search
Back to results

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

Primary Purpose

Acute Lymphoblastic Leukemia, Adult B-Cell

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Training
Sponsored by
Hospital General de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia, Adult B-Cell focused on measuring Acute lymphoblastic leukemia, Interleukine-15, Cross-training, Body Composition, Physical performance

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital General de México "Dr. Eduardo Liceaga"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Standard Care Group

Resistance Training Group

Cross-training Group

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Interleukin 15
Pro-inflammatory cytokine concentration, measured through peripheral blood
Neutrophils count
Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle
Luekocytes count
Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle
Platelets count
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Hemoglobin count
Number of hemoglobin found in peripheral blood at the end of each chemotherapy cycle
Functional Assessment of Cancer Therapy- Leukemia
Psychological test that evaluates quality of life from four different areas: functional, emotional, social and physical wellness.
Blasts in marrow
Presence of more than 20% of blasts in bone marrow after each chemotherapy cycle.

Secondary Outcome Measures

Complications during hospital stay
Presence or absence of complications during the hospital stay, for example: neutropenic fever, infections, severe mucositis and/or cardiotoxicity.
Admission to ICU
Admission to ICU during the protocol
Hospital Stay
Measurement of days of hospital stay
Hospital Discharge
The event in which patient is dishcarge from Hopital stay,

Full Information

First Posted
September 7, 2021
Last Updated
September 16, 2021
Sponsor
Hospital General de Mexico
search

1. Study Identification

Unique Protocol Identification Number
NCT05059847
Brief Title
Impact of Cross-training on Induction Treatment Response in Acute Lymphoblastic Leukemia Adults
Official Title
Impact of Cross-training on Induction Treatment Response in Acute Lymphoblastic Leukemia Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
January 13, 2023 (Anticipated)
Study Completion Date
May 19, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Adult B-Cell
Keywords
Acute lymphoblastic leukemia, Interleukine-15, Cross-training, Body Composition, Physical performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical randomized single blinded trial
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care Group
Arm Type
No Intervention
Arm 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.
Arm Title
Resistance Training Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Cross-training Group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Training
Intervention Description
Training routine assigned by randomized chart
Primary Outcome Measure Information:
Title
Interleukin 15
Description
Pro-inflammatory cytokine concentration, measured through peripheral blood
Time Frame
3 months
Title
Neutrophils count
Description
Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle
Time Frame
3 months
Title
Luekocytes count
Description
Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle
Time Frame
3 months
Title
Platelets count
Description
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Time Frame
3 months
Title
Hemoglobin count
Description
Number of hemoglobin found in peripheral blood at the end of each chemotherapy cycle
Time Frame
3 months
Title
Functional Assessment of Cancer Therapy- Leukemia
Description
Psychological test that evaluates quality of life from four different areas: functional, emotional, social and physical wellness.
Time Frame
3 months
Title
Blasts in marrow
Description
Presence of more than 20% of blasts in bone marrow after each chemotherapy cycle.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complications during hospital stay
Description
Presence or absence of complications during the hospital stay, for example: neutropenic fever, infections, severe mucositis and/or cardiotoxicity.
Time Frame
1 month
Title
Admission to ICU
Description
Admission to ICU during the protocol
Time Frame
3 months
Title
Hospital Stay
Description
Measurement of days of hospital stay
Time Frame
1 month
Title
Hospital Discharge
Description
The event in which patient is dishcarge from Hopital stay,
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian O Ramos Peñafiel, PhD
Phone
+52 55 27892000
Ext
2020
Email
leukemiachop@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adan G Gallardo Rodriguez, MSc
Phone
+52 55 27892000
Ext
2020
Email
nutriologo.agallardo8@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adolfo Martinez Tovar, PhD
Organizational Affiliation
Hospital General de Mexico
Official's Role
Study Director
Facility Information:
Facility Name
Hospital General de México "Dr. Eduardo Liceaga"
City
Mexico City
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian O Ramos-Peñafiel, MD, PhD
Phone
+52 55 2789 2000
Ext
2020
Email
leukemiachop@hotmail.com
First Name & Middle Initial & Last Name & Degree
Adan G Gallardo-Rodriguez, MSc
Phone
+52 55 2789 2000
Ext
2020
Email
nutriologo.agallardo8@gmail.com
First Name & Middle Initial & Last Name & Degree
Vanessa Fuchs Tarlovsky, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All participants and its information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws
Citations:
PubMed Identifier
27742477
Citation
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.
Results Reference
background
PubMed Identifier
26350143
Citation
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.
Results Reference
background
PubMed Identifier
32580035
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 Oncol Hematol. 2020 Aug;152:103004. doi: 10.1016/j.critrevonc.2020.103004. Epub 2020 May 27.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs