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Spine and Tumor Screening and Supplementation

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ClinicalTrials.gov Identifier: NCT03660540
Recruitment Status : Not yet recruiting
First Posted : September 6, 2018
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Orthopaedic Trauma Association
Information provided by (Responsible Party):
Nathan Hendrickson, University of Iowa

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.


Condition or disease Intervention/treatment Phase
Spinal Injuries Sarcoma Nutritional Deficiency Dietary Supplement: Juven Not Applicable

Detailed Description:

All patients will be treated according to standard of care for their orthopedic injuries, including standard nutritional support in the preoperative period. Patients admitted to our academic Level I trauma center with spinal fractures and sarcoma requiring limb reconstruction will be approached for consent to participate in this study. Consented patients will be prospectively enrolled at the time of admission. We will obtain relevant patient medical history, standard preoperative labs, radiographic imaging, and nutritional assessment at the time of admission. Patients will be assessed for the presence of sarcopenia utilizing ultrasound measures of skeletal muscle as previously described.

All patients will be evaluated by a clinical dietitian or dietetic assistant for nutritional assessment as part of the standard of care. In addition to screening for sarcopenia and malnutrition, we will assess the clinical benefit of oral nutritional supplementation with essential branched-chain amino acids in a population of trauma patients. Patients providing written informed consent will be enrolled in a prospective RCT to assess nutritional supplementation with conditionally essential branched-chain amino acids. Patients will be randomly assigned to receive standard nutritional support or standard nutrition plus oral supplementation with a commercially available nutritional supplement containing essential branched chain amino acids (Juven, Abbot Nutrition). Similar combinations of essential amino acids have previously demonstrated protective effects against skeletal muscle wasting and medical complications in immobilized critically ill patients. Patients will be prospectively followed for 12 months from the time of admission to assess clinical outcomes. Our primary outcome measures include skeletal muscle mass changes, wound healing complications,


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Improving Preoperative Screening and Postoperative Nutrition in Orthopedic Sarcoma and Spine Patients: Pilot Study
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutritional supplement group
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
Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations.

No Intervention: Standard nutrition group
Subjects in this group will have standard nutrition provided per dietitian recommendation. Subjects will have pain medication and postoperative therapies per standard of care.



Primary Outcome Measures :
  1. Body composition [ Time Frame: One year ]
    Change in muscle mass


Secondary Outcome Measures :
  1. Hand grip strength [ Time Frame: One year ]
    Change in hand grip strength as measured by hand held dynamometer

  2. Post-operative complications [ Time Frame: One year ]
    Medical and surgical complications following operative fracture fixation, validated patient



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660540


Contacts
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Contact: Nathan Hendrickson, MD 319-384-8452 nathan-hendrickson@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Nathan Hendrickson
Orthopaedic Trauma Association
Investigators
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Principal Investigator: Nathan Hendrickson, MD University of Iowa

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Responsible Party: Nathan Hendrickson, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03660540     History of Changes
Other Study ID Numbers: 201805970
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sarcoma
Malnutrition
Spinal Injuries
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Nutrition Disorders
Back Injuries
Wounds and Injuries