Nutrition and Exercise to Optimize Muscle and Adiposity in Adults With ALL: NEOMA ALL Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Chicago
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Feasibility of nutrition and exercise intervention
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •New Diagnosis of Philadelphia Chromosome Negative B-ALL
- •Receiving intensive pediatric-inspired induction chemotherapy
Exclusion Criteria
- •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
Arms & Interventions
Nutrition and Exercise interventions
Participants will receive an exercise and nutrition (diet) intervention while hospitalized for routine treatment for their ALL.
Intervention: Nutrition Intervention (Behavioral)
Nutrition and Exercise interventions
Participants will receive an exercise and nutrition (diet) intervention while hospitalized for routine treatment for their ALL.
Intervention: Exercise intervention (Behavioral)
Outcomes
Primary Outcomes
Feasibility of nutrition and exercise intervention
Time Frame: End of study recruitment (approximately 1 year)
Percentage of eligible patients that consent to trial.
Secondary Outcomes
- Adherence to dietary intervention(22 days)
- Adherence to exercise intervention(22 days)
- Usability of interventions(22 days)
- Body composition changes - Visceral Adiposity(22 days)
- Body composition changes - Sarcopenia (SMI)(22 days)
- Impact on minimal residual disease (MRD)(22 days)
- Impact on Treatment toxicities(22 days)
- Changes to the Host Metabolome(22 days)