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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 16 weeks for reporting.

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 more

IAMFIT 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

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,580,979 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,700 Previous Clinical Trials

7,506,796 Total Patients Enrolled

1 Trials studying Cancer Survivors

96 Patients Enrolled for Cancer Survivors

City of Hope Medical CenterOTHER

565 Previous Clinical Trials

1,921,380 Total Patients Enrolled

15 Trials studying Cancer Survivors

3,821 Patients Enrolled for Cancer Survivors

Media Library

Exercise Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05194397 — Phase 2

Cancer Survivors Research Study Groups: Nicotinamide Riboside (NR), Placebo, Exercise Intervention and NR, Exercise Intervention and Placebo

Cancer Survivors Clinical Trial 2023: Exercise Intervention Highlights & Side Effects. Trial Name: NCT05194397 — Phase 2

Exercise Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05194397 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we looking for more participants in this clinical trial at the moment?

"The trial, as per the information available on clinicaltrials.gov, is ongoing and looking for participants. The posting date was November 18th, 2022 with the most recent update occurring on November 3rd of the same year."

Answered by AI

How often do patients report negative side effects from the Exercise Intervention program?

"While there is evidence that the Exercise Intervention is safe, it only received a score of 2 because, at this stage in clinical trials, efficacy has not been statistically supported."

Answered by AI

Which patients would be the best candidates for this clinical trial?

"This leukemia clinical trial is only considering patients that are in remission and between the ages of 10-30. Out of the 80 total people they are hoping to enroll,"

Answered by AI