Clinical trial NCT06898684: Medulloblastoma Online Video-based Exercise Pilot Study
Official title: Medulloblastoma Online Video-based Exercise Pilot Study (MOVE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Medulloblastoma, Childhood
Keywords: exercise
rehabilitation
medulloblastoma
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
name: Uppsala University
name: Region Västerbotten
name: Region Stockholm
name: Region Östergötland
name: Region Skane
name: Technical University of Munich
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2025-03-27
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the investigators test whether it is possible to deliver an exercise intervention via video meetings to children and adolescents who have completed therapy for medulloblastoma. The exercise sessions will be individualized and offered three times weekly during 12 weeks.

Detailed description: Tumors of the central nervous system (CNS) represent 25-30% of all cases of pediatric cancer in Sweden. The survival for children with a brain tumor has improved over the last years. The 5-year overall survival rate is now 70%, resulting in a growing number or survivors every year. Malignant brain tumors typically have a poor prognosis, and curative treatment usually requires a combination of neurosurgery, chemotherapy and/or radiotherapy. For the survivors, the cure often comes at the cost of long-term side effects. Finding effective ways to mitigate the long-term side effects after childhood brain tumor is important, since they can severely impact the survivors´ daily life.

There is growing evidence that physical exercise is beneficial to cognition and improves cardiorespiratory fitness and motor function. It appears to be important that interventions start early, within 1-2 years after radiotherapy. For this to be feasible in international multicenter trials, the intervention and outcome assessments will need to be delivered remotely. Whether this is feasible in children treated for medulloblastoma is not known.

The investigators will perform a pilot study to provide pivotal information on whether exercise training can be remotely delivered in the home environment in children treated for medulloblastoma. This will take exercise training from an interesting research concept into a scalable intervention that can be offered regardless of geographic location of the patient. The study will further define the validity and feasibility of in-home outcome assessments of cardiorespiratory, muscular fitness and motor function in children treated for medulloblastoma. If shown feasible, this will work as a proof-of-concept and lead the way for including physical activity intervention in other childhood cancer treatment protocols as well. The results from this study will also enable the researchers to proceed in the planning of the first exercise intervention to be included upfront in an international childhood cancer treatment protocol, the upcoming Pan-European treatment protocol for standard-risk medulloblastoma in children (SIOP-MB6).

Eligibility criteria: Inclusion Criteria: Completed therapy for medulloblastoma, including craniospinal radiation therapy, within 36 months before study entry.

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Exclusion Criteria: Inability to walk without support. Progressive disease.

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Primary outcomes:
measure: Participation rate in the intervention
timeFrame: From enrollment to the end of exercise at 12 weeks and then for prolonged support for another 12 weeks.
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 12 weeks
Secondary outcomes:
measure: Handgrip strength
timeFrame: Change from baseline, until 3 and 12 months.
measure: Physical activity
timeFrame: Change from baseline, until 1.5, 3, 6, and 12 months.
measure: Patient-reported quality of life
timeFrame: Change from baseline, until 3 and 12 months.
measure: Motor function
timeFrame: Change from baseline, until 3 and 12 months.
measure: Cardiorespiratory fitness
timeFrame: Change from baseline, until 3 and 12 months.
measure: Epigenetic age acceleration
timeFrame: Change from baseline, until 3 and 12 months.
measure: Feasibility of the outcome measures
timeFrame: 12 weeks
measure: Cognitive function
timeFrame: Change from baseline to 12 weeks and 12 months.
Other outcomes:
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