The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Primary Purpose
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Prediabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Nicotinamide Riboside
Sponsored by
About this trial
This is an interventional supportive care trial for Hematopoietic and Lymphoid Cell Neoplasm
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
Sites / Locations
- City of Hope Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm I (home exercise)
Arm II (home exercise, nicotinamide riboside)
Arm Description
Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.
Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05023993
First Posted
August 4, 2021
Last Updated
July 3, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05023993
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Prediabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (home exercise)
Arm Type
Active Comparator
Arm Description
Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.
Arm Title
Arm II (home exercise, nicotinamide riboside)
Arm Type
Experimental
Arm Description
Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Complete home exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotinamide Riboside
Other Intervention Name(s)
Niagen, NR
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS)
Description
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.
Time Frame
Up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rusha Bhandari
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rusha Bhandari
Phone
626-256-4673
Ext
81102
Email
rbhandari@coh.org
First Name & Middle Initial & Last Name & Degree
Rusha Bhandari
12. IPD Sharing Statement
Learn more about this trial
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
We'll reach out to this number within 24 hrs