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NR Supplementation + Exercise for Cancer Survivors (IAMFIT Trial)
Phase 2
Recruiting
Led By Sogol Mostoufi-Moab, MD, MSCE
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females, ages 10-30 years at enrollment
Minimum weight of 24 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 16 weeks
Awards & highlights
IAMFIT Trial Summary
This trial will test the effects of an NAD+ precursor and exercise on skeletal muscle quality and VO2max in AYA HCT survivors. The primary outcome is the change in muscle strength from baseline to 16 weeks.
Who is the study for?
This trial is for AYA HCT survivors aged 10-30 who speak English and are 6-48 months post-transplant. They must weigh at least 24 kg, not be pregnant, use contraception if applicable, and have parental consent if under age. Excluded are those with NR sensitivity, certain health conditions like severe diabetes or liver disease, recent heart issues or blood clots, asthma affecting lung function tests pre-HCT, or currently meeting exercise guidelines.Check my eligibility
What is being tested?
The study examines the impact of Nicotinamide Riboside (NR) supplementation and an exercise program on muscle strength and aerobic capacity in young cancer survivors. Participants will randomly receive either NR or a placebo while undergoing an exercise regimen to see how these interventions affect their physical fitness over a period of 16 weeks.See study design
What are the potential side effects?
Potential side effects may include reactions to NR for those with known sensitivities. Exercise might cause typical workout-related discomforts such as muscle soreness. The trial excludes individuals likely to experience increased risk of NR toxicity due to other medications.
IAMFIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 10 and 30 years old.
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I weigh at least 24 kg.
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I am not pregnant and will use birth control during the study.
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I have leukemia, aplastic anemia, or myelodysplastic syndrome and need a bone marrow transplant.
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I had a stem cell transplant from a donor between 6 to 48 months ago.
IAMFIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Within participant changes in muscle strength (Isometric knee extension, Z-score)
Secondary outcome measures
Within participant change in aerobic capacity (VO2 max, Maximal Oxygen Uptake on Cardiopulmonary Exercise Testing).
Within participant change in grip strength (Hand Grip Dynamometry)
Within participant change in muscle strength (Ankle Plantarflexion)
+2 moreIAMFIT Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Nicotinamide Riboside (NR)Experimental Treatment1 Intervention
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.
Group II: Exercise Intervention and PlaceboExperimental Treatment2 Interventions
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
Group III: Exercise Intervention and NRExperimental Treatment2 Interventions
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.
Group IV: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Nicotinamide Riboside
2022
N/A
~160
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
710 Previous Clinical Trials
8,588,828 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,147 Total Patients Enrolled
1 Trials studying Cancer Survivors
96 Patients Enrolled for Cancer Survivors
City of Hope Medical CenterOTHER
570 Previous Clinical Trials
1,922,536 Total Patients Enrolled
15 Trials studying Cancer Survivors
3,821 Patients Enrolled for Cancer Survivors
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe symptoms from a narrowed heart valve.I am pregnant or planning to become pregnant.I do not have any health conditions that worsen with exercise.I take insulin or medication to increase insulin for my diabetes.I cannot do exercise tests or training due to physical limitations.My liver enzymes are not more than three times the upper limit.I have had blood clots in my legs.I haven't taken high doses of NAD+ boosters in the last 4 weeks.I am between 10 and 30 years old.I weigh at least 24 kg.I am not taking medications that increase the risk of nerve damage.My kidney function is reduced.I have not had a recent heart attack or unstable chest pain.I have moderate or severe asthma as shown by my lung function tests.I am not pregnant and will use birth control during the study.I haven't taken experimental drugs or high-dose steroids in the last 4 weeks.I have experienced fainting spells more than once.I have leukemia, aplastic anemia, or myelodysplastic syndrome and need a bone marrow transplant.I had a stem cell transplant from a donor between 6 to 48 months ago.I have a heart rhythm problem that causes symptoms and is not under control.I have not had a pulmonary embolus in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Nicotinamide Riboside (NR)
- Group 2: Placebo
- Group 3: Exercise Intervention and NR
- Group 4: Exercise Intervention and Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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