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

The Ohio State University

Status: Terminated

Conditions: Chronic Pancreatitis; Pancreatic Cancer

Treatments: Other: Nutrition counseling; Dietary Supplement: Ensure Surgical; Other: Low-intensity exercise therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03244683

2017H0170

Details and patient eligibility

About

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.

Full 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)

Enrollment: 8 patients

Sex: All

Ages: 40 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Intervention

Other group

Description:

Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling

Treatment:

Other: Nutrition counseling

Dietary Supplement: Ensure Surgical

Other: Low-intensity exercise therapy

Nutrition Counseling alone

Other group

Description:

Subjects randomized to this arm will receive: Dietary counseling along with standard of care procedures.

Treatment:

Other: Nutrition counseling