Hematopoietic and Lymphoid Cell NeoplasmNCT05023993
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
A study testing Exercise Intervention and Nicotinamide Riboside in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Prediabetes
- What is being tested?
- Exercise Intervention and Nicotinamide Riboside
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to 7 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Ability to tolerate the prescribed resistance exercise program
- English-speaking
- Able to understand and sign the study specific informed consent form (ICF)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the feasibility of conducting a home exercise and nutrition intervention in childhood cancer survivors (CCS) with a history of prediabetes.
EXPLORATORY OBJECTIVES:
- 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.
- Being tested
- Exercise Intervention, Nicotinamide Riboside
- Medical subject headings
- Hematologic Neoplasms, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionOther
Complete home exercise
Nicotinamide RibosideDietary supplement
Also called Niagen, NR
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (home exercise) | Active comparator | Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks. Receives: Other: Exercise Intervention |
| Arm II (home exercise, nicotinamide riboside) | Experimental | Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks. Receives: Other: Exercise Intervention; Dietary Supplement: Nicotinamide Riboside |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start23 Jun 2022
- Primary completion7 Sep 2027 (estimated)
- Study completion7 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rusha Bhandari, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023993
- Sponsor's protocol ID
- 20676
- Other IDs
- NCI-2021-02807, 20676, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2021
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No