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

Pancreatic Cancer Clinical Trial

— INSPIRE  

Official title:

A Study of the Efficacy of Oral Nutritional Supplementation to Reduce Postoperative Complications Associated With Pancreatic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03244683
• Other study ID #: 2017H0170
• Status: Terminated
• Phase: N/A
• Start date: August 28, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: March 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatic Cancer
• Pancreatitis
• Pancreatitis, Chronic
• Postoperative Complications

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	The postoperative complication rate of 1 or more complication	30 days
Secondary	Supplement compliance	Frequency of subjects compliant with =70% of the provided preoperative supplement.	7-14 days
Secondary	Anthropometric measures	Serial anthropometric measures.	30 days
Secondary	Length of stay and readmission	Hospital length of stay and readmission rate	30 days