Impact of Cross-training on Induction Treatment Response in Acute Lymphoblastic Leukemia Adults

Study Overview
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Brief Summary
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Despite advances in the treatment of acute lymphoblastic leukemia, the prognosis in adults is still poor, largely due to the resistance of treatment at diagnosis or early relapse. Among the strategies associated with the treatment of Acute Lymphoblastic Leukemia is rehabilitation and physical medicine in order to improve the quality of life, body composition, fitness, strength and improve the attachment and acceptance of their treatment

Detailed Description
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Previous evidence had shown that among the beneficial effects of an exercise intervention in cancer is the reduction of adverse events associated with treatment, such as nausea and fatigue. Also, the overexpression of Interleukin-15 in cancer is related to a poor prognosis, biologically the implementation of a cross-training exercise routine can function as a regulatory pathway for its expression due to its consumption at muscular level. Finally, the time to consider a relapse with a very poor prognosis is during first three months of treatment, so implementation of an exercise strategy during this period could reduce the proportion of early relapses mediated by Interleukin-15 expression

Official Title
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Impact of Cross-training on Induction Treatment Response in Acute Lymphoblastic Leukemia Adults

Conditions
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Acute Lymphoblastic Leukemia, Adult B-Cell

Intervention / Treatment
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* Other: Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to walk without support. Life expectancy greater than 7 days Previous authorization of treating hematologist for participation Acceptance and signing of informed consent form Exclusion Criteria: Patients with neutropenia, infections and / or bleeding on admission to hospitalization. Patients that are unable to perform physical activity. Central nervous system diseases that make movement impossible. Cardiac function alterations assessed by electrocardiogram and echocardiogram Patients in relapse Patients referred from another hospital and who are been attended in our hospital

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinical randomized single blinded trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care Group<br>Each patient will receive the standard pharmacological treatment for patients with Acute Lymphoblastic Leukemia based on 3 cycles of chemotherapy (21 days duration per cycle); plus the World Health Organization recommendation that indicates at least 150 min a week of moderate physical activity, equivalent to walking 30 minutes a day for 5 days at an intensity between 60 and 70% of your maximum heart rate. | |
| Active Comparator: Resistance Training Group<br>Each patient will receive the standard pharmacological treatment for patients with Acute Lymphoblastic Leukemia based on 3 cycles of chemotherapy (21 days duration per cycle); plus a resistance exercise routine using weights. An individualized program with exercises supervised by a trainer and basic medical team will be developed for each patient during their hospital stay. Each training routine will have a monthly exercise progression based on intensity, frequency and / or duration. | Other: Training<br>* Training routine assigned by randomized chart<br>|
| Experimental: Cross-training Group<br>Each patient will receive the standard pharmacological treatment for patients with Acute Lymphoblastic Leukemia based on 3 cycles of chemotherapy (21 days duration per cycle); plus a cross-training routine using implements without any extra weight to improve stability, joint mobility and general strength of the body. An individualized program with exercises supervised by a trainer and basic medical team will be developed for each patient during their hospital stay. Each training routine will have a monthly exercise progression based on intensity, frequency and / or duration. | Other: Training<br>* Training routine assigned by randomized chart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin 15 | Pro-inflammatory cytokine concentration, measured through peripheral blood | 3 months | 
| Neutrophils count | Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle | 3 months | 
| Luekocytes count | Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle | 3 months | 
| Platelets count | Number of platelets found in peripheral blood at the end of each chemotherapy cycle | 3 months | 
| Hemoglobin count | Number of hemoglobin found in peripheral blood at the end of each chemotherapy cycle | 3 months | 
| Functional Assessment of Cancer Therapy- Leukemia | Psychological test that evaluates quality of life from four different areas: functional, emotional, social and physical wellness. | 3 months | 
| Blasts in marrow | Presence of more than 20% of blasts in bone marrow after each chemotherapy cycle. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications during hospital stay | Presence or absence of complications during the hospital stay, for example: neutropenic fever, infections, severe mucositis and/or cardiotoxicity. | 1 month | 
| Admission to ICU | Admission to ICU during the protocol | 3 months | 
| Hospital Stay | Measurement of days of hospital stay | 1 month | 
| Hospital Discharge | The event in which patient is dishcarge from Hopital stay, | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute lymphoblastic leukemia, Interleukine-15, Cross-training, Body Composition, Physical performance