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临床试验 NCT05023993 针对造血和淋巴细胞肿瘤，恶性实体肿瘤，糖尿病前期目前进行中但不再招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
希望之城国家医学中心The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
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.
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
- 20676
- NCI-2021-02807 (注册标识符) (CTRP (Clinical Trial Reporting Program))
- 20676 (其他标识符) (City of Hope Medical Center)
- P30CA033572 (美国 NIH 拨款/合同)
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照Arm I (home exercise) Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks. | 运动干预 Complete home exercise |
实验性Arm II (home exercise, nicotinamide riboside) Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks. | 运动干预 Complete home exercise Nicotinamide Riboside Given PO |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS) | 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. | Up to 6 weeks |
- 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)
- 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
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