Spine and Tumor Screening and Supplementation



Status:Not yet recruiting
Conditions:Cancer, Food Studies, Orthopedic
Therapuetic Areas:Oncology, Pharmacology / Toxicology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 100
Updated:1/12/2019
Start Date:April 2019
End Date:October 2020
Contact:Nathan Hendrickson, MD
Email:nathan-hendrickson@uiowa.edu
Phone:319-384-8452

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Improving Preoperative Screening and Postoperative Nutrition in Orthopedic Sarcoma and Spine Patients: Pilot Study

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.

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,

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
We found this trial at
1
site
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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