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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-02807 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20676 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (home exercise) | Active Comparator | Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Other | Complete home exercise |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS) | The current protocol will be considered feasible if:
Feasibility measures 2 and 3 will be assessed for the entire group of 20 subjects as a whole. | Up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rusha Bhandari | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Nicotinamide Riboside | Dietary Supplement | Given PO |
|
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
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