RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Intensive Tailored Exercise Training With NAD+ Precursor Supplementation to Improve Muscle Mass and Fitness in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors

Quick Facts

Study Start:2023-02-23
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05194397

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males and females, ages 10-30 years at enrollment
  2. 2. Able to understand and speak English
  3. 3. Diagnosis of leukemia (myeloid, lymphoid), aplastic anemia, or myelodysplastic syndrome requiring allogeneic HCT
  4. 4. 6-48 months from allogeneic HCT
  5. 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. 6. Parental/guardian permission (informed consent) and if appropriate, child assent
  7. 7. Minimum weight of 24 kg
  1. 1. Known sensitivity to NR
  2. 2. Concurrent use of any medications, including statins, likely to increase risk of NR toxicity
  3. 3. Active malignancy, investigational agent(s) within 4 wks, or supraphysiological glucocorticoids at the baseline visit
  4. 4. Currently meeting public health exercise guidelines1
  5. 5. Use of NAD+ precursors (supra-physiologic) within 4 weeks
  6. 6. Hemoglobin \< 10 g/dL
  7. 7. Platelets \< 50K
  8. 8. Diabetes Mellitus requiring insulin or insulin secretagogue
  9. 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. 10. Kidney disease (eGFR \< 60 ml/min/1.73 m2)
  11. 11. Liver disease Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) (ALT/AST \> 3 x ULN)
  12. 12. Limitations in physical function preventing exercise testing/training
  13. 13. Unstable angina or history of acute myocardial infarction (\<5 days of planned study procedures)
  14. 14. Recurrent syncope
  15. 15. Symptomatic severe aortic stenosis
  16. 16. Uncontrolled arrhythmia causing symptoms
  17. 17. Pulmonary embolus \<3 months of study procedures
  18. 18. Thrombosis of lower extremities
  19. 19. Symptomatic moderate or severe persistent asthma based on Forced Expiratory Volume (FEV )from pre-HCT pulmonary function testing
  20. 20. Room air desaturation at rest ≤85%
  21. 21. Females: Pregnant or planning pregnancy
  22. 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. 23. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
  24. 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.

Contacts and Locations

Study Contact

Susan Lee
CONTACT
267-602-4603
leess@chop.edu
Kristin Wade
CONTACT
267-398-5761
wadekl@chop.edu

Principal Investigator

Sogol Mostoufi-Moab, MD, MSCE
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

  • Sogol Mostoufi-Moab, MD, MSCE, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-23
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-02-23
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Sarcopenia
  • NAD+
  • Exercise Intervention
  • OXPHOS Capacity
  • VO2 Max
  • Adolescent young adults
  • Cancer Survivors
  • Hematopoietic Stem Cell Transplantation (HCT)

Additional Relevant MeSH Terms

  • Lymphoblastic Leukemia
  • Cancer Survivors
  • Aplastic Anemia
  • Myelodysplastic Syndromes
  • Myeloid Leukemia