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

NCT05059847 | Unknown DMC

• 1 other identifier: HGMDI/21/204/03/46
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Lymphoblastic Leukemia, Adult B-Cell

Keywords

Acute lymphoblastic leukemia; Interleukine-15; Cross-training; Body Composition; Physical performance

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (4)

• Complications during hospital stay

  1 month

• Admission to ICU

  3 months

• Hospital Stay

  1 month

• Hospital Discharge

  3 months

Study Arms (3)

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.

Other: Training

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.

Other: Training

Interventions

Training OTHER

Training routine assigned by randomized chart

Cross-training Group; Resistance Training Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General de Mexico: lead

Study Sites (1)

Hospital General de México "Dr. Eduardo Liceaga"

Mexico City, 06720, Mexico

RECRUITING

Related Publications (3)

• 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.

  PMID: 27742477 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.

  PMID: 26350143 BACKGROUND

• 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.

  PMID: 32580035 RESULT

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Adolfo Martinez Tovar, PhD

  Hospital General de Mexico

  STUDY DIRECTOR

Central Study Contacts

Christian O Ramos Peñafiel, PhD

CONTACT

+52 55 27892000; leukemiachop@hotmail.com

Adan G Gallardo Rodriguez, MSc

CONTACT

+52 55 27892000; nutriologo.agallardo8@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Clinical randomized single blinded trial

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 28, 2021
• Study Start: September 6, 2021
• Primary Completion: January 13, 2023
• Study Completion: May 19, 2023
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)