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

Primary Purpose

Pancreatic Cancer, Chronic Pancreatitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ensure Surgical
Nutrition counseling
Low-intensity exercise therapy
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

40 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intervention

Nutrition Counseling alone

Arm Description

Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling

Subjects randomized to this arm will receive: Dietary counseling along with standard of care procedures.

Outcomes

Primary Outcome Measures

Postoperative complications
The postoperative complication rate of 1 or more complication

Secondary Outcome Measures

Supplement compliance
Frequency of subjects compliant with ≥70% of the provided preoperative supplement.
Anthropometric measures
Serial anthropometric measures.
Length of stay and readmission
Hospital length of stay and readmission rate

Full Information

First Posted
August 7, 2017
Last Updated
March 2, 2021
Sponsor
Ohio State University
Collaborators
Abbott Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT03244683
Brief Title
A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery
Acronym
INSPIRE
Official Title
A Study of the Efficacy of Oral Nutritional Supplementation to Reduce Postoperative Complications Associated With Pancreatic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Closed due to low enrollment
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Abbott Nutrition

4. Oversight

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

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Chronic Pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling
Arm Title
Nutrition Counseling alone
Arm Type
Other
Arm Description
Subjects randomized to this arm will receive: Dietary counseling along with standard of care procedures.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure Surgical
Intervention Description
Subjects randomized to the intervention arm will consume two Ensure Surgical for 5-7 days.
Intervention Type
Other
Intervention Name(s)
Nutrition counseling
Intervention Description
All study subjects will be provided with nutrition counseling at the time of study enrollment.
Intervention Type
Other
Intervention Name(s)
Low-intensity exercise therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative complications
Description
The postoperative complication rate of 1 or more complication
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Supplement compliance
Description
Frequency of subjects compliant with ≥70% of the provided preoperative supplement.
Time Frame
7-14 days
Title
Anthropometric measures
Description
Serial anthropometric measures.
Time Frame
30 days
Title
Length of stay and readmission
Description
Hospital length of stay and readmission rate
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Hart, MD
Organizational Affiliation
The Ohio State University Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data to other researchers.

Learn more about this trial

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

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