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

Hospital General de Mexico

Status: Unknown

Conditions: Acute Lymphoblastic Leukemia, Adult B-Cell

Treatments: Other: Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05059847

HGMDI/21/204/03/46

Details and patient eligibility

About

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

Full 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

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 3 patient groups

Standard Care Group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Training

Cross-training Group

Experimental group

Description:

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.

Treatment:

Other: Training