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A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery (INSPIRE)

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ClinicalTrials.gov Identifier: NCT03244683
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
Abbott Nutrition
Information provided by (Responsible Party):
Philip Hart, Ohio State University

Brief 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 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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Chronic Pancreatitis Dietary Supplement: Ensure Surgical Other: Nutrition counseling Other: Low-intensity exercise therapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of the Efficacy of Oral Nutritional Supplementation to Reduce Postoperative Complications Associated With Pancreatic Surgery
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : June 27, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention
Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling
Dietary Supplement: Ensure Surgical
Subjects randomized to the intervention arm will consume two Ensure Surgical for 5-7 days.

Other: Nutrition counseling
All study subjects will be provided with nutrition counseling at the time of study enrollment.

Other: Low-intensity exercise therapy
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.

Nutrition Counseling alone
Subjects randomized to this arm will receive: Dietary counseling along with standard of care procedures.
Other: Nutrition counseling
All study subjects will be provided with nutrition counseling at the time of study enrollment.




Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days ]
    The postoperative complication rate of 1 or more complication


Secondary Outcome Measures :
  1. Supplement compliance [ Time Frame: 7-14 days ]
    Frequency of subjects compliant with ≥70% of the provided preoperative supplement.

  2. Anthropometric measures [ Time Frame: 30 days ]
    Serial anthropometric measures.

  3. Length of stay and readmission [ Time Frame: 30 days ]
    Hospital length of stay and readmission rate



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Ages Eligible for Study:   40 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 40-89 at the time of study enrollment.
  2. Undergoing pancreatectomy for either chronic pancreatitis or pancreatic cancer.
  3. Ability and willingness to complete study related documents and activities.

Exclusion Criteria:

  1. 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).
  2. Subject is receiving (or planned to receive) enteral tube feeding or parenteral nutrition at the time of screening or before surgery.
  3. Surgery is planned within 7 days of enrollment (i.e., inadequate time to offer the study intervention).
  4. Known allergy to soy or milk, which are included in the oral supplement.
  5. The inability to refrain from using a non-study oral nutritional supplement or fish oil supplementation (unless prescribed for treatment of hyperlipidemia).
  6. Pregnancy, incarceration, or inability to provide written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244683


Contacts
Contact: Karina Woodling 614-366-6703 Karina.Woodling@osumc.edu

Locations
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Karina M Woodling    614-366-6703    karina.woodling@osumc.edu   
Principal Investigator: Philip Hart, MD         
Sub-Investigator: David C Evans, MD         
Sponsors and Collaborators
Ohio State University
Abbott Nutrition
Investigators
Principal Investigator: Philip Hart, MD The Ohio State University Wexner Medical Center

Responsible Party: Philip Hart, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03244683     History of Changes
Other Study ID Numbers: 2017H0170
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pancreatitis, Chronic
Pancreatic Neoplasms
Pancreatitis
Postoperative Complications
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pathologic Processes