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Nicotinamide

Nicotinic Acid

Vitamin B3

Folate

Vitamin B9

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.

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.

The exercise program consists of at-home training sessions including: aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity, and twice weekly strength training exercises.

Participants in this arm will receive both the Exercise Intervention and the NR.

The exercise program consists of at-home training sessions including: aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity, and twice weekly strength training exercises.

Participants in this arm will receive both the Exercise Intervention and the Placebo

Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA).

NR is distributed by ChromaDex, Inc., Irvine, CA. NR is available as 300 mg capsules.

The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.

Nicotinamide Riboside

The 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)

Placebo

The exercise program consists of at-home training sessions and will include aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity, and twice weekly strengthening over 16 weeks. For aerobic training, the eventual intensity and duration goal (adapted for each person as necessary) will be for persons to train at 70-80% of peak 2MSPT heart rate 20-45 minutes 3-5 days/week. For resistance exercises the goal will be a load/weight that results in fatigue after 3 sets of 10-12 repetitions on 8-10 exercises 2 days/week.

Exercise Intervention

Minkeun Song

Kristin Wade

Lanie Lindenfeld, MA, CCRP

Saro H Armenian, DO, MPH

Susan Lee

Sogol Mostoufi-Moab, MD, MSCE

Sarah Terrell, MS

Kirsten K. Ness, PhD

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.

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.

Randomized, placebo-controlled trial with a 2x2 factorial design testing the effects of an NAD+ precursor (NR) and exercise.

The participants and the investigator team will be blinded as to the group assignment: NR vs Placebo. All collected data (e.g., questionnaires) will be coded, so initial analysis will be conducted without knowledge of the participant's group status.

While the assignment of participants to the exercise groups will not be blinded to the participant or majority of the study team, a designated blinded technician will perform the follow-up Cardio Pulmonary Exercise Testing. Follow-Up Cardio Pulmonary Exercise Testing will be performed by a dedicated blinded study team member, an exercise technician, who will not know if the participant was assigned to an arm including the exercise intervention.

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

No identifiable data will be used for future study without first obtaining IRB approval. The investigator will obtain a fully executed data use agreement between the provider (the PI) of the data and any recipient researchers \[(including others at CHOP) before sharing a limited dataset (or the data will only be provided to users under a fully executed data use (or data sharing) agreement approved by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB)\]. The execution of the agreement will require approval by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) or a demonstration of IRB exemption per institutional policy.

Muscle Strength will be assessed by completion of isometric contractions using a Biodex dynamometer.

Grip Strength will be assessed using a hand grip dynamometry device.

Muscle mass will be assessed by completion of whole body DXA scanning.

OXPHOS capacity will be assessed by completion of non-invasive MRI scanning using creatine chemical exchange saturation transfer (CrCEST).

VO2 Max will be assessed by completion of an incremental cardio-pulmonary Exercise Stress Test (EST) on an upright leg cycle ergometer

Spots Global Cancer Trial Database for vo2 max

Every month we try and update this database with for vo2 max cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for vo2 max

Every month we try and update this database with for vo2 max cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vo2 max cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.