consent or participation
- Contraindications to physical activity, including unstable cardiac disease, severe pulmonary disease, or recent myocardial infarction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UMass Memorial Medical Center
Worester, Massachusetts, 01655
Kayla R Widdowson, MD, 774-641-1257, kayla.widdowson@umassmed.edu
About this study
Official title: Multimodal Prehabilitation Prior to Pancreatic Cancer Surgery: A Pilot Study
The goal of this clinical study is to test whether a structured prehabilitation program can be successfully used by adults with pancreatic cancer who are receiving chemotherapy before planned surgery. Prehabilitation is a program designed to improve a person's physical fitness, nutrition, and symptom control before surgery.
The study's main hypothesis is that patients with pancreatic cancer can take part in and adhere to a multimodal prehabilitation program during chemotherapy, and that doing so may improve physical function, patient experience, and early recovery after surgery.
Read the detailed description
This is a single-center, prospective pilot study designed to evaluate the implementation of a standardized, multimodal prehabilitation program delivered during neoadjuvant chemotherapy prior to pancreatic cancer surgery. The intervention is integrated into routine preoperative care and includes coordinated physical activity, nutritional optimization, and supportive care components delivered throughout the neoadjuvant treatment period. Assessments are performed at baseline, after completion of the prehabilitation period and before surgery, and approximately one month after surgery to characterize participation, intervention delivery, and perioperative changes in functional and clinical measures.
Data collection includes standardized functional fitness assessments, patient-reported surveys, and abstraction of perioperative clinical data from the electronic medical record. Analyses are descriptive and exploratory, reflecting the pilot nature of the study, and are intended to characterize feasibility, adherence, and variability of measured outcomes rather than to test efficacy. Findings from this study will be used to refine intervention delivery, identify logistical and patient-level barriers, and inform the design of future larger-scale studies evaluating prehabilitation in pancreatic cancer surgery.
- Conditions
- Pancreatic Cancer, Adult, Prehabilitation
- Being tested
- Multimodal Prehabilitation
- Keywords
- Prehabilitation, Nutritional status, Functional capacity, Pancreatic cancer, Pancreatectomy, Pancreaticoduodenectomy
- Medical subject headings
- Pancreatic cancer, adult, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal PrehabilitationBehavioural
Participants will receive a structured, multimodal prehabilitation program delivered during neoadjuvant chemotherapy prior to planned pancreatic cancer surgery. The program integrates supervised, individualized exercise training, nutritional assessment and counseling with recommended preoperative immunonutrition, and supportive care focused on symptom management and functional support. Prehabilitation is delivered as an integrated component of preoperative care and continues through completion of neoadjuvant therapy until surgery.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Prehabilitation Program | Experimental | Participants in this single-arm study will receive a structured prehabilitation program during neoadjuvant chemotherapy prior to planned pancreatic cancer surgery. Receives: Behavioral: Multimodal Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of prehabilitation program delivery
Feasibility will be assessed by the proportion of enrolled participants who initiate and complete the prehabilitation program during neoadjuvant chemotherapy prior to surgery.
Measured: From enrollment through completion of neoadjuvant therapy (approximately 3-6 months)
Adherence to prehabilitation components
Adherence will be measured by participant-reported completion of prescribed exercise sessions and reported completion of recommended preoperative immunonutrition.
Measured: From enrollment through preoperative assessment (approximately 3-6 months)
Secondary outcomes (8)
Change in 6-minute walk distance
Assessed using American Thoracic Society guidelines, change by difference in meters of walking distance achieved.
Measured: Baseline enrollment (pre-prehabilitation) to preoperative assessment (after completion of prehabilitation) up to 6 months after enrollment.
Change in Fried Frailty phenotype between enrollment and pre-operative evaluation
The Fried Frailty Phenotype is a five-component measure used to classify frailty status. Patients are evaluated for unintentional weight loss, weakness, slowness, poor endurance, and low physical activity (each criteria are assigned one point). A score of 0 is considered "not-frail," and a score of 1 or 2 is considered "prefrail" or at risk of frailty. A score of 3 or more meets the diagnosis of frail. The maximum possible score is 5 and higher scores indicate more frail.
