Impact of Cross-training on Induction Treatment Response in Acute Lymphoblastic Leukemia Adults
- Conditions
- Acute Lymphoblastic Leukemia, Adult B-Cell
- Interventions
- Other: Training
- Registration Number
- NCT05059847
- Lead Sponsor
- Hospital General de Mexico
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 114
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Resistance Training Group Training 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. Cross-training Group Training 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.
- Primary Outcome Measures
Name Time Method Platelets count 3 months Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Functional Assessment of Cancer Therapy- Leukemia 3 months Psychological test that evaluates quality of life from four different areas: functional, emotional, social and physical wellness.
Luekocytes count 3 months Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle
Hemoglobin count 3 months Number of hemoglobin found in peripheral blood at the end of each chemotherapy cycle
Interleukin 15 3 months Pro-inflammatory cytokine concentration, measured through peripheral blood
Neutrophils count 3 months Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle
Blasts in marrow 3 months Presence of more than 20% of blasts in bone marrow after each chemotherapy cycle.
- Secondary Outcome Measures
Name Time Method Hospital Discharge 3 months The event in which patient is dishcarge from Hopital stay,
Admission to ICU 3 months Admission to ICU during the protocol
Complications during hospital stay 1 month Presence or absence of complications during the hospital stay, for example: neutropenic fever, infections, severe mucositis and/or cardiotoxicity.
Hospital Stay 1 month Measurement of days of hospital stay
Trial Locations
- Locations (1)
Hospital General de México "Dr. Eduardo Liceaga"
🇲🇽Mexico City, Mexico