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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:
All subjects will be provided with a wearable electronic activity monitor (FitBit®) to assist in recording activity levels in minutes of activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition and Exercise interventions | Experimental | Participants will receive an exercise and nutrition (diet) intervention while hospitalized for routine treatment for their ALL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of nutrition and exercise intervention | Percentage of eligible patients that consent to trial. | End of study recruitment (approximately 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Intake | Contact | 1-855-702-8222 | cancerclinicaltrials@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wendy Stock | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine Comprehensive Cancer Center | Recruiting | Chicago | Illinois | 60637 | United States |
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| Exercise intervention | Behavioral | 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. |
|
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 |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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