Spine and Tumor Screening and Supplementation

NCT03660540 | Withdrawn

• 1 other identifier: 201805970
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to evaluate an implementable screening tool and nutritional interventions that will lead to improved quality and patient safety. The aims of this pilot study are twofold: Purpose 1: assess the prognostic value of malnutrition and sarcopenia for identifying patients at increased risk of adverse postoperative outcomes following elective or semi-elective orthopedic procedures. Purpose 2: assess the clinical benefit of postoperative oral supplementation with a commercially-available nutritional supplement that includes conditionally-essential branched chain amino acids.

Conditions

Spinal Injuries; Sarcoma; Nutritional Deficiency

Outcome Measures

Primary Outcomes (1)

• Body composition

  Change in muscle mass

  One year

Secondary Outcomes (2)

• Hand grip strength

  One year

• Post-operative complications

  One year

Study Arms (2)

Nutritional supplement group

EXPERIMENTAL

Subjects in this group will be asked to consume the nutritional supplement on a daily basis, in addition to standard nutrition. Subjects will have pain medication and postoperative therapies per standard of care.

Dietary Supplement: Juven

Standard nutrition group

NO INTERVENTION

Subjects in this group will have standard nutrition provided per dietitian recommendation. Subjects will have pain medication and postoperative therapies per standard of care.

Interventions

Juven DIETARY_SUPPLEMENT

Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations.

Nutritional supplement group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Indicated for spinal or orthopedic oncology surgery

You may not qualify if:

• Unable to provide written consent
• Unable to comply with postoperative treatment recommendations
• Do not plan to follow up at the facility where surgery occurred
• Food allergy to ingredients in dietary supplement
• Intolerance to oral diet including phenylketonuria
• Pregnant women
• Individuals with dementia
• Vulnerable populations (minors, prisoners)
• Individuals lacking decision making capacity

Sponsors & Collaborators

• University of Iowa: lead
• Orthopaedic Trauma Association: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Spinal Injuries; Sarcoma; Malnutrition

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Nathan Hendrickson, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: January 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)