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

Not Applicable

Terminated

• Conditions: Pancreatic Cancer; Chronic Pancreatitis
• Interventions: Other: Nutrition counseling; Dietary Supplement: Ensure Surgical; Other: Low-intensity exercise therapy

• Registration Number: NCT03244683
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-09
• Study Start: 2017-08-28
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition Counseling alone	Nutrition counseling	Subjects randomized to this arm will receive: Dietary counseling along with standard of care procedures.
Intervention	Low-intensity exercise therapy	Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling
Intervention	Ensure Surgical	Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling
Intervention	Nutrition counseling	Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling

Primary Outcome Measures

Name	Time	Method
Postoperative complications	30 days	The postoperative complication rate of 1 or more complication

Secondary Outcome Measures

Name	Time	Method
Supplement compliance	7-14 days	Frequency of subjects compliant with ≥70% of the provided preoperative supplement.
Anthropometric measures	30 days	Serial anthropometric measures.
Length of stay and readmission	30 days	Hospital length of stay and readmission rate

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States