治験レーダーAI | ||
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治験 NCT05023993（対象：造血およびリンパ系細胞腫瘍、悪性固形腫瘍、前糖尿病）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
シティ・オブ・ホープ医療センター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 (登録識別子) (CTRP (Clinical Trial Reporting Program))
- 20676 (その他の識別子) (City of Hope Medical Center)
- P30CA033572 (米国NIHの助成金/契約)
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬Arm I (home exercise) Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks. | 運動介入 Complete home exercise |
実験的Arm II (home exercise, nicotinamide riboside) Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks. | 運動介入 Complete home exercise Nicotinamide Riboside Given PO |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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
シティ・オブ・ホープ医療センター343 件のアクティブな治験を探索アメリカ国立がん研究所3028 件のアクティブな治験を探索California