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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care Group | No Intervention | 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. | |
| Resistance Training Group | Active Comparator | 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. |
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| Cross-training Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training | Other | Training routine assigned by randomized chart |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian O Ramos Peñafiel, PhD | Contact | +52 55 27892000 | 2020 | leukemiachop@hotmail.com |
| Adan G Gallardo Rodriguez, MSc | Contact | +52 55 27892000 | 2020 | nutriologo.agallardo8@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Adolfo Martinez Tovar, PhD | Hospital General de Mexico | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de México "Dr. Eduardo Liceaga" | Recruiting | Mexico City | 06720 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27742477 | Background | 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. | |
| 26350143 |
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All participants and its information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Clinical randomized single blinded trial
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The masking of the study will be for the principal investigator, only knowing the maneuver person in charge of the routine and the patient. The patients who will practice the exercise intervention will be carry out in certain space and time that does not interfere with the medical intervention and in which the treating medical personnel will not be present.
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 |
| Background |
| 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. |
| 32580035 | Result | 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. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |