This will be a randomized, placebo-controlled trial with a 2x2 factorial design testing
the effects of an NAD+ precursor (NR) and exercise on skeletal muscle quality and VO2max
in AYA HCT survivors.
The primary outcome is the change in muscle strength (isometric knee extension) from
baseline to 16 weeks. Key secondary outcomes are the change in muscle strength (ankle
plantarflexion) from baseline to 16 weeks, the change in grip strength from baseline to
16 weeks, the change in lower extremity muscle mass from baseline to 16 weeks, the change
in muscle OXPHOS capacity from baseline to 16 weeks, and the change in aerobic capacity
(VO2 max) from baseline to 16 weeks.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05194397.
Locations matching your search criteria
United States
Tennessee
Memphis
Saint Jude Children's Research HospitalStatus: Active
Name Not Available
Adolescents and young adults (AYAs) who undergo hematopoietic cell transplantation (HCT)
are at an especially high risk of developing sarcopenia (loss of skeletal muscle mass),
which occurs earlier than would be expected from advancing age alone. This is important
as not only it doubles their risk for non-relapse mortality, but it also leads to
premature cardiovascular disease. The investigators propose a mechanistic randomized
controlled trial of home-based remotely supervised exercise (aerobic and resistance)
training and supplementation with nicotinamide riboside, a precursor of NAD+, a
metabolite that is critical for muscle metabolism, in AYA survivors of HCT. The findings
will lay the critical groundwork for future trials to prevent or mitigate the myriad
downstream adverse effects of low muscle mass in AYA HCT survivors.
Lead OrganizationChildren's Hospital of Philadelphia
