Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers

Not Applicable

Recruiting

• Conditions: Cancer; Malignant Neoplasm
• Interventions: Other: Bioelectrical impedance Analysis (BIA); Other: D3-Creatine Dilution (D3Cr); Other: 6-Minute Walk Test (6MWT); Other: Timed Up and Go (TUG); Other: 30-second Sit-to-Stand (STS); Other: Hand Grip Strength (GS); Other: PBTL p16 expression; Other: CT, MR and PET Imaging

• Registration Number: NCT05823740
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

The primary objective of this study is to evaluate the feasibility and acceptability of obtaining repeated measurements of lean muscle mass, physical function, and biological aging in children receiving active cancer therapy. The secondary objective is to evaluate the feasibility of using the D3-creatine dilution method (D3Cr) to measure skeletal muscle mass in children with cancer.

Assessments will be collected at diagnosis, once during active treatment, and end of treatment in coordination with routine imaging to monitor changes in study outcomes during active cancer treatment. Key sociodemographic, treatment and health-related factors will be abstracted from the medical record.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-10
• Study First Posted: 2023-04-21
• Study Start: 2023-05-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18
• Primary Completion: 2026-01-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Hand Grip Strength (GS)	Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
Single Arm	PBTL p16 expression	Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
Single Arm	6-Minute Walk Test (6MWT)	Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
Single Arm	D3-Creatine Dilution (D3Cr)	Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
Single Arm	Bioelectrical impedance Analysis (BIA)	Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
Single Arm	Timed Up and Go (TUG)	Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
Single Arm	30-second Sit-to-Stand (STS)	Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
Single Arm	CT, MR and PET Imaging	Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.

Primary Outcome Measures

Name	Time	Method
The feasibility of collecting body composition assessments	up to 12 months	The feasibility of collecting body composition assessments will be measured as the % of participants completing all 3 assessments for each modality: D3-Creatine dilution method (D3Cr), Bioelectrical impedance Analysis (BIA), medical imaging (computerized tomography (CT), or magnetic resonance imaging (MRI), or positron emission tomography (PET).
The feasibility of collecting individual physical function assessments	up to 12 months	The feasibility of collecting individual physical function assessments will be measured as the % of participants completing all 3 assessments for each modality namely the 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), 30-second Sit-to-Stand (STS), Hand Grip Strength (GS)) at multiple time points during cancer therapy.

Secondary Outcome Measures

Name	Time	Method
Feasibility of collecting repeated measurements of biological aging (p16 expression)	up to 12 months	The feasibility of collecting repeated measurements of biological aging (p16 expression) will be evaluated as % of participants completed both pre-treatment and post-treatment assessments.
The acceptability of the study	up to 12 months	The acceptability of the study will be evaluated as the number of subjects approached and enrolled and number of subjects that withdraw from the study.

Trial Locations

Locations (1)

UNC Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States