Spine and Tumor Screening and Supplementation

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03660540
• Other study ID #: 201805970
• Status: Withdrawn
• Phase: N/A
• Start date: January 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: February 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Nutritional Deficiency
• Sarcoma
• Spinal Injuries

Intervention

Dietary Supplement:
• Juven
Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	Orthopaedic Trauma Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	Change in muscle mass	One year
Secondary	Hand grip strength	Change in hand grip strength as measured by hand held dynamometer	One year
Secondary	Post-operative complications	Medical and surgical complications following operative fracture fixation, validated patient	One year