Clinical trial NCT06654206: Effects of a Strength Physical Exercise Program in Chronic Lymphocytic Leukemia Patients
Official title: Effects of a Strength Physical Exercise Program in Chronic Lymphocytic Leukemia Patients on Quality of Life, Mental Health, and Frailty.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Chronic Lymphocytic Leukemia
Exercise
Keywords: Exercise
Resistance
Chronic Lymphocytic Leukemia
Physiotherapy
Lead sponsor: University of Salamanca
Sponsor class: OTHER
Collaborators: name: Colegio Profesional de Fisioterapeutas de Castilla y León
First posted: 2024-10-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blind, randomized controlled clinical trial with two parallel groups, in which patients diagnosed with Chronic Lymphocytic Leukemia (CLL) and undergoing active treatment will be recruited. Study participants will be assigned to one of two arms of the study: 1) Supervised Therapeutic Strength Exercise Intervention Group (GI); 2) Control Group without Supervised Exercise (GC). The study will last for 3 months. There will be 2 evaluation visits: one prior to the intervention (initial visit) and one at the end of the intervention (final visit). The intervention period will last for 8 weeks.

The trial will be conducted following the CONSORT (Consolidated Standards of Reporting Trials) guidelines, and the current treatment protocol is described according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) recommendations.
Primary purpose: TREATMENT

Brief summary: Chronic lymphocytic leukemia (CLL) is a hematological neoplasm that primarily affects older individuals and is the most common type of leukemia in adults in Western countries. CLL mainly affects older adults, with an average age at diagnosis of around 70 years, and there is a slightly higher risk in men compared to women. It is characterized by the proliferation of clonal B lymphocytes in peripheral blood, bone marrow, and lymphoid organs. Although CLL has a relatively slow progression in many cases, patients may experience chronic fatigue, muscle weakness, functional impairment, and psychological disorders, such as anxiety and depression, which significantly affect their quality of life.

In this context, it has been shown that physical exercise, especially strength training, can considerably improve physical and psychological conditions in oncology populations, such as those with breast cancer and colorectal cancer, as well as in older adults, where the benefits of resistance training are widely recognized. These benefits include increased muscle strength, reduced fatigue, improved functional abilities, psychological well-being, and overall quality of life. Furthermore, there is evidence that exercise can reduce systemic inflammatory markers, such as C-reactive protein (CRP), and improve lipid profiles by lowering total cholesterol and triglycerides, which is crucial for cancer patients at risk of cardiovascular diseases.

Detailed description: Current research on the effects of physical exercise in patients with CLL is limited. While some studies suggest that cancer patients may benefit from physical exercise, most research has focused on other types of cancer, such as breast, lung, or colorectal cancer. In the case of patients with CLL, in addition to functional and psychological issues, they often experience chronic inflammation and alterations in lipid profiles, which can increase the risk of cardiovascular comorbidities.

Inflammatory markers, such as C-reactive protein (CRP) and pro-inflammatory cytokines (IL-6, TNF-α), are common in patients with CLL, and it has been suggested that modulating these markers through exercise may help control systemic inflammation. Strength training, in particular, could be beneficial for improving the inflammatory and lipid profiles in these patients, although this has not been thoroughly evaluated in this population.

Regarding mental health, studies have reported that patients with CLL experience high levels of anxiety and depression, which significantly deteriorate their quality of life. In other oncology populations, exercise has proven effective in reducing these symptoms and improving overall well-being. However, it has not been sufficiently studied whether these effects can be replicated in patients with CLL, representing a gap in the current literature.

Finally, the loss of muscle strength, a key indicator in the diagnosis of sarcopenia according to the diagnostic algorithm proposed by the European Working Group on Sarcopenia in Older People in 2019 (EWGSOP2), should be considered another common issue in patients with CLL, due to both the average age of the patients (70 years) and the disease itself or the side effects of treatment. Although it has been shown that physical exercise in general, and strength exercise in particular, can improve muscle strength and functional capacity in older adults and cancer patients, studies evaluating these effects in patients with CLL are lacking. Assessing how a strength training program can influence functional recovery and improve the quality of life of these patients is crucial for their clinical management.

Eligibility criteria: Inclusion Criteria

* Participants diagnosed with CLL or Small Lymphocytic Lymphoma (SLL) undergoing active treatment.
* Participants who have not engaged in regular physical activity in the past 8 weeks.
* Performance Status (ECOG) 0-1.
* Signed informed consent.

Exclusion Criteria

* The presence of any medical contraindications to physical exercise, such as severe musculoskeletal disorders, serious cardiovascular diseases, bone metastases, or other conditions as determined by a healthcare professional.
* Participants unable to complete the initial evaluation tests or who have difficulty performing basic exercises.
* Other circumstances, as determined by the researchers, that may interfere with the study's objectives or development.

Participants will be discontinued if they meet any of the following:

* Negative developments or progression of the tumor process.
* Severe adverse events related to exercise.
* Voluntary withdrawal from the intervention.
* New medical contraindications that prevent safe participation.
* Non-adherence to the intervention protocol that compromises study integrity.

Primary outcomes:
measure: Frailty
timeFrame: 8 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: From enrollment to the end of the treatment, 8 weeks.
measure: Anxiety and depression
timeFrame: From enrollment to the end of the treatment, 8 weeks.
measure: Fatigue
timeFrame: From enrollment to the end of the treatment, 8 weeks.
measure: Sleep quality
timeFrame: From enrollment to the end of the treatment, 8 weeks.
measure: Muscle strength
timeFrame: From enrollment to the end of the treatment, 8 weeks.
measure: Body composition
timeFrame: From enrollment to the end of the treatment, 8 weeks.
measure: Physical activity level
timeFrame: From enrollment to the end of the treatment, 8 weeks.
measure: Physical performance
timeFrame: 8 weeks
measure: Blood biomarker
timeFrame: From enrollment to the end of the treatment, 8 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: University of Salamanca
name: Carlos Martin Sanchez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown JC, Spielmann G, Yang S, Compton SLE, Jones LW, Irwin ML, Ligibel JA, Meyerhardt JA. Effects of exercise or metformin on myokine concentrations in patients with breast and colorectal cancer: A phase II multi-centre factorial randomized trial. J Cachexia Sarcopenia Muscle. 2024 Aug;15(4):1520-1527. doi: 10.1002/jcsm.13509. Epub 2024 Jun 18.