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

NCT03244683 | Terminated

• 1 other identifier: 2017H0170
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  The postoperative complication rate of 1 or more complication

  30 days

Secondary Outcomes (3)

• Supplement compliance

  7-14 days

• Anthropometric measures

  30 days

• Length of stay and readmission

  30 days

Study Arms (2)

Intervention

OTHER

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

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

Nutrition Counseling alone

OTHER

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

Other: Nutrition counseling

Interventions

Ensure Surgical DIETARY_SUPPLEMENT

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

Intervention

Nutrition counseling OTHER

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

Intervention; Nutrition Counseling alone

Low-intensity exercise therapy 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.

Intervention

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ohio State University: lead
• Abbott Nutrition: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip Hart, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 9, 2017
• Study Start: August 28, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)