Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors (NCT05194397) | Clinical Trial Compass
RecruitingPhase 2
Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors
United States80 participantsStarted 2023-02-23
Plain-language summary
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.
Who can participate
Age range10 Years – 30 Years
SexALL
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Inclusion criteria
✓. Males and females, ages 10-30 years at enrollment
✓. Able to understand and speak English
✓. Diagnosis of leukemia (myeloid, lymphoid), aplastic anemia, bone marrow failure syndrome, or myelodysplastic syndrome requiring allogeneic HCT
✓. 6-48 months from allogeneic HCT
✓. Females must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
✓. Subject's informed consent or parental/guardian permission (informed consent) and if appropriate, child assent
✓. Minimum weight of 24 kg
Exclusion criteria
✕. Known sensitivity to NR
✕. Concurrent use of any medications, including statins, likely to increase risk of NR toxicity
What they're measuring
1
Within participant changes in muscle strength (Isometric knee extension, Z-score)