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

September 16, 2021 updated by: Christian Omar Ramos-Peñafiel, MD, PhD, Hospital General de Mexico
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

Study Overview

Status

Recruiting

Conditions

Intervention / 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

Study Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 06720
        • Recruiting
        • Hospital General de México "Dr. Eduardo Liceaga"
        • Contact:
        • Sub-Investigator:
          • Vanessa Fuchs Tarlovsky, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General de Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2021

Primary Completion (Anticipated)

January 13, 2023

Study Completion (Anticipated)

May 19, 2023

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 28, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGMDI/21/204/03/46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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