- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01645436
Physical Activity in Pediatric Cancer (PAPEC) (PAPEC)
Physical Activity in Pediatric Cancer Patients With Solid Tumor Trial
Studieoversikt
Detaljert beskrivelse
Sixty patients, of both sexes, children will be recruited for this trial with an age range between 4 to 16 years old, undergoing treatment for primary tumors (excluding central nervous system tumors). Each participant will be assigned randomly (with blocking on sex) to either intervention or control (usual care) group.
The intervention group will participate in combined inpatient physical training (aerobic + strength) over neoadjuvant chemotherapy. The intervention will include three weekly exercise sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym specifically enabled on the aforementioned hospital, depending on the children's health status.
Primary outcomes [cardio-respiratory capacity (peak oxygen uptake), muscle strength (6RM leg and bench press, and lateral row), functional capacity ('Timed Up and Down Stairs test', and '3 m and 10m Time Up and Go tests'), physical activity levels (determined by accelerometry) and quality of life "Child Report Form of the Child's Health and Illness Profile-Child Edition", Adolescent Edition and Parents Report Form )] and secondary outcomes [immune function (immune cell subpopulations, natural killer cells' cytotoxicity), inflammatory profile (blood levels of 47 cytokines) and leukocyte telomere length] will be measured in both groups in the following time points:
(i) before the exercise intervention (immediately after diagnosis and before the start of treatment); (ii) after the exercise intervention (upon termination of neoadjuvant chemotherapy); and iii) after a detraining period (2 months after the intervention).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Madrid, Spania, 28009
- Hospital Infantil Universitario Nino Jesus
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- age range between 4 to 16 years old, undergoing treatment for primary tumors (excluding central nervous system tumors) treated in the Hospital Infantul Niño jesús and residents in Madrid community. -
Exclusion Criteria:
- age<4 years or >16 years, other tumours
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: treatment (exercise)
combined inpatient physical training (aerobic + strength) over neoadjuvant chemotherapy.
The intervention will include three weekly exercise sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym specifically enabled on the aforementioned hospital, depending on the children's health status.
|
The intervention group will participate in combined inpatient physical training (aerobic + strength) over neoadjuvant chemotherapy.
The intervention will include three weekly exercise sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym specifically enabled on the aforementioned hospital, depending on the children's health status.
Andre navn:
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Ingen inngripen: control (usual care)
Usual hospital care with no exercise
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Muscle strength (kg) measured in 5-repetition maximum (5RM) leg and bench press and lateral row exercise tests
Tidsramme: up to 3 years
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up to 3 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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inflammatory profile
Tidsramme: up to 3 years
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blood levels of 47 cytokines (including, among others, interferon (IFN) α2, IFNγ, interleukin (IL)1α, IL1ß, IL1ra, IL2, IL2RA, IL3, IL4, IL6, IL7, IL8, IL9, IL10, IL12, IL13, IL15, IL16, IL17, tumor necrosis factor(TNF)-related apoptosis-inducing ligand, and TNFα.
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up to 3 years
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Alejandro Lucia, MD PhD, Universidad Europea de Madrid
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- LUCIA
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