A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery
Stopped early · Not applicable
Conditions studied: Pancreatic Cancer, Chronic Pancreatitis
In brief
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.
Key facts
- Study ID
- NCT03244683
- Run by
- Ohio State University
- People needed
- 8
- Starts
- 2017-08-28
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2021-03-04
Who can join
Age: 40 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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