Clinical trial · Interventional
Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 30-second Sit-to-Stand (STS) | Other | — | UNRESOLVED |
| 6-Minute Walk Test (6MWT) | Other | — | UNRESOLVED |
| Bioelectrical impedance Analysis (BIA) | Other | — | UNRESOLVED |
| CT, MR and PET Imaging | Other | — | UNRESOLVED |
| D3-Creatine Dilution (D3Cr) | Other | — | UNRESOLVED |
| Hand Grip Strength (GS) | Other | — | UNRESOLVED |
| PBTL p16 expression | Other | — | UNRESOLVED |
| Timed Up and Go (TUG) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm
- description
- Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
- interventionNames
- 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
Primary outcomes (2)
- measure
- The feasibility of collecting body composition assessments
- timeFrame
- up to 12 months
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below. 1. Ages 8-21 years at the time of cancer diagnosis 2. Must have a newly diagnosed malignant solid tumor or lymphoma. 3. Participant is expected to undergo cancer treatment with either chemotherapy, radiation, immunotherapy, or other biologically targeted therapy. 4. Participants will undergo routine imaging with either computed tomography (CT), or Magnetic Resonance Imaging (MRI) of the chest or abdomen, or whole-body positron emission tomography (PET) scan. 5. Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information. 6. English or Spanish speaking 7. Subject is willing and able to comply with study procedures. 8. Since the patient is undergoing active cancer therapy, must obtain approval from the treating physician. Exclusion Criteria All subjects meeting any exclusion criteria at baseline will be excluded from study participation. 1. Prior history of cancer 2. Treatment with surgical excision alone 3. Planned palliative treatment. 4. Subject has elected to forgo chemotherapy or radiotherapy. 5. Any diagnosis of leukemia. 6. Clinical concerns that the treating clinician feels would preclude participation in the study. 7. Subject has a pacemaker or bilateral joint prosthesis that would prevent undergoing BIA assessment. 8. Unwilling to sign informed consent. 9. Speak a language other than English or Spanish.
References
Publications (0)
Data not yet available