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Universität von ChicagoStudy of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL) (NEOMA ALL)
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06785324 (NEOMA ALL) ist eine interventionsstudie zur Untersuchung von Philadelphia Chromosome Negative, B Cell Acute Lymphoblastic Leukemia (B-all), B-ALL und hat den Status offene rekrutierung. Die Studie startete am 12. Mai 2025 und soll 20 Teilnehmer aufnehmen. Durchgeführt von Universität von Chicago ist der Abschluss für 6. November 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. Juni 2025 aktualisiert.
Kurzbeschreibung
This clinical trial aims to assess the effect of nutrition and exercise on muscle and adiposity in adults with Philadelphia Chromosome (Ph) Negative B-ALL undergoing inpatient induction therapy.
Participants will take part in 2 different interventions:
- Nutrition Intervention
- Physical Exercise Intervention
All subjects will be provided with a wearable electronic activity monitor (FitBit®) to assist in recording activity levels in minutes of activity.
Offizieller Titel
Nutrition and Exercise to Optimize Muscle and Adiposity in Adults With ALL: NEOMA ALL Trial
Erkrankungen
Philadelphia Chromosome NegativeB Cell Acute Lymphoblastic Leukemia (B-all)B-ALLWeitere Studien-IDs
- NEOMA ALL
- IRB24-1500
NCT-Nummer
Studienbeginn (tatsächlich)
2025-05-12
Zuletzt aktualisiert
2025-06-19
Studienende (vorauss.)
2027-11-06
Geplante Rekrutierung
20
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellNutrition and Exercise interventions Participants will receive an exercise and nutrition (diet) intervention while hospitalized for routine treatment for their ALL. | Ernährungsintervention The nutrition intervention will target a 10% caloric deficit calculated from each patient's Basal Metabolic Rate (WHO/Schofield) utilizing a high protein (\>25%), low fat (\<25%), low glycemic index/high fiber (45-55%) diet.
The study registered dietician (RD) will meet with the patient on day of enrollment to go over the "menu" of dietary options and will re-assess the patient every two days (excluding weekends) for adherence.
My Plate (USDA) will control portion size and eating habits. Bewegungsintervention The exercise intervention will target 200 minutes of "moderate" physical activity weekly, as defined by Metabolic Equivalents (METs) of 3-6, made up of aerobic and resistance training activities tailored to the patient's preference by working with the study physical therapist (PT).
Physical Therapist to evaluate patient every 48 hours, excluding weekends. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Feasibility of nutrition and exercise intervention | Percentage of eligible patients that consent to trial. | End of study recruitment (approximately 1 year) |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Adherence to dietary intervention | Percentage of participants that are "adherent", defined as \>75% of the patient's dietary assessments consistent with the prescribed diet. | 22 days |
Adherence to exercise intervention | Percentage of participants able to meet the exercise goal in 2 out of 3 weeks of induction therapy or 66% of their weeks of inpatient admission if admitted for more than 3 weeks. | 22 days |
Usability of interventions | To assess intervention usability, a 10-item questionnaire, the System Usability Scale Questionnaire, will be administered to each patient postintervention. This instrument rates responses from "strongly agree" to "strongly disagree". A score \>68 is considered of acceptable usability. | 22 days |
Body composition changes - Visceral Adiposity | Percent change in Visceral Adiposity from baseline to day 22 on study will be described. CT measurements of height-adjusted lumber adiposity area (VAT) are calculated from routine contrast and non-contrast CT scans of chest and abdomen | 22 days |
Body composition changes - Sarcopenia (SMI) | Percent change in sarcopenia score from baseline to day 22 on study will be described. Sarcopenia is loss of skeletal muscle mass and function associated with aging and will be calculated as mg/m2 measurements of skeletal muscle cross-sectional area, index, and radiation attenuation utilizing clinical computed tomography (CT) scans. The lower the value the worse the outcome. | 22 days |
Impact on minimal residual disease (MRD) | Number of participants that are MRD positive at end of induction therapy | 22 days |
Impact on Treatment toxicities | Number of participants that experience experience grade 3-4 hyperglycemia and hepatoxicity during induction. Adverse Events will be graded using Common Terminology Criteria for Adverse Events (CTCAE) v5 criteria. | 22 days |
Changes to the Host Metabolome | Assessment of changes to the host metabolome throughout the intervention on daily serum samples (excluding weekends and holidays) will be assess descriptively | 22 days |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- New Diagnosis of Philadelphia Chromosome Negative B-ALL
- Receiving intensive pediatric-inspired induction chemotherapy
- BMI ≤18.5 kg/m2 at time of diagnosis
- Unable to comply with both the recommended diet and exercise regimen as deemed by the research or treatment team
- Pregnant
Universität von Chicago563 aktive klinische Studien zum ErkundenZentrale Studienkontakte
Kontakt: Clinical Trials Intake, 1-855-702-8222, [email protected]
1 Studienstandorte in 1 Ländern
Illinois
University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, 60637, United States
Clinical Trials intake, Kontakt, 855-702-8222, [email protected]
Wendy Stock, Hauptprüfer
Offene Rekrutierung