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

NCT05023993 | Active Not Recruiting DMC

• 3 other identifiers: 20676NCI-2021-02807P30CA033572
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Prediabetes

Outcome Measures

Primary Outcomes (1)

• Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS)

  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

Study Arms (2)

Arm I (home exercise)

ACTIVE COMPARATOR

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

Other: Exercise Intervention

Arm II (home exercise, nicotinamide riboside)

EXPERIMENTAL

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

Other: Exercise Intervention; Dietary Supplement: Nicotinamide Riboside

Interventions

Exercise Intervention OTHER

Complete home exercise

Arm I (home exercise); Arm II (home exercise, nicotinamide riboside)

Nicotinamide Riboside DIETARY_SUPPLEMENT

Given PO

Also known as: Niagen, NR

Arm II (home exercise, nicotinamide riboside)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Prediabetic State

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rusha Bhandari

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 27, 2021
• Study Start: June 23, 2022
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): September 21, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)