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

NCT ID: NCT05059847

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-06

Study Completion Date

2023-05-19

Brief Summary

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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

Detailed Description

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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

Conditions

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Acute Lymphoblastic Leukemia, Adult B-Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Clinical randomized single blinded trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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Standard Care Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Resistance Training Group

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.

Group Type ACTIVE_COMPARATOR

Training

Intervention Type OTHER

Training routine assigned by randomized chart

Cross-training Group

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.

Group Type EXPERIMENTAL

Training

Intervention Type OTHER

Training routine assigned by randomized chart

Interventions

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Training

Training routine assigned by randomized chart

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General de Mexico

OTHER_GOV

Sponsor Role lead

Responsible Party

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Christian Omar Ramos-Peñafiel, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adolfo Martinez Tovar, PhD

Role: STUDY_DIRECTOR

Hospital General de Mexico

Locations

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Hospital General de México "Dr. Eduardo Liceaga"

Mexico City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Christian O Ramos Peñafiel, PhD

Role: CONTACT

+52 55 27892000 ext. 2020

Adan G Gallardo Rodriguez, MSc

Role: CONTACT

+52 55 27892000 ext. 2020

Facility Contacts

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Christian O Ramos-Peñafiel, MD, PhD

Role: primary

+52 55 2789 2000 ext. 2020

Adan G Gallardo-Rodriguez, MSc

Role: backup

+52 55 2789 2000 ext. 2020

References

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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.

Reference Type BACKGROUND
PMID: 27742477 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26350143 (View on PubMed)

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.

Reference Type RESULT
PMID: 32580035 (View on PubMed)

Other Identifiers

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HGMDI/21/204/03/46

Identifier Type: -

Identifier Source: org_study_id

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