Exercise During Chemotherapy Treatment As Adjuvant Program in Patients with Lymphoma: EDONOLA Study.

Ejercicio Físico Durante El Tratamiento De Quimioterapia Como Programa Adyuvante En Pacientes Con Linfoma: Estudio EDONOLA

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma
• Intervention / Treatment: Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Research Platform - Health Research Institut Biogipuzkoa; Phone Number: +34943006140; Email: OSID.INVESTCLINICA@osakidetza.eus

Study Locations

• Spain
  • Araba
    • Vitoria - Gateiz, Araba, Spain, 01009
      • Not yet recruiting
      • Hospital Universitario Araba (HUA)
      • Contact: Clinical Research Platform - Clinical Research Institute Biogipuzkoa; Email: OSID.INVESTCLINICA@osakidetza.eus
  • Bizkaia
    • Galdakao, Bizkaia, Spain, 48960
      • Active, not recruiting
      • Hospital Universitario Galdakao (HUG)
  • Guipuzcoa
    • San Sebastián, Guipuzcoa, Spain, 20014
      • Recruiting
      • Hospital Universitario Donostia (HUD)
      • Contact: Clinical Research Platform - Clinical Research Institute Biogipuzkoa; Email: OSID.INVESTCLINICA@osakidetza.eus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 >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: > 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The control group will receive the usual care and indications.
Experimental: Intervention Group; The interventional group will add a exercise program.	Other: Exercise; 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 PE 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory fitness (CRF)	Measured by peak oxygen uptake (VO2peak) before starting chemotherapy treatment and after 20 weeks of intervention, using the cardiorespiratory exercise test.	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic, etiological and clinical health variables (A)	Recruitment Center (Donostia University Hospital, Galdakao University Hospital , Alava University Hospital)	20 weeks
Sociodemographic, etiological and clinical health variables (B)	Birthdate.	20 weeks
Sociodemographic, etiological and clinical health variables (C)	Biological sex (man, woