Pancreatic CancerINSPIRENCT03244683
A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery
A study testing Ensure Surgical, Nutrition counseling and Low-intensity exercise therapy in people with Pancreatic Cancer and Chronic Pancreatitis, run by Ohio State University at 1 site in United States.
Trial summary
This is a single center, open label, randomized trial, involving 150 patients undergoing pancreatic surgery. Patients will be randomized at the time of enrollment to receive from 5-7 days of ONS supplementation combined with resistance training and nutritional education compared to standard of care, consisting of… Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Pancreatic Cancer, Chronic Pancreatitis
- What is being tested?
- Ensure Surgical, Nutrition counseling and Low-intensity exercise therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 1 Aug 2018
- 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 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-89 at the time of study enrollment.
- Undergoing pancreatectomy for either chronic pancreatitis or pancreatic cancer.
- Ability and willingness to complete study related documents and activities.
Who cannot join
- Severe malnutrition that in the judgment of the patient's supervising physician or an investigator would not permit surgical intervention without preoperative nutritional support (enteral or parenteral).
- Subject is receiving (or planned to receive) enteral tube feeding or parenteral nutrition at the time of screening or before surgery.
- Surgery is planned within 7 days of enrollment (i.e., inadequate time to offer the study intervention).
- Known allergy to soy or milk, which are included in the oral supplement.
- The inability to refrain from using a non-study oral nutritional supplement or fish oil supplementation (unless prescribed for treatment of hyperlipidemia).
- Pregnancy, incarceration, or inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: A Study of the Efficacy of Oral Nutritional Supplementation to Reduce Postoperative Complications Associated With Pancreatic Surgery
This is a single center, open label, randomized trial, involving 150 patients undergoing pancreatic surgery. Patients will be randomized at the time of enrollment to receive from 5-7 days of ONS supplementation combined with resistance training and nutritional education compared to standard of care, consisting of nutritional education alone.
This proof of concept study is intended to demonstrate the ability of pre-habilitation to improve patient-related outcomes following pancreatic surgery, specifically postoperative complications. The rationale for using the designated oral nutrient supplementation is to preserve muscle mass, and decrease weight loss.
Read the detailed description
Patients undergoing pancreatic surgery for either chronic pancreatitis or known/suspected pancreatic cancer represent the study population for this clinical trial.
Study subjects randomized to one of the ONS arms will be asked to consume the drink during the study intervention. Study visits immediately preoperative, and 1, 3, and 6 months following surgery will be in-person visits. If subjects are unable to return to our Institution for subsequent clinical care, these telephone interviews will be collected and acquisition of locally obtained laboratory tests will be attempted.
Assessments performed during postoperative visits include:
- Vital signs and physical examination
- Blood samples
- Performance status and strength
- Quality of life measures
- Postoperative complications and hospital readmissions (if any)
- Conditions
- Pancreatic Cancer, Chronic Pancreatitis
- Being tested
- Ensure Surgical, Nutrition counseling, Low-intensity exercise therapy
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure SurgicalDietary supplement
Subjects randomized to the intervention arm will consume two Ensure Surgical for 5-7 days.
Nutrition counselingOther
All study subjects will be provided with nutrition counseling at the time of study enrollment.
Low-intensity exercise therapyOther
Patients randomized to the intervention arm will also be provided with verbal and written instructions for light resistance training. The exercises will be performed at home during the preoperative study period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling Receives: Dietary Supplement: Ensure Surgical; Other: Nutrition counseling; Other: Low-intensity exercise therapy |
| Nutrition Counseling alone | Other | Subjects randomized to this arm will receive: Dietary counseling along with standard of care procedures. Receives: Other: Nutrition counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
The postoperative complication rate of 1 or more complication
Measured: 30 days
Secondary outcomes (3)
Supplement compliance
Frequency of subjects compliant with ≥70% of the provided preoperative supplement.
Measured: 7-14 days
Anthropometric measures
Serial anthropometric measures.
Measured: 30 days
Length of stay and readmission
Hospital length of stay and readmission rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start28 Aug 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Why it stopped: Closed due to low enrollment
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 Ohio State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition
- Responsible party
- Principal investigator, Philip Hart, Ohio State University
- Investigators
- Philip Hart, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244683
- Sponsor's protocol ID
- 2017H0170
- Acronym
- INSPIRE
- Status last verified
- Mar 2021
- First submitted
- 7 Aug 2017
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy of Oral Nutritional Supplementation to Reduce Postoperative Complications Associated With Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT03244683
- Acronym / sponsor ID
- INSPIRE / 2017H0170
- Conditions
- Pancreatic Cancer, Chronic Pancreatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to low enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Abbott Nutrition
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 9 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 single center, open label, randomized trial, involving 150 patients undergoing pancreatic surgery. Patients will be randomized at the time of enrollment to receive from 5-7 days of ONS supplementation combined with resistance training and nutritional education compared to standard of care, consisting of nutritional education alone.
This proof of concept study is intended to demonstrate the ability of pre-habilitation to improve patient-related outcomes following pancreatic surgery, specifically postoperative complications. The rationale for using the designated oral nutrient supplementation is to preserve muscle mass, and decrease weight loss.
Detailed description
Patients undergoing pancreatic surgery for either chronic pancreatitis or known/suspected pancreatic cancer represent the study population for this clinical trial.
Study subjects randomized to one of the ONS arms will be asked to consume the drink during the study intervention. Study visits immediately preoperative, and 1, 3, and 6 months following surgery will be in-person visits. If subjects are unable to return to our Institution for subsequent clinical care, these telephone interviews will be collected and acquisition of locally obtained laboratory tests will be attempted.
Assessments performed during postoperative visits include:
- Vital signs and physical examination
- Blood samples
- Performance status and strength
- Quality of life measures
- Postoperative complications and hospital readmissions (if any)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Dietary Supplement: Ensure Surgical, Other: Nutrition counseling, Other: Low-intensity exercise therapySubjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling |
| Nutrition Counseling alone | Other | Other: Nutrition counselingSubjects randomized to this arm will receive: Dietary counseling along with standard of care procedures. |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40-89 at the time of study enrollment.
- Undergoing pancreatectomy for either chronic pancreatitis or pancreatic cancer.
- Ability and willingness to complete study related documents and activities.
Key exclusion criteria (6 listed)
- Severe malnutrition that in the judgment of the patient's supervising physician or an investigator would not permit surgical intervention without preoperative nutritional support (enteral or parenteral).
- Subject is receiving (or planned to receive) enteral tube feeding or parenteral nutrition at the time of screening or before surgery.
- Surgery is planned within 7 days of enrollment (i.e., inadequate time to offer the study intervention).
- Known allergy to soy or milk, which are included in the oral supplement.
- The inability to refrain from using a non-study oral nutritional supplement or fish oil supplementation (unless prescribed for treatment of hyperlipidemia).
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 |
|---|---|---|
| Ensure SurgicalSubjects randomized to the intervention arm will consume two Ensure Surgical for 5-7 days. | Dietary supplement | Intervention |
| Nutrition counselingAll study subjects will be provided with nutrition counseling at the time of study enrollment. | Other | Intervention, Nutrition Counseling alone |
| Low-intensity exercise therapyPatients randomized to the intervention arm will also be provided with verbal and written instructions for light resistance training. The exercises will be performed at home during the preoperative study period. | Other | Intervention |
Primary outcome
Postoperative complications
Time frame: 30 days
The postoperative complication rate of 1 or more complication
3 secondary outcomes
Supplement compliance
Time frame: 7-14 days
Anthropometric measures
Time frame: 30 days
Length of stay and readmission
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Closed due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data to other researchers.
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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 Hart, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure Surgical, Nutrition counseling and Low-intensity exercise therapy in people with Pancreatic Cancer and Chronic Pancreatitis, run by Ohio State University 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 4 Mar 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?
The study was stopped early (reason given: Closed due to low enrollment). 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?
Postoperative complications (time frame: 30 days). 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 4 Mar 2021.