Clinical trial NCT05023993: The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Prediabetes
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS)
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Rusha Bhandari
role: PRINCIPAL_INVESTIGATOR
References: