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Medizinisches Zentrum City of HopeThe Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
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Die klinische Studie NCT05023993 ist eine interventionsstudie zur Untersuchung von Neoplasma der hämatopoetischen und lymphoiden Zellen, Bösartige solide Neoplasie, Prädiabetes und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 23. Juni 2022 und soll 20 Teilnehmer aufnehmen. Durchgeführt von Medizinisches Zentrum City of Hope ist der Abschluss für 21. September 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 7. November 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.
Offizieller Titel
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
Erkrankungen
Neoplasma der hämatopoetischen und lymphoiden ZellenBösartige solide NeoplasiePrädiabetesWeitere Studien-IDs
- 20676
- NCI-2021-02807 (Registerkennung) (CTRP (Clinical Trial Reporting Program))
- 20676 (Andere Kennung) (City of Hope Medical Center)
- P30CA033572 (Zuwendung/Vertrag der US-NIH)
NCT-Nummer
Studienbeginn (tatsächlich)
2022-06-23
Zuletzt aktualisiert
2025-11-07
Studienende (vorauss.)
2026-09-21
Geplante Rekrutierung
20
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Aktiv, nicht rekrutierend
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Aktives VergleichspräparatArm I (home exercise) Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks. | Bewegungsintervention Complete home exercise |
ExperimentellArm II (home exercise, nicotinamide riboside) Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks. | Bewegungsintervention Complete home exercise Nicotinamide Riboside Given PO |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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
Medizinisches Zentrum City of Hope344 aktive klinische Studien zum ErkundenNationales Krebsinstitut, USA3028 aktive klinische Studien zum ErkundenKeine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern
California
City of Hope Medical Center, Duarte, California, 91010, United States