Medulloblastoma Online Video-based Exercise Pilot Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Years - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

Completed therapy for medulloblastoma, including craniospinal radiation therapy, within 36 months before study entry.

-
Exclusion Criteria:
Inability to walk without support.

Progressive disease. -

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06898684
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Aron Onerup
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Medulloblastoma, Childhood

Additional Details

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).

Arms & Interventions

Arms

Experimental: Exercise

Video-supervised exercise, offered three times per week for 12 weeks, followed by behavioral support towards incorporating physical activity into daily life for an additional 12 weeks.

Interventions

Behavioral: - Exercise

Moderate-high intensity exercise, with three sessions per week during 12 weeks. Includes both aerobic and resistance training and will also include exercises that strengthen coordination and balance.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Aron Onerup, MD, PhD

[email protected]

+46766185619

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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