Study of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
New Diagnosis of Philadelphia Chromosome Negative B-ALL
Receiving intensive pediatric-inspired induction chemotherapy
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Nutrition and Exercise interventionsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Feasibility of nutrition and exercise intervention
Percentage of eligible patients that consent to trial.
Time frame
End of study recruitment (approximately 1 year)Secondary outcomes
1
Adherence to dietary intervention
Percentage of participants that are "adherent", defined as \>75% of the patient's dietary assessments consistent with the prescribed diet.
Time frame
22 days2
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.
Time frame
22 days3
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.
Time frame
22 days4
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
Time frame
22 daysSponsors and contacts
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Source ClinicalTrials.gov