Spine and Tumor Screening and Supplementation

University of Iowa

Status: Withdrawn

Conditions: Sarcoma; Spinal Injuries; Nutritional Deficiency

Treatments: Dietary Supplement: Juven

Study type: Interventional

Funder types: Other

Identifiers

NCT03660540

201805970

Details and patient eligibility

About

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.

Full 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,

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Nutritional supplement group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Juven

Standard nutrition group

No Intervention group

Description:

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