Clinical trial NCT04353063: Muscle Wasting in Children and Adolescents With Cancer
Official title: Assessment and Management of Muscle Wasting in Children and Adolescents With Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cachexia; Cancer
Muscle Wasting
Child Development
Adolescent Development
Keywords: symptom distress
nutrition
physical activity
body composition
children and adolescents
cancer
nursing care
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 440
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The series of the 3-year study aims to explore parents' experience of caring for a child's weight change among parents of children and adolescents with cancer, examine the associations and trends among muscle wasting and health-related variables, and then implement and assess effectiveness of a multidisciplinary approach with a personalized physical activity (walking) training intervention on improving muscle mass and other health-related variables.

Detailed description: Specific aims, year by year

1. The aim for Year 1 is as follows:

   Aim 1: To explore parents' experience of caring for promoting a child's exercise among parents of children and adolescents with cancer.
2. The aims for Year 2 are as follows:

   Aim 2-1: To examine the associations between the degree of muscle wasting and health-related variables (fatigue level, symptom distress level, physical activity involvement, dietary intake, and QoL) among children and adolescents with cancer.

   Aim 2-2: To examine the trends of changes in muscle wasting and health-related variables (fatigue level, symptom distress level, physical activity involvement, dietary intake, and QoL) during the first 6 months of cancer treatment among children and adolescents with cancer.
3. The aim for Year 3 is as follows:

Aim 3: To examine the effectiveness of a multidisciplinary approach with a personalized walking exercise program on changes in body composition and health-related variables (fatigue level, symptom distress level, subjective physical activity involvement, objective physical activity measurement, dietary intake, and QoL) among children and adolescents with cancer.

Eligibility criteria: Inclusion Criteria:

* Aim 1:(1) parents of children diagnosed with malignancies at 3-18 years old, (2) whose children have received cancer treatment for at least 6 months, (3) who are the main caregivers, and (4) who are willing to participate in the study.
* Aim 2-1:(1) children and adolescents diagnosed with malignancies at 3-18 years old, (2) who are previously or currently treated for cancer, and (3) who are willing to participate in the study. Two hundred patients will be recruited.
* Aim 2-2:(1) children and adolescents diagnosed with malignancies at 3-18 years old, (2) newly diagnosed with cancer within the past 1 month, and (3) willing to participate in the study. One hundred participants will be recruited.
* Aim 3:(1) children and adolescents aged 3-18 years old and are undergoing treatment, and (2) who are willing to participate in the study.

Exclusion Criteria:

-Aim 1-3: Children and adolescents are under poor physical or cognitive conditions.

Primary outcomes:
measure: Demographics
timeFrame: baseline
measure: Lab data
timeFrame: baseline
measure: Medication dosage
timeFrame: baseline
measure: Cachexia assessment
timeFrame: baseline
measure: Inbody S10
timeFrame: Week 0
measure: Inbody S10
timeFrame: Week 4
measure: Multidimensional Fatigue Scale (MFS):
timeFrame: week 4
measure: Symptom Distress Scale (SDS)
timeFrame: Week 0(baseline)
measure: Symptom Distress Scale (SDS)
timeFrame: week 1
measure: Symptom Distress Scale (SDS)
timeFrame: week 2
measure: Symptom Distress Scale (SDS)
timeFrame: week 3
measure: Symptom Distress Scale (SDS)
timeFrame: week 4
measure: Exercise Involvement Scale (EIS)
timeFrame: Week 0(baseline)
measure: Exercise Involvement Scale (EIS)
timeFrame: week 1
measure: Exercise Involvement Scale (EIS)
timeFrame: week 2
measure: Exercise Involvement Scale (EIS)
timeFrame: week 3
measure: Exercise Involvement Scale (EIS)
timeFrame: week 4
measure: Visual analogue scale for dietary intake (VAS-DI)
timeFrame: Week 0(baseline)
measure: Visual analogue scale for dietary intake (VAS-DI)
timeFrame: week 1
measure: Visual analogue scale for dietary intake (VAS-DI)
timeFrame: week 2
measure: Visual analogue scale for dietary intake (VAS-DI)
timeFrame: week 3
measure: Visual analogue scale for dietary intake (VAS-DI)
timeFrame: week 4
measure: PedsQL
timeFrame: Week 0(baseline)
measure: PedsQL
timeFrame: week 4
measure: ActiGraph
timeFrame: Week 0(baseline)
measure: ActiGraph
timeFrame: week 1
measure: ActiGraph
timeFrame: week 2
measure: ActiGraph
timeFrame: week 3
measure: ActiGraph
timeFrame: week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: National Taiwan University, College of Medicine
name: Wei-Wen Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: