Body Composition and Physical Function Assessment for Childhood Cancer

Overseen By Daniel Kleissler

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Leukemia, Prior cancer, Palliative, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with your treating physician, as their approval is required for participation.

What data supports the effectiveness of the treatment 30-second Sit-to-Stand (STS) and 6-Minute Walk Test (6MWT) for assessing physical function in children with cancer?

Research suggests that the 30-second Sit-to-Stand test and the 6-Minute Walk Test are useful for measuring functional exercise capacity in children with various conditions, similar to how they might be used in children with cancer to assess physical function and performance. ^{1 2 3 4 5}

Is the 30-second Sit-to-Stand (STS) test safe for assessing physical performance?

The chair stand test, similar to the 30-second Sit-to-Stand (STS) test, is considered safe for assessing mobility and frailty in older adults, providing valuable information on physical performance. ^{1 6 7 8 9}

How does this treatment for childhood cancer differ from other treatments?

This treatment is unique because it focuses on assessing body composition and physical function, which are often overlooked in traditional cancer treatments. It aims to systematically evaluate physical performance aspects like cardiorespiratory fitness, muscle strength, and flexibility, which are crucial for improving the quality of life in pediatric cancer patients. ^{1 5 10 11 12}

Research Team

Andrew Smitherman

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

This trial is for children aged 8-21 with newly diagnosed malignant solid tumors or lymphoma, who are undergoing cancer treatment and can consent in English or Spanish. They must be approved by their treating physician to participate and able to undergo routine imaging like CT, MRI, or PET scans. It's not for those with a history of cancer treated only by surgery, planning palliative care, opting out of chemo/radiotherapy, diagnosed with leukemia, unable to consent, speaking other languages than English/Spanish or having conditions that prevent BIA assessment.

Inclusion Criteria

I have been recently diagnosed with cancer in either my solid organs or lymph nodes.

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

I was diagnosed with cancer between the ages of 8 and 21.

Exclusion Criteria

Unwilling to sign informed consent

I have had cancer before.

I have only had surgery to remove my condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnosis

Assessments collected at diagnosis to establish baseline measurements

1-2 weeks

1 visit (in-person)

Active Treatment

Participants receive active cancer therapy with repeated measurements of lean muscle mass, physical function, and biological aging

up to 12 months

Multiple visits (in-person) in coordination with routine imaging

End of Treatment

Final assessments collected to monitor changes in study outcomes

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

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

Trial Overview The study measures lean muscle mass changes using Bioelectrical Impedance Analysis (BIA), D3-Creatine Dilution (D3Cr) method; physical function through tests like the 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), Sit-to-Stand test; grip strength; biological aging via PBTL p16 expression; alongside routine imaging during active cancer therapy.

Participant Groups

Group I: Single Arm Experimental Treatment 8 Interventions

Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Findings from Research

A systematic review of 149 studies involving 11,639 pediatric cancer patients identified 63 different assessments for evaluating physical performance, with a focus on cardiorespiratory fitness and muscle strength, primarily in patients off treatment.

The review highlights significant gaps in research, particularly for certain outcomes like speed and specific cancer diagnoses such as neuroblastoma, indicating a need for more targeted assessments in these underrepresented areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and functional performance assessment in pediatric oncology: a systematic review. Söntgerath, R., Däggelmann, J., Kesting, SV., et al.[2023]

The 30-second sit-to-stand test (30s-STST) is a valid alternative to the six-minute walk test (6MWT) for measuring functional exercise capacity in children with bronchiectasis, explaining 52% of the variance in 6MWT results for this group.

Both tests showed similar ability to distinguish between children with bronchiectasis and healthy controls, with 30s-STST having a slightly better area under the ROC curve (0.765) compared to 6MWT (0.693), indicating they are equally effective in assessing exercise capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sit-to-stand test in children with bronchiectasis: Does it measure functional exercise capacity? Zeren, M., Gurses, HN., Denizoglu Kulli, H., et al.[2021]

This study analyzed grip strength and sit-to-stand test performance in 2301 adults aged 18-80, providing age- and sex-specific normative data that can help identify muscle weakness and probable sarcopenia.

Peak grip strength was found at around 34 years for women and 38 years for men, while performance on sit-to-stand tests was highest at age 18, indicating that muscle strength declines with age and can be assessed using the provided centile curves for rehabilitation purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex- and Age-Specific Centile Curves and Downloadable Calculator for Clinical Muscle Strength Tests to Identify Probable Sarcopenia. Warden, SJ., Liu, Z., Moe, SM.[2022]

A study involving 82 children and youths with cerebral palsy showed high agreement in performance on the six-minute walk test (6MWT) between 15m and 30m courses, with an intraclass correlation coefficient of 0.93, indicating reliable results.

The total walking distance was significantly longer in the 30m course (median 399m) compared to the 15m course (median 357m), suggesting that while both distances are valid for measuring endurance, consistency in distance is important for tracking individual progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the six-minute walk test performed over a 15 and 30 m course by children with cerebral palsy. Krasny, J., Jozwiak, M., Rodby-Bousquet, E.[2023]

A systematic review identified 101 physical function measures used in 154 studies for children with cancer, but only 12 measures had available measurement property data, indicating a lack of robust tools for assessing physical function in this population.

