Study of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL)
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- University of Chicago
- Study ID
- NCT06785324
- Status
- Recruiting
Conditions
- B Cell Acute Lymphoblastic Leukemia (B-ALL)
- B-ALL
- Philadelphia Chromosome Negative
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- Nutrition Intervention — BEHAVIORALThe 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.
- Exercise intervention — BEHAVIORALThe 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.
Study Details
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.
Key Dates
- Start date
- May 12, 2025
- Status verified
- Jun 2025
- Primary completion
- Nov 6, 2027
- Completion
- Nov 6, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Nutrition and Exercise interventionsParticipants will receive an exercise and nutrition (diet) intervention while hospitalized for routine treatment for their ALL.
Primary Outcome Measure
Feasibility of nutrition and exercise intervention [ Time Frame: End of study recruitment (approximately 1 year) ]
Central Contacts
- Clinical Trials Intake1-855-702-8222
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Chicago Medicine Comprehensive Cancer Center | Chicago | Illinois | 60637 | Wendy Stock (PRINCIPAL_INVESTIGATOR) |
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