Measured: Enrollment to preoperative assessment (up to 6 months after enrollment)
Change in nutritional status using the Patient Generated-Subjective Global Assessment (PG-SGA)
The PG-SGA SF consists of four boxes: box 1, questions regarding body weight (scored 0-5); box 2, food intake (score 0-4); box 3, symptoms affecting oral food intake (scored 0-23); and box 4, regarding activities and function (score 0-4). The sum of these four boxes can range from 0 to 36 points, with the higher the score, the greater the nutritional risk.
Measured: Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)
Change in body mass index (BMI)
Height in meters and weight in kilograms will be used to calculate BMI (kg/m^2).
Measured: Enrollment, preoperative assessment, through postoperative follow up, up to 1 year after enrollment
Change in physical functioning measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a
10-item questionnaire assessing current self-reported physical function. Raw scores are translated into T-scores, with a mean of 50 and a standard deviation of 10, for comparison with the U.S. general population mean. A higher T-score represents better physical function.
Measured: Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)
Change in health related quality of life measured by change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) score
FACT-Hep is a a 45-item self-report instrument designed to measure health-related quality of life (HRQL) in patients with hepatobiliary cancers. Scores range from 0-180 where higher scores indicate greater quality of life.
Measured: Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)
Postoperative complications measured using Clavien-Dindo classification
Clavien-Dindo classification is a standardized system used to grade postoperative complications based on the type of intervention required to manage the complication, rather than on the complication itself. Scores range from zero to five with higher scores indicating more severe. Highest severity complication according to Clavien-Dindo classification will be recorded.
Measured: Up to 30 days after surgery (up to 1 year after enrollment)
Postoperative hospital length of stay
Days from surgery to discharge will be recorded
Measured: Up to 90 days postoperative (up to 14 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start31 Mar 2026
- Primary completionFeb 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer, AdultStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Pancreatic Cancer Alliance
- Responsible party
- Principal investigator, James Lindberg, University of Massachusetts, Worcester
- Investigators
- James M Lindberg, MD, Principal investigator, UMass Memorial Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478185
- Sponsor's protocol ID
- STUDY00002524
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a pilot feasibility study, and no final determination has been made regarding sharing individual participant data. Decisions regarding data sharing will be informed by the size of the final dataset, privacy considerations, and the design of future confirmatory studies.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Prehabilitation Prior to Pancreatic Cancer Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT07478185
- Acronym / sponsor ID
- STUDY00002524
- Conditions
- Pancreatic Cancer, Adult, Prehabilitation
- Keywords
- Prehabilitation, Nutritional status, Functional capacity, Pancreatic cancer, Pancreatectomy, Pancreaticoduodenectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Pancreatic Cancer Alliance
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Mar 2026 (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.
The goal of this clinical study is to test whether a structured prehabilitation program can be successfully used by adults with pancreatic cancer who are receiving chemotherapy before planned surgery. Prehabilitation is a program designed to improve a person's physical fitness, nutrition, and symptom control before surgery.
The study's main hypothesis is that patients with pancreatic cancer can take part in and adhere to a multimodal prehabilitation program during chemotherapy, and that doing so may improve physical function, patient experience, and early recovery after surgery.
Detailed description
This is a single-center, prospective pilot study designed to evaluate the implementation of a standardized, multimodal prehabilitation program delivered during neoadjuvant chemotherapy prior to pancreatic cancer surgery. The intervention is integrated into routine preoperative care and includes coordinated physical activity, nutritional optimization, and supportive care components delivered throughout the neoadjuvant treatment period. Assessments are performed at baseline, after completion of the prehabilitation period and before surgery, and approximately one month after surgery to characterize participation, intervention delivery, and perioperative changes in functional and clinical measures.
