Clinical trial NCT06660446: Exercise During Chemotherapy Treatment As Adjuvant Program in Patients with Lymphoma: EDONOLA Study.
Official title: Ejercicio Físico Durante El Tratamiento De Quimioterapia Como Programa Adyuvante En Pacientes Con Linfoma: Estudio EDONOLA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphoma
Keywords: Lymphoma
Physical Exercise
Fatigue
Cardiorespiratory capacity
Life Quality
Lead sponsor: Biogipuzkoa Health Research Institute
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In people diagnosed with lymphoma receiving immunochemotherapy treatment, a combined exercise intervention, as opposed to the general recommendations, will achieve: 1.Improve cardiorespiratory fitness, strength, psychological well-being and quality of life. //2.Reduce fatigue//3.Reduce frailty

There is an association between some biological biomarkers with physical capacity and frailty.

Detailed description: In this study, the effectiveness of an individualized adjuvant exercise program will be analyzed in a homogeneous population of people diagnosed with lymphoma in active treatment. Taking into account the limited scientific evidence that currently exists in people affected by lymphoma and active treatment, the study could be of great relevance when it comes to providing scientific evidence in this very little field studied. The study will try to respond to the evident need to focus the research area on supervised exercise in people with lymphoma in a way innovative, with the aim of generating new hypotheses that overcome existing limitations and facilitate the introduction of this type of interventions into the health system. The present study will also analyze the effect of exercise from a gender perspective, an aspect not systematically studied until now, providing a new vision on the baseline differences and after intervention of a program based on of sex.

The study will include adults with lymphoma with special focus on the subanalysis of the group of patients equal or more than 70 years old. The lymphoma unit of the Donostia University Hospital (HUD) is part of the Onkofrail project that analyzes the impact of a physical activity in older cancer patients. The Onkofrail study has included everything type of solid tumors and very diverse treatments, which is a limitation methodology that could condition the analysis of the results. Therefore, the need of proposing a new exercise project in a homogeneous population such as that of people with lymphoma, the most prevalent hemopathy in our environment, which has a great survival, but present important adverse effects secondary to treatment systemic. 30 people with lymphoma and treatment have been included in the Onkofrail study asset. The preliminary results of said pilot study have been used for the design of this new study, making adaptations, both in the recruitment time, as well as inclusion and exclusion criteria, which guarantee and optimize the correct research development.

Main objective:

The main objective is to assess whether a supervised (2 days/week) combined (resistance+aerobic interval training) exercise intervention, plus 2 days/week unsupervised for 20 weeks improves cardiorespiratory fitness (CRF) in people diagnosed with lymphoma undergoing chemotherapy, compared to a control group receiving only general recommendations.

Secondary objectives:

1. To estimate cardiorespiratory capacity (VO2peak) through a field test Modified Shuttle Walking Test (MSWT) and other covariates related to body composition, heart rate, among others. Validation of the predictive model.
2. To characterise and define the profile of the population diagnosed with lymphoma at the physical, emotional, and biochemical (biomarker) and immune system level prior to an intervention with exercise.
3. To investigate whether the implementation of an exercise programme adjuvant to immunochemotherapy treatment modifies fatigue, adherence (actual dose-intensity), and toxicity related to clinical treatment.
4. To analyse whether the intervention with exercise is effective in increasing strength levels, improving quality of life and sleep.
5. To clarify whether there are sex differences in the efficacy of the exercise programme adjuvant to immunochemotherapy treatment.
6. To analyse the benefit of adding exercise programmes in different subgroups of people with lymphoma, with a special focus on the group of patients aged ≥70 years, with the aim of maximising the cost-effectiveness of implementation in the care routine in all patients.
7. To analyse the degree of adherence to the programme: degree of attendance at planned sessions and percentage of participants who complete the post-intervention evaluation.
8. To report the degree of satisfaction by people affected by lymphoma, as reported in an interview.

Eligibility criteria: Inclusion Criteria:

* Age: ≥18 years old.
* Diagnosis of lymphoma with histological confirmation and requirement of systemic treatment including chemotherapy.
* Time available (80 minutes, two days a week for 20 weeks) to carry out physical exercise sessions.
* Have a mobile phone to be able to contact the person and download the physical activity level app.
* Eastern Cooperative Oncology Group performance status (ECOG) ≤2.
* Life expectancy \&amp;gt;12 months.
* Availability and desire to participate throughout the study period.