Despite some positive findings, no assessment tool was consistently recommended due to poor methodological quality in the studies, highlighting the need for further research to establish reliable and valid measures for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of physical function in children with cancer: A systematic review. Grimshaw, SL., Taylor, NF., Mechinaud, F., et al.[2019]

In a study of 520 COPD patients and 150 controls, the Timed Up and Go (TUG) test effectively identified impaired physical performance in COPD patients compared to controls, highlighting its potential for clinical use.

The TUG test showed a strong inverse relationship with the 6-minute walk distance (6MWD), indicating that as TUG times increased, walking distance decreased, which suggests it could be a reliable indicator of physical performance in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple and rapid test of physical performance inchronic obstructive pulmonary disease. Albarrati, AM., Gale, NS., Enright, S., et al.[2022]

The study involved 102 older adults and demonstrated that the five times sit-to-stand test (5×STS) using wearable sensors can effectively identify physical frailty (PF) and its key phenotypes (slowness, weakness, exhaustion) with high accuracy, as indicated by area under curve values ranging from 0.720 to 0.865.

Sensor-derived metrics from the 5×STS showed strong correlations with traditional manual measurements, suggesting that this method is not only safe and easy to administer but also suitable for remote assessments via telemedicine, making it a valuable tool for monitoring frailty in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Remote Assessment of Physical Frailty Using Sensor-based Sit-to-stand Test. Park, C., Sharafkhaneh, A., Bryant, MS., et al.[2022]

In a study of 113 women aged 85 and older, a significant decline in mobility was observed over 9 years, with average Timed Up and Go (TUG) scores increasing from 6.7 seconds to 13.2 seconds, indicating a notable decrease in mobility.

Key predictors of poorer mobility at follow-up included higher age, higher BMI, and poorer balance and step-climbing ability, suggesting that improving strength and balance through targeted exercise programs could help reduce the risk of mobility decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of mobility in community-dwelling women aged 85 and older. Idland, G., Rydwik, E., Småstuen, MC., et al.[2013]

A review of 23 studies on chair stand tests for older adults suggests that a protocol involving five chair stands performed at a fast pace is the most common and effective method for assessing mobility.

The proposed chair stand test protocol is feasible and safe, allowing clinicians to identify frailty levels in older adults and compare results across different studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the optimal chair stand test protocol for older adults? A systematic review. Mehmet, H., Yang, AWH., Robinson, SR.[2021]

Physical activity (PA) in adolescents and young adults with cancer is mainly assessed through self-reported questionnaires, with 30 out of 34 studies using this method, highlighting the reliance on subjective measures for tracking activity levels.

The review found significant variability in assessment methodologies across studies, which limits the ability to create standardized recommendations for researchers and healthcare providers regarding PA and physical fitness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and physical fitness assessments in adolescents and young adults diagnosed with cancer: a scoping review. Caru, M., Wurz, A., Brunet, J., et al.[2023]

The Juvenile Arthritis Functionality Scale (JAFS) is a newly developed 15-item questionnaire that effectively measures physical function in children with juvenile idiopathic arthritis (JIA), validated through a study of 211 patients aged 2.2 to 18 years.

The JAFS demonstrated strong reliability and construct validity, outperforming the Childhood Health Assessment Questionnaire (C-HAQ) in some areas, making it a promising tool for assessing physical function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a new short and simple measure of physical function for juvenile idiopathic arthritis. Filocamo, G., Sztajnbok, F., Cespedes-Cruz, A., et al.[2019]

The six-minute walk test (6MWT) is a practical and safe method to assess exercise capacity in children and adolescents, with age being the strongest predictor of distance walked, especially in younger participants.

In addition to age, factors like heart rate after the test, height, and weight significantly influence the distance walked, particularly in adolescents, highlighting the need for tailored reference values for different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reference values for the 6-minute walk test in healthy children and adolescents in Switzerland. Ulrich, S., Hildenbrand, FF., Treder, U., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Physical and functional performance assessment in pediatric oncology: a systematic review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Sit-to-stand test in children with bronchiectasis: Does it measure functional exercise capacity? [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Sex- and Age-Specific Centile Curves and Downloadable Calculator for Clinical Muscle Strength Tests to Identify Probable Sarcopenia. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Comparison of the six-minute walk test performed over a 15 and 30 m course by children with cerebral palsy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Assessment of physical function in children with cancer: A systematic review. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

A simple and rapid test of physical performance inchronic obstructive pulmonary disease. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Toward Remote Assessment of Physical Frailty Using Sensor-based Sit-to-stand Test. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Predictors of mobility in community-dwelling women aged 85 and older. [2013]

9. England pubmed.ncbi.nlm.nih.gov

What is the optimal chair stand test protocol for older adults? A systematic review. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Physical activity and physical fitness assessments in adolescents and young adults diagnosed with cancer: a scoping review. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Development and validation of a new short and simple measure of physical function for juvenile idiopathic arthritis. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Reference values for the 6-minute walk test in healthy children and adolescents in Switzerland. [2021]