Status:
RECRUITING
Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
National Institutes of Health (NIH)
City of Hope Medical Center
Conditions:
Lymphoblastic Leukemia
Cancer Survivors
Eligibility:
All Genders
10-30 years
Phase:
PHASE2
Brief 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. ...
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
- Kidney disease (eGFR \< 60 ml/min/1.73 m2)
- Liver disease Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) (ALT/AST \> 3 x ULN)
- 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
Key Trial Info
Start Date :
February 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05194397
Start Date
February 23 2023
End Date
June 30 2026
Last Update
December 4 2025
Active Locations (3)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
3
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105