Exclusion Criteria:

* Have a contraindication to moderate-high intensity exercise.
* Other significant medical disorders: including psychiatric illnesses chronic or recurrent; intellectual disability, musculoskeletal problems, cardiac or pulmonary disorders that interfere with physical exercise; other malignant tumors in the last five years, with the exception of therapeutically controlled skin cancer; any other illness that may be seen affected or aggravated by physical exercise.
* Have plans to be outside city more than two weeks.
* People who are already physically active (that comply with the recommendations of WHO: \&amp;gt; 150 minutes of exercise moderate/weekly, plus training force two days/week).
* Treatment based only with immunotherapy.
* Central nervous system involvement due to lymphoma.
* Have any important history that limit the capacity of the patient to participate in the study.

Primary outcomes:
measure: Cardiorespiratory fitness (CRF)
timeFrame: 20 weeks
Secondary outcomes:
measure: Sociodemographic, etiological and clinical health variables (A)
timeFrame: 20 weeks
measure: Sociodemographic, etiological and clinical health variables (B)
timeFrame: 20 weeks
measure: Sociodemographic, etiological and clinical health variables (C)
timeFrame: 20 weeks
measure: Sociodemographic, etiological and clinical health variables (D)
timeFrame: 20 weeks
measure: Sociodemographic, etiological and clinical health variables (E)
timeFrame: 20 weeks
measure: Sociodemographic, etiological and clinical health variables (F)
timeFrame: 20 weeks
measure: Functionality and fragility variables at times T0, T1 and T2 (A.1.)
timeFrame: 20 weeks
measure: Functionality and fragility variables at times T0, T1 and T2 (A.2.)
timeFrame: 20 weeks
measure: Functionality and fragility variables at times T0, T1 and T2 (B.1.)
timeFrame: 20 weeks
measure: Functionality and fragility variables at times T0, T1 and T2 (B.2.)
timeFrame: 20 weeks
measure: Functionality and fragility variables at times T0, T1 and T2 (C)
timeFrame: 20 weeks
measure: Functionality and fragility variables at times T0, T1 and T2 (D)
timeFrame: 20 weeks
measure: Functionality and fragility variables at times T0, T1 and T2 (E)
timeFrame: 20 weeks
measure: Functionality and fragility variables at times T0, T1 and T2 (F)
timeFrame: 20 weeks
measure: Functionality and fragility variables at times T0, T1 and T2 (G)
timeFrame: 20 weeks
measure: Functionality and fragility variables at times T0, T1 and T2 (H)
timeFrame: 20 weeks
measure: Patient Reported Results (A)
timeFrame: 20 weeks
measure: 3. Patient-reported results (PRO):
timeFrame: 20 weeks
measure: Biomarkers
timeFrame: 20 weeks
measure: Variables of Geriatric Assessment (VGA) comprehensive in patients (A)
timeFrame: 20 weeks
measure: Variables of Geriatric Assessment (VGA) comprehensive in patients (B)
timeFrame: 20 weeks
measure: Variables of Geriatric Assessment (VGA) comprehensive in patients (C)
timeFrame: 20 weeks
measure: Variables of Geriatric Assessment (VGA) comprehensive in patients (D)
timeFrame: 20 weeks
measure: Variables of Geriatric Assessment (VGA) comprehensive in patients (E)
timeFrame: 20 weeks
measure: Variables of Geriatric Assessment (VGA) comprehensive in patients (F)
timeFrame: 20 weeks
measure: Variables of Geriatric Assessment (VGA) comprehensive in patients (G)
timeFrame: 20 weeks
measure: Variables of Geriatric Assessment (VGA) comprehensive in patients (H)
timeFrame: 20 weeks
measure: Variables of Geriatric Assessment (VGA) comprehensive in patients (I)
timeFrame: 20 weeks
measure: Treatment data and results after the intervention (T2) (A)
timeFrame: 20 weeks
measure: Treatment data and results after the intervention (T2) (B)
timeFrame: 20 weeks
measure: Treatment data and results after the intervention (T2) (C)
timeFrame: 20 weeks
measure: Treatment data and results after the intervention (T2) (D)
timeFrame: 20 weeks
measure: Assessment of the intervention at T2 (A)
timeFrame: 20 weeks
measure: Assessment of the intervention at T2 (B)
timeFrame: 20 weeks
measure: Assessment of the intervention at T2 (C)
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Vitoria - Gateiz
country: Spain
facility: Hospital Universitario Araba (HUA)
state: Araba
city: Galdakao
country: Spain
facility: Hospital Universitario Galdakao (HUG)
state: Bizkaia
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia (HUD)
state: Guipuzcoa
Study officials:
affiliation: Hospital Donostia
name: Izaskun Zeberio Etxetxipia
role: PRINCIPAL_INVESTIGATOR
References: