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

City of Hope

Status: Active, not recruiting

Conditions: Prediabetes; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Treatments: Dietary Supplement: Nicotinamide Riboside; Other: Exercise Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05023993

NCI-2021-02807 (Registry Identifier)

20676 (Other Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Arm I (home exercise)

Active Comparator group

Description:

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

Treatment:

Other: Exercise Intervention

Arm II (home exercise, nicotinamide riboside)

Experimental group

Description:

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

Treatment:

Other: Exercise Intervention

Dietary Supplement: Nicotinamide Riboside