Clinical trial NCT03244683: A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery
Official title: A Study of the Efficacy of Oral Nutritional Supplementation to Reduce Postoperative Complications Associated With Pancreatic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Cancer
Chronic Pancreatitis
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Abbott Nutrition
First posted: 2017-08-09
Enrollment: 8
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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.

Primary outcomes:
measure: Postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: Supplement compliance
timeFrame: 7-14 days
measure: Anthropometric measures
timeFrame: 30 days
measure: Length of stay and readmission
timeFrame: 30 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Philip Hart, MD
role: PRINCIPAL_INVESTIGATOR
References: