Acute Lymphoblastic Leukemia, Adult B-CellNCT05059847
Impact of Cross-training on Induction Treatment Response in Acute Lymphoblastic Leukemia Adults
A study testing Training in people with Acute Lymphoblastic Leukemia, Adult B-Cell, run by Hospital General de Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Adult B-Cell
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteMexico
- Study dates
- 6 Sep 2021to 19 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de México "Dr. Eduardo Liceaga"
Mexico City, 06720
Christian O Ramos-Peñafiel, MD, PhD, +52 55 2789 2000 ext. 2020, leukemiachop@hotmail.com
Adan G Gallardo-Rodriguez, MSc, +52 55 2789 2000 ext. 2020, nutriologo.agallardo8@gmail.com
About this study
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
Read the 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
- Being tested
- Training
- Keywords
- Acute lymphoblastic leukemia, Interleukine-15, Cross-training, Body Composition, Physical performance
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Training routine assigned by randomized chart
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin 15
Pro-inflammatory cytokine concentration, measured through peripheral blood
Measured: 3 months
Neutrophils count
Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle
Measured: 3 months
Luekocytes count
Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle
Measured: 3 months
Platelets count
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Measured: 3 months
Hemoglobin count
Number of hemoglobin found in peripheral blood at the end of each chemotherapy cycle
Measured: 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.
Measured: 3 months
Blasts in marrow
Presence of more than 20% of blasts in bone marrow after each chemotherapy cycle.
Measured: 3 months
Secondary outcomes (4)
Complications during hospital stay
Presence or absence of complications during the hospital stay, for example: neutropenic fever, infections, severe mucositis and/or cardiotoxicity.
Measured: 1 month
Admission to ICU
Admission to ICU during the protocol
Measured: 3 months
Hospital Stay
Measurement of days of hospital stay
Measured: 1 month
Hospital Discharge
The event in which patient is dishcarge from Hopital stay,
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start6 Sep 2021
- Primary completion13 Jan 2023 (estimated)
- Study completion19 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia, Adult B-CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical randomized single blinded trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Christian Omar Ramos-Peñafiel, MD, PhD, Hospital General de Mexico
- Investigators
- Adolfo Martinez Tovar, PhD, Study director, Hospital General de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059847
- Sponsor's protocol ID
- HGMDI/21/204/03/46
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participants and its information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws
Publications
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.
PubMed 27742477Alibhai 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.
PubMed 26350143Coombs 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.
PubMed 32580035
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cross-training on Induction Treatment Response in Acute Lymphoblastic Leukemia Adults
- ClinicalTrials.gov ID
- NCT05059847
- Acronym / sponsor ID
- HGMDI/21/204/03/46
- Keywords
- Acute lymphoblastic leukemia, Interleukine-15, Cross-training, Body Composition, Physical performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 13 Jan 2023 (estimated)
- Study completion
- 19 May 2023 (estimated)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Clinical randomized single blinded trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: TrainingEach 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. |
| Cross-training Group | Experimental | Other: TrainingEach 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingTraining routine assigned by randomized chart | Other | Cross-training Group, Resistance Training Group |
Primary outcome
Interleukin 15
Time frame: 3 months
Pro-inflammatory cytokine concentration, measured through peripheral blood
Neutrophils count
Time frame: 3 months
Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle
Luekocytes count
Time frame: 3 months
Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle
Platelets count
Time frame: 3 months
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Hemoglobin count
Time frame: 3 months
Number of hemoglobin found in peripheral blood at the end of each chemotherapy cycle
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.
Blasts in marrow
Time frame: 3 months
Presence of more than 20% of blasts in bone marrow after each chemotherapy cycle.
4 secondary outcomes
Complications during hospital stay
Time frame: 1 month
Admission to ICU
Time frame: 3 months
Hospital Stay
Time frame: 1 month
Hospital Discharge
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 27742477Gomez-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.
- Background: PubMed 26350143Alibhai 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 publication: PubMed 32580035Coombs 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.
- Individual participant dataSharing planned: No. All participants and its information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adolfo Martinez Tovar, PhD study director
Hospital General de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Acute Lymphoblastic Leukemia, Adult B-Cell, run by Hospital General de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian O Ramos Peñafiel, PhD (+52 55 27892000 ext. 2020, leukemiachop@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin 15 (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05059847, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.