Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Jan 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how exercise and a supplement called NR (which helps boost energy in cells) can improve fitness and muscle strength in young people aged 10 to 30 who have survived certain types of cancer treatments, specifically those who have undergone a stem cell transplant. The main goal is to see if these interventions can help increase muscle strength over 16 weeks. Eligible participants must have been diagnosed with leukemia or related conditions and should be between 6 to 48 months post-transplant. They should also be able to speak and understand English and weigh at least 24 kg.

If you or someone you know qualifies, participants will engage in exercise training and take either the NR supplement or a placebo (a non-active version) for comparison. Throughout the study, they’ll be monitored to assess changes in their muscle strength, grip strength, and overall fitness levels. It's important to note that certain health conditions or medications may prevent someone from participating, so a healthcare professional will closely evaluate eligibility. This trial could potentially help improve the quality of life for cancer survivors by enhancing their physical abilities.

Gender

ALL

Eligibility criteria

• 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, 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