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NCT Number: NCT05023993

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Malignant Solid Neoplasm Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases PreDiabetes Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise intervention

Other

Complete home exercise

Nicotinamide riboside

Dietary Supplement

Given PO

Other names: Niagen, NR

Primary outcomes

  1. 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:

    • >= 50% of eligible patients that are approached for participation enroll onto the study,
    • >= 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
    • 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2021
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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