Clinical trial · Interventional
Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors
Intensive Tailored Exercise Training With NAD+ Precursor Supplementation to Improve Muscle Mass and Fitness in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors
NCT05194397CI-TRIAL-00098418IAMFITrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aplastic Anemia | — | UNRESOLVED | — |
| Cancer Survivors | — | UNRESOLVED | — |
| Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloid Leukemia | Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Intervention | Other | — | UNRESOLVED |
| Nicotinamide Riboside | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Nicotinamide Riboside (NR)
- description
- Investigators will use Good Manufacturing Process (GMP)-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). Investigators dose based on body weight, and monitor for adverse effects (AEs). For individuals with weight \> 72 kg: 900 mg po qd x 16 wks. For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 16 wks. For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 16 wks.
- interventionNames
- Dietary Supplement: Nicotinamide Riboside
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule). Doses of placebo will match the body weight schema for dosing of NR. Investigators dose based on body weight, and monitor for adverse effects (AEs). For individuals with weight \> 72 kg: 900 mg po qd x 16 wks. For individuals with weight \> 48 kg and ≤ 72 kg: 600 mg po qd x 16 wks. For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 16 wks.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males and females, ages 10-30 years at enrollment 2. Able to understand and speak English 3. Diagnosis of leukemia (myeloid, lymphoid), aplastic anemia, bone marrow failure syndrome, or myelodysplastic syndrome requiring allogeneic HCT 4. 6-48 months from allogeneic HCT 5. 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. 6. Subject's informed consent or parental/guardian permission (informed consent) and if appropriate, child assent 7. Minimum weight of 24 kg Exclusion Criteria: 1. Known sensitivity to NR 2. Concurrent use of any medications, including statins, likely to increase risk of NR toxicity 3. Active malignancy, investigational agent(s) within 4 wks, or supraphysiological glucocorticoids at the baseline visit 4. Currently meeting public health exercise guidelines 5. Use of NAD+ precursors (supra-physiologic) within 4 weeks 6. Hemoglobin \< 10 g/dL 7. Platelets \< 50K 8. Diabetes Mellitus requiring insulin or insulin secretagogue 9. 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. 10. Kidney disease (eGFR \< 60 ml/min/1.73 m2) 11. Liver disease Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) (ALT/AST \> 3 x ULN) 12. Limitations in physical function preventing exercise testing/training 13. Unstable angina or history of acute myocardial infarction (\<5 days of planned study procedures) 14. Recurrent syncope 15. Symptomatic severe aortic stenosis 16. Uncontrolled arrhythmia causing symptoms 17. Pulmonary embolus \<3 months of study procedures 18. Thrombosis of lower extremities 19. Symptomatic moderate or severe persistent asthma based on Forced Expiratory Volume (FEV) from pre-HCT pulmonary function testing 20. Room air desaturation at rest ≤85% 21. Females: Pregnant or planning pregnancy 22. 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) 23. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 24. 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. 25. Current weight precludes safe completion of study procedures
References
Publications (1)
- DERIVEDSong M, Armenian SH, Bhandari R, Lee K, Ness K, Putt M, Lindenfeld L, Manoukian S, Wade K, Dedio A, Guzman T, Hampton I, Lin K, Baur J, McCormack S, Mostoufi-Moab S. Exercise training and NR supplementation to improve muscle mass and fitness in adolescent and young adult hematopoietic cell transplant survivors: a randomized controlled trial 1. BMC Cancer. 2022 Jul 19;22(1):795. doi: 10.1186/s12885-022-09845-1. PMID 35854224