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

Study Overview
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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.

Official Title
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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

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Prediabetes

Intervention / Treatment
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* Other: Exercise Intervention
* Dietary Supplement: Nicotinamide Riboside


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (home exercise)<br>Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks. | Other: Exercise Intervention<br>* Complete home exercise<br>|
| Experimental: Arm II (home exercise, nicotinamide riboside)<br>Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks. | Other: Exercise Intervention<br>* Complete home exercise<br>Dietary Supplement: Nicotinamide Riboside<br>* Given PO<br>* Other names: NR;|

What is the study measuring?
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Primary Outcome Measures

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