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Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors
Trial Status: active
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.
Inclusion Criteria
Males and females, ages 10-30 years at enrollment
Able to understand and speak English
Diagnosis of leukemia (myeloid, lymphoid), aplastic anemia, 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
Active malignancy, investigational agent(s) within 4 wks, or supraphysiological glucocorticoids at the baseline visit
Currently meeting public health exercise guidelines
Use of NAD+ precursors (supra-physiologic) within 4 weeks
Hemoglobin < 10 g/dL
Platelets < 50K
Diabetes Mellitus requiring insulin or insulin secretagogue
HbA1C ≥ 8% or fasting glucose > 125 mg/dL; However if the participant is diabetic, both fasting glucose level and HbA1C must meet the criteria to be deemed eligible.
Limitations in physical function preventing exercise testing/training
Unstable angina or history of acute myocardial infarction (<5 days of planned study procedures)
Recurrent syncope
Symptomatic severe aortic stenosis
Uncontrolled arrhythmia causing symptoms
Pulmonary embolus <3 months of study procedures
Thrombosis of lower extremities
Symptomatic moderate or severe persistent asthma based on Forced Expiratory Volume (FEV) from pre-HCT pulmonary function testing
Room air desaturation at rest ≤85%
Females: Pregnant or planning pregnancy
Non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (e.g. infection, renal failure, thyrotoxicosis, >moderate Graft versus host disease (GVHD) resulting in physical or functional impairment)
Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
For MRI procedure: Contraindications to MRI. Individuals will be screened to ensure they can safely complete the MRI. *participants who cannot complete the MRI will not be excluded from participation in the remainder of the study procedures if they meet those inclusion and exclusion criteria.
Current weight precludes safe completion of study procedures
Additional locations may be listed on ClinicalTrials.gov for NCT05194397.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Tennessee
Memphis
Saint Jude Children's Research Hospital
Status: 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.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationChildren's Hospital of Philadelphia
