Spine and Tumor Screening and Supplementation
Primary Purpose
Spinal Injuries, Sarcoma, Nutritional Deficiency
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Juven
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Injuries
Eligibility 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
Sites / Locations
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutritional supplement group
Standard nutrition group
Arm 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.
Subjects in this group will have standard nutrition provided per dietitian recommendation. Subjects will have pain medication and postoperative therapies per standard of care.
Outcomes
Primary Outcome Measures
Body composition
Change in muscle mass
Secondary Outcome Measures
Hand grip strength
Change in hand grip strength as measured by hand held dynamometer
Post-operative complications
Medical and surgical complications following operative fracture fixation, validated patient
Full Information
NCT ID
NCT03660540
First Posted
September 4, 2018
Last Updated
February 15, 2023
Sponsor
University of Iowa
Collaborators
Orthopaedic Trauma Association
1. Study Identification
Unique Protocol Identification Number
NCT03660540
Brief Title
Spine and Tumor Screening and Supplementation
Official Title
Improving Preoperative Screening and Postoperative Nutrition in Orthopedic Sarcoma and Spine Patients: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No enrollment
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Iowa
Collaborators
Orthopaedic Trauma Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Injuries, Sarcoma, Nutritional Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional supplement group
Arm Type
Experimental
Arm 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.
Arm Title
Standard nutrition group
Arm Type
No Intervention
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Juven
Intervention Description
Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations.
Primary Outcome Measure Information:
Title
Body composition
Description
Change in muscle mass
Time Frame
One year
Secondary Outcome Measure Information:
Title
Hand grip strength
Description
Change in hand grip strength as measured by hand held dynamometer
Time Frame
One year
Title
Post-operative complications
Description
Medical and surgical complications following operative fracture fixation, validated patient
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Hendrickson, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Spine and Tumor Screening and Supplementation
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