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

NCT ID: NCT05023993

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-23

Study Completion Date

2026-09-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (home exercise)

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

Group Type ACTIVE_COMPARATOR

Exercise Intervention

Intervention Type OTHER

Complete home exercise

Arm II (home exercise, nicotinamide riboside)

Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type OTHER

Complete home exercise

Nicotinamide Riboside

Intervention Type DIETARY_SUPPLEMENT

Given PO

Interventions

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Exercise Intervention

Complete home exercise

Intervention Type OTHER

Nicotinamide Riboside

Given PO

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Niagen NR

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rusha Bhandari

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2021-02807

Identifier Type: REGISTRY

Identifier Source: secondary_id

20676

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20676

Identifier Type: -

Identifier Source: org_study_id