Clinical trial NCT05059847: Impact of Cross-training on Induction Treatment Response in Acute Lymphoblastic Leukemia Adults
Official title: Impact of Cross-training on Induction Treatment Response in Acute Lymphoblastic Leukemia Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Lymphoblastic Leukemia, Adult B-Cell
Keywords: Acute lymphoblastic leukemia
Interleukine-15
Cross-training
Body Composition
Physical performance
Lead sponsor: Hospital General de Mexico
Sponsor class: OTHER_GOV
First posted: 2021-09-28
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical randomized single blinded trial
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Interleukin 15
timeFrame: 3 months
measure: Neutrophils count
timeFrame: 3 months
measure: Luekocytes count
timeFrame: 3 months
measure: Platelets count
timeFrame: 3 months
measure: Hemoglobin count
timeFrame: 3 months
measure: Functional Assessment of Cancer Therapy- Leukemia
timeFrame: 3 months
measure: Blasts in marrow
timeFrame: 3 months
Secondary outcomes:
measure: Complications during hospital stay
timeFrame: 1 month
measure: Admission to ICU
timeFrame: 3 months
measure: Hospital Stay
timeFrame: 1 month
measure: Hospital Discharge
timeFrame: 3 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General de México "Dr. Eduardo Liceaga"
Study officials:
affiliation: Hospital General de Mexico
name: Adolfo Martinez Tovar, PhD
role: STUDY_DIRECTOR
References:
citation: Gomez-Almaguer D, Marcos-Ramirez ER, Montano-Figueroa EH, Ruiz-Arguelles GJ, Best-Aguilera CR, Lopez-Sanchez MD, Barrera-Chairez E, Lopez-Arrollo JL, Ramos-Penafiel CO, Leon-Pena A, Gonzalez-Lopez EE, Rivas-Garcia PE, Tellez-Hinojosa CA, Gomez-De Leon A, Jaime-Perez JC. Acute Leukemia Characteristics are Different Around the World: the Mexican Perspective. Clin Lymphoma Myeloma Leuk. 2017 Jan;17(1):46-51. doi: 10.1016/j.clml.2016.09.003. Epub 2016 Sep 17.
citation: Alibhai SM, Durbano S, Breunis H, Brandwein JM, Timilshina N, Tomlinson GA, Oh PI, Culos-Reed SN. A phase II exercise randomized controlled trial for patients with acute myeloid leukemia undergoing induction chemotherapy. Leuk Res. 2015 Aug 28:S0145-2126(15)30365-9. doi: 10.1016/j.leukres.2015.08.012. Online ahead of print.
citation: Coombs A, Schilperoort H, Sargent B. The effect of exercise and motor interventions on physical activity and motor outcomes during and after medical intervention for children and adolescents with acute lymphoblastic leukemia: A systematic review. Crit Rev Oncol Hematol. 2020 Aug;152:103004. doi: 10.1016/j.critrevonc.2020.103004. Epub 2020 May 27.