The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer

November 6, 2025 updated by: City of Hope Medical Center

The Effect of Exercise and Nicotinamide Riboside on Muscle Health and Insulin Resistance in Adult Survivors of Childhood Cancer With Prediabetes: A Pilot Feasibility Study

This trial studies the effect of exercise and nicotinamide riboside on muscle health and insulin resistance in adult survivors of childhood cancer with prediabetes (elevated blood sugar level that is not high enough to be considered diabetes). Nicotinamide riboside is a dietary supplement which is similar to vitamin B3. Information collected in this study may help the future development of regimens to improve metabolic outcomes such as muscle health and insulin resistance (when the body is not normally responding to insulin) in childhood cancer survivors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of conducting a home exercise and nutrition intervention in childhood cancer survivors (CCS) with a history of prediabetes.

EXPLORATORY OBJECTIVES:

I. Describe the association between patient demographics and treatment exposures and subsequent hyperglycemia and skeletal muscle health in childhood cancer survivors.

II. Describe the effect of exercise with or without nicotinamide riboside (NR) on hyperglycemia and skeletal muscle health in CCS with a history of prediabetes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.

ARM II: Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside orally (PO) daily for 6 weeks.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of childhood cancer
  • History of prediabetes (HbA1c 5.7-6.4%)
  • In remission at time of enrollment
  • Time between completion of cancer-directed therapy and study entry: >= 6 months
  • At least 18 years of age at time of enrollment
  • Able to access online exercise program at home
  • Ability to tolerate the prescribed resistance exercise program
  • English-speaking
  • Able to understand and sign the study specific informed consent form (ICF)

Exclusion Criteria:

  • Taking a nicotinamide adenine dinucleotide (NAD)+ precursor in the two weeks prior to enrollment
  • Currently taking medication for hyperglycemia or diabetes
  • Females who are pregnant or planning to become pregnant
  • Currently recovering from an injury
  • Contraindication to magnetic resonance imaging (MRI)
  • Pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (home exercise)
Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.
Other: Exercise Intervention
Complete home exercise
Experimental: Arm II (home exercise, nicotinamide riboside)
Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks.
Other: Exercise Intervention
Complete home exercise
Dietary supplement: Nicotinamide Riboside
Given PO
Other Names:
  • Niagen
  • NR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS)
Time Frame: Up to 6 weeks

The current protocol will be considered feasible if:

  1. >= 50% of eligible patients that are approached for participation enroll onto the study,
  2. >= 70% of enrolled participants successfully complete all study assessments (i.e. physical function tests, blood draw, imaging, and questionnaires at baseline and 6 weeks, and
  3. Enrolled participants demonstrate >= 70% compliance with prescribed exercise and nicotinamide riboside.

Feasibility measures 2 and 3 will be assessed for the entire group of 20 subjects as a whole.
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Rusha Bhandari, City of Hope Medical Center

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 Major Dates

Study Start (Actual)

June 23, 2022

Primary Completion (Estimated)

September 21, 2026

Study Completion (Estimated)

September 21, 2026

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 20, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Estimated)

November 7, 2025

Last Update Submitted That Met QC Criteria

November 6, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20676 (Other Identifier: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2021-02807 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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