Pancreatic CancerNCT03256201
Exercise and Nutrition to Improve Pancreatic Cancer Outcomes
A study testing Nutritional Counseling, Standard Exercise and Enhanced Exercise in people with Pancreatic Cancer, run by University of Oklahoma at 1 site in United States.
Trial summary
This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for pancreatic or related cancers are randomized to dietary counseling and home exercise at high weekly frequency, either with or without individualized resistance training, in order to determine if such an intervention and research… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Nutritional Counseling, Standard Exercise and Enhanced Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with suspected pancreatic or related tumor for surgical resection by pancreaticoduodenectomy, including those who've received neoadjuvant chemotherapy, are eligible provided they are approved for exercise participation by pancreatic clinic team.
- Cognition and English language skills must be sufficient for completion of consent and questionnaires.
- Age >30.
- Able to rise from a chair and walk household distances without assist from another person.
- Willing to be randomized to one of two pre-operative home-based exercise programs, without knowing the difference between the two, and use protein supplementation if instructed.
Who cannot join
- Individuals are excluded if they are unsafe (according to the study team) based on current MD recommendation not to exercise, medical history, recent fracture or high-risk bone lesion, or neurologic disorder with safety concerns.
- Participants cannot have an allergy to whey protein, or abnormal response to baseline physical performance tests of walking endurance and strength.
- Those who currently participate in a regular and substantial (as defined by the study team) strengthening or protein supplementation program are eligible only for the 'for assessment only' observational version of the study, but will not be included in the randomized trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Preoperative Exercise and Nutrition to Improve Pancreatic Cancer Outcomes by Targeting Sarcopenia: A Translational Pilot RCT
This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for pancreatic or related cancers are randomized to dietary counseling and home exercise at high weekly frequency, either with or without individualized resistance training, in order to determine if such an intervention and research design are feasible in this population. We also aim to determine if physical function or quality of life can be improved with only 2-3 weeks of prehabilitation. This is in preparation for a larger study to determine if resistance improves outcomes.
Read the detailed description
This initial feasibility and proof of concept study focuses on maximizing pancreatic cancer survivors' fitness and physical function in a brief period, the 2-3 weeks available prior to surgical resection, using a home-based exercise program with all equipment provided, and following nutritional recommendations. Intervention begins when the oncologist determines that the patient is a candidate for pancreaticoduodenectomy, and continues until surgery. Participants in both arms are asked to perform moderate exercise daily, targeting a total of 60 minutes per day by the surgery date, but in bouts as short as a few minutes each, and progressed according to tolerance. Initial prescription is individualized according to the patient's baseline level of exercise and functional status. Patients record their exercise and wear an accelerometer to track activity if willing. All participants receive follow-up phone calls from an exercise specialist for adherence and assistance with progression. The intervention period ends at the time of surgery.
In this 'quasi-double blinded' randomized trial, participants are not told the difference between the two exercise interventions, and randomization to the two treatment arms is stratified by baseline functional status, such that patients deemed to be 'borderline' in fitness for surgery are distributed across the groups. Prior chemotherapy exposure is allowed and recorded.
- Conditions
- Pancreatic Cancer
- Being tested
- Nutritional Counseling, Standard Exercise, Enhanced Exercise
- Keywords
- Cancer, prehabilitation, sarcopenia
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional CounselingBehavioural
Patients in both arms receive a single counseling session with a licensed dietician to determine individual protein goal for body weight and current dietary intake. Goal is then met through protein supplementation (provided) if needed beyond dietary intake.
Standard ExerciseBehavioural
Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.
Enhanced ExerciseBehavioural
Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.
| Study group | Role | What they receive |
|---|---|---|
| Standard Exercise Group | Experimental | Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs. Receives: Behavioral: Nutritional Counseling; Behavioral: Standard Exercise |
| Enhanced Exercise Group | Experimental | Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs. Receives: Behavioral: Nutritional Counseling; Behavioral: Enhanced Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual
The percentage of eligible patients enrolled
Measured: 2 year
Retention
Retention as the percentage of enrolled patients retained assessment point
Measured: 2 year
Adherence
Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls
Measured: 2 year
Secondary outcomes (9)
Quality of Life Assessment
Quality of life will be assessed using Functional Assessment of Cancer Therapy General Scale (FACT-G) during the pre-operative period (V1-V2). Scale is 0-108. The higher the score, the better the score.
Measured: Approximately 1-3 days pre-op
Change in Body Weight
Change in baseline body weight in pounds during the pre-operative period (V1-V2)
Measured: Approximately 1-3 days pre-op
Change in Body Weight
Change in baseline body weight in pounds at second post operative visit
Measured: Approximately 1-3 days pre-op
Physical Performance
Six-Minute Walk Test in meters during the pre-operative period (V1-V2). The Six Minute Walk test will be performed according to American Thoracic Society Guidelines.
Measured: Approximately 1-3 days pre-op
Physical Performance
Gait Speed at usual pace
Measured: Approximately 2-4 weeks pre-op
Physical Performance
Grip Strength . with a Jamar handgrip dynamometer .
Measured: Approximately 1-3 days pre-op
Physical Performance
Sit-to-Stand .Time to 5th Stand will be performed according to the Short Performance Physical Battery.
Measured: Approximately 4 months post-op
Assessment of Symptoms
Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep), at first post-operative visit.
