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

Sponsor

Hospital General de Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT05059847

Collaborator

(none)

114

Enrollment

Location

Arms

20.4

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia, Adult B-Cell	Other: Training	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Clinical randomized single blinded trialClinical randomized single blinded trial

Masking:

Single (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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 6, 2021

Anticipated Primary Completion Date :

Jan 13, 2023

Anticipated Study Completion Date :

May 19, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Active Comparator: 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.	Other: Training Training routine assigned by randomized chart
Experimental: 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.	Other: Training Training routine assigned by randomized chart

Arm

Intervention/Treatment

No Intervention: 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.

Active Comparator: 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.

Other: Training

Training routine assigned by randomized chart

Experimental: 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.

Other: Training

Training routine assigned by randomized chart

Outcome Measures

Primary Outcome Measures

Interleukin 15 [3 months]
Pro-inflammatory cytokine concentration, measured through peripheral blood
Neutrophils count [3 months]
Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle
Luekocytes count [3 months]
Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle
Platelets count [3 months]
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Hemoglobin count [3 months]
Number of hemoglobin found in peripheral blood at the end of each chemotherapy cycle
Functional Assessment of Cancer Therapy- Leukemia [3 months]
Psychological test that evaluates quality of life from four different areas: functional, emotional, social and physical wellness.
Blasts in marrow [3 months]
Presence of more than 20% of blasts in bone marrow after each chemotherapy cycle.

Secondary Outcome Measures

Complications during hospital stay [1 month]
Presence or absence of complications during the hospital stay, for example: neutropenic fever, infections, severe mucositis and/or cardiotoxicity.
Admission to ICU [3 months]
Admission to ICU during the protocol
Hospital Stay [1 month]
Measurement of days of hospital stay
Hospital Discharge [3 months]
The event in which patient is dishcarge from Hopital stay,

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

All

Accepts 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