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

NCT ID: NCT03244683

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-28
• Study Completion Date: 2018-08-01

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)

Conditions

Pancreatic Cancer; Chronic Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: OTHER

Ensure Surgical

Intervention Type: DIETARY_SUPPLEMENT

Subjects randomized to the intervention arm will consume two Ensure Surgical for 5-7 days.

Nutrition counseling

Intervention Type: OTHER

All study subjects will be provided with nutrition counseling at the time of study enrollment.

Low-intensity exercise therapy

Intervention Type: OTHER

Patients randomized to the intervention arm will also be provided with verbal and written instructions for light resistance training. The exercises will be performed at home during the preoperative study period.

Nutrition Counseling alone

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

Group Type: OTHER

Nutrition counseling

Intervention Type: OTHER

All study subjects will be provided with nutrition counseling at the time of study enrollment.

Interventions

Ensure Surgical

Subjects randomized to the intervention arm will consume two Ensure Surgical for 5-7 days.

Intervention Type: DIETARY_SUPPLEMENT

Nutrition counseling

All study subjects will be provided with nutrition counseling at the time of study enrollment.

Intervention Type: OTHER

Low-intensity exercise therapy

Patients randomized to the intervention arm will also be provided with verbal and written instructions for light resistance training. The exercises will be performed at home during the preoperative study period.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Philip Hart

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Hart, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2017H0170

Identifier Type: -

Identifier Source: org_study_id