Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Prediabetes
Conditions
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.
Detailed 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.
Interventions
OTHERExercise Intervention
Complete home exercise
DIETARY_SUPPLEMENTNicotinamide Riboside
Given PO
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS) | Up to 6 weeks | 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. |
Countries
United States
Outcome results
None listed