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

Acute Lymphoblastic Leukemia, Adult B-Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05059847
• Other study ID #: HGMDI/21/204/03/46
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: May 19, 2023

Study information

• Verified date: September 2021
• Source: Hospital General de Mexico
• Contact: Christian O Ramos Peñafiel, PhD
• Phone: +52 55 27892000
• Email: leukemiachop[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: May 19, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, Adult B-Cell
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Training
Training routine assigned by randomized chart

Locations

Country	Name	City	State
Mexico	Hospital General de México "Dr. Eduardo Liceaga"	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

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. pii: S0145-2126(15)30365-9. doi: 10.1016/j.leukres.2015.08.012. [Epub ahead of print] — View 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 — View Citation

Gómez-Almaguer D, Marcos-Ramírez ER, Montaño-Figueroa EH, Ruiz-Argüelles GJ, Best-Aguilera CR, López-Sánchez MD, Barrera-Chairez E, López-Arrollo JL, Ramos-Peñafiel CO, León-Peña A, González-López EE, Rivas-García PE, Tellez-Hinojosa CA, Gómez-De León A, Jaime-Pérez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin 15	Pro-inflammatory cytokine concentration, measured through peripheral blood	3 months
Primary	Neutrophils count	Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle	3 months
Primary	Luekocytes count	Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle	3 months
Primary	Platelets count	Number of platelets found in peripheral blood at the end of each chemotherapy cycle	3 months
Primary	Hemoglobin count	Number of hemoglobin found in peripheral blood at the end of each chemotherapy cycle	3 months
Primary	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
Primary	Blasts in marrow	Presence of more than 20% of blasts in bone marrow after each chemotherapy cycle.	3 months
Secondary	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
Secondary	Admission to ICU	Admission to ICU during the protocol	3 months
Secondary	Hospital Stay	Measurement of days of hospital stay	1 month
Secondary	Hospital Discharge	The event in which patient is dishcarge from Hopital stay,	3 months