Measured: Approximately 4 weeks post-op
Assessment of Symptoms
Functional Assessment of Anorexia-Cachexia Therapy - FAACT, during the pre-operative period (V1-V2).
Measured: Approximately 1-3 days pre-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start1 Feb 2016
- Primary completion1 Apr 2024
- Study completionMar 2025 (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 University of OklahomaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Hile, PhD, PT, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256201
- Sponsor's protocol ID
- 5991
- Status last verified
- Aug 2024
- First submitted
- 26 May 2017
- Last updated
- 16 Aug 2024
- Results posted
- No
- 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 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Exercise and Nutrition to Improve Pancreatic Cancer Outcomes by Targeting Sarcopenia: A Translational Pilot RCT
- ClinicalTrials.gov ID
- NCT03256201
- Acronym / sponsor ID
- 5991
- Conditions
- Pancreatic Cancer
- Keywords
- Cancer, prehabilitation, sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- Mar 2025 (estimated)
- First posted
- 21 Aug 2017 (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.
This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for pancreatic or related cancers are randomized to dietary counseling and home exercise at high weekly frequency, either with or without individualized resistance training, in order to determine if such an intervention and research design are feasible in this population. We also aim to determine if physical function or quality of life can be improved with only 2-3 weeks of prehabilitation. This is in preparation for a larger study to determine if resistance improves outcomes.
Detailed description
This initial feasibility and proof of concept study focuses on maximizing pancreatic cancer survivors' fitness and physical function in a brief period, the 2-3 weeks available prior to surgical resection, using a home-based exercise program with all equipment provided, and following nutritional recommendations. Intervention begins when the oncologist determines that the patient is a candidate for pancreaticoduodenectomy, and continues until surgery. Participants in both arms are asked to perform moderate exercise daily, targeting a total of 60 minutes per day by the surgery date, but in bouts as short as a few minutes each, and progressed according to tolerance. Initial prescription is individualized according to the patient's baseline level of exercise and functional status. Patients record their exercise and wear an accelerometer to track activity if willing. All participants receive follow-up phone calls from an exercise specialist for adherence and assistance with progression. The intervention period ends at the time of surgery.
In this 'quasi-double blinded' randomized trial, participants are not told the difference between the two exercise interventions, and randomization to the two treatment arms is stratified by baseline functional status, such that patients deemed to be 'borderline' in fitness for surgery are distributed across the groups. Prior chemotherapy exposure is allowed and recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Exercise Group | Experimental | Behavioral: Nutritional Counseling, Behavioral: Standard ExercisePatients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs. |
| Enhanced Exercise Group | Experimental | Behavioral: Nutritional Counseling, Behavioral: Enhanced ExercisePatients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals with suspected pancreatic or related tumor for surgical resection by pancreaticoduodenectomy, including those who've received neoadjuvant chemotherapy, are eligible provided they are approved for exercise participation by pancreatic clinic team.
- Cognition and English language skills must be sufficient for completion of consent and questionnaires.
- Age >30.
- Able to rise from a chair and walk household distances without assist from another person.
- Willing to be randomized to one of two pre-operative home-based exercise programs, without knowing the difference between the two, and use protein supplementation if instructed.
Key exclusion criteria (3 listed)
- Individuals are excluded if they are unsafe (according to the study team) based on current MD recommendation not to exercise, medical history, recent fracture or high-risk bone lesion, or neurologic disorder with safety concerns.
- Participants cannot have an allergy to whey protein, or abnormal response to baseline physical performance tests of walking endurance and strength.
- Those who currently participate in a regular and substantial (as defined by the study team) strengthening or protein supplementation program are eligible only for the 'for assessment only' observational version of the study, but will not be included in the randomized trial.
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 |
|---|---|---|
| Nutritional CounselingPatients in both arms receive a single counseling session with a licensed dietician to determine individual protein goal for body weight and current dietary intake. Goal is then met through protein supplementation (provided) if needed beyond dietary intake. | Behavioural | Enhanced Exercise Group, Standard Exercise Group |
| Standard ExercisePatients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs. | Behavioural | Standard Exercise Group |
| Enhanced ExercisePatients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs. | Behavioural | Enhanced Exercise Group |
Primary outcome
Accrual
Time frame: 2 year
The percentage of eligible patients enrolled
Retention
Time frame: 2 year
Retention as the percentage of enrolled patients retained assessment point
Adherence
Time frame: 2 year
Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls
9 secondary outcomes
Quality of Life Assessment
Time frame: Approximately 1-3 days pre-op
Change in Body Weight
Time frame: Approximately 1-3 days pre-op
Change in Body Weight
Time frame: Approximately 1-3 days pre-op
Physical Performance
Time frame: Approximately 1-3 days pre-op
Physical Performance
Time frame: Approximately 2-4 weeks pre-op
Physical Performance
Time frame: Approximately 1-3 days pre-op
Physical Performance
Time frame: Approximately 4 months post-op
Assessment of Symptoms
Time frame: Approximately 4 weeks post-op
Assessment of Symptoms
Time frame: Approximately 1-3 days pre-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- 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.
Elizabeth Hile, PhD, PT principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Counseling, Standard Exercise and Enhanced Exercise in people with Pancreatic Cancer, run by University of Oklahoma 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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?
Results are not available in the source record.
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?
Accrual (time frame: 2 year). The study lists 3 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 16 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.