Data collection includes standardized functional fitness assessments, patient-reported surveys, and abstraction of perioperative clinical data from the electronic medical record. Analyses are descriptive and exploratory, reflecting the pilot nature of the study, and are intended to characterize feasibility, adherence, and variability of measured outcomes rather than to test efficacy. Findings from this study will be used to refine intervention delivery, identify logistical and patient-level barriers, and inform the design of future larger-scale studies evaluating prehabilitation in pancreatic cancer surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Prehabilitation Program | Experimental | Behavioral: Multimodal PrehabilitationParticipants in this single-arm study will receive a structured prehabilitation program during neoadjuvant chemotherapy prior to planned pancreatic cancer surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Diagnosis of pancreatic ductal adenocarcinoma (PDAC)
- Planned neoadjuvant chemotherapy prior to planned surgical resection
- Medically stable and cleared to participate in physical activity/exercise programming
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Age <18 years
- Pregnant
- Prisoner
- Severe cognitive impairment that precludes informed consent or participation
- Contraindications to physical activity, including unstable cardiac disease, severe pulmonary disease, or recent myocardial infarction
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 |
|---|---|---|
| Multimodal PrehabilitationParticipants will receive a structured, multimodal prehabilitation program delivered during neoadjuvant chemotherapy prior to planned pancreatic cancer surgery. The program integrates supervised, individualized exercise training, nutritional assessment and counseling with recommended preoperative immunonutrition, and supportive care focused on symptom management and functional support. Prehabilitation is delivered as an integrated component of preoperative care and continues through completion of neoadjuvant therapy until surgery. | Behavioural | Multimodal Prehabilitation Program |
Primary outcome
Feasibility of prehabilitation program delivery
Time frame: From enrollment through completion of neoadjuvant therapy (approximately 3-6 months)
Feasibility will be assessed by the proportion of enrolled participants who initiate and complete the prehabilitation program during neoadjuvant chemotherapy prior to surgery.
Adherence to prehabilitation components
Time frame: From enrollment through preoperative assessment (approximately 3-6 months)
Adherence will be measured by participant-reported completion of prescribed exercise sessions and reported completion of recommended preoperative immunonutrition.
8 secondary outcomes
Change in 6-minute walk distance
Time frame: Baseline enrollment (pre-prehabilitation) to preoperative assessment (after completion of prehabilitation) up to 6 months after enrollment.
Change in Fried Frailty phenotype between enrollment and pre-operative evaluation
Time frame: Enrollment to preoperative assessment (up to 6 months after enrollment)
Change in nutritional status using the Patient Generated-Subjective Global Assessment (PG-SGA)
Time frame: Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)
Change in body mass index (BMI)
Time frame: Enrollment, preoperative assessment, through postoperative follow up, up to 1 year after enrollment
Change in physical functioning measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a
Time frame: Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)
Change in health related quality of life measured by change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) score
Time frame: Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)
Postoperative complications measured using Clavien-Dindo classification
Time frame: Up to 30 days after surgery (up to 1 year after enrollment)
Postoperative hospital length of stay
Time frame: Up to 90 days postoperative (up to 14 months after enrollment)
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 3 Apr 2026.
- Individual participant dataSharing planned: Undecided. This is a pilot feasibility study, and no final determination has been made regarding sharing individual participant data. Decisions regarding data sharing will be informed by the size of the final dataset, privacy considerations, and the design of future confirmatory studies.
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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.
James M Lindberg, MD principal investigator
UMass Memorial Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Prehabilitation in people with Pancreatic Cancer, Adult and Prehabilitation, run by University of Massachusetts, Worcester 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Apr 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?
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?
Contact Kayla R Widdowson, MD (774-641-1257, kayla.widdowson@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of prehabilitation program delivery (time frame: From enrollment through completion of neoadjuvant therapy (approximately 3-6 months)). The study lists 2 primary outcomes in all. 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 3 Apr 2026.