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

Conditions:Cancer, Cancer, Hospital, Gastrointestinal, Gastrointestinal, Pancreatic Cancer
Therapuetic Areas:Gastroenterology, Oncology, Other
Age Range:40 - 89
Start Date:August 28, 2017
End Date:December 31, 2019
Contact:Karina Woodling

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

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.

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)

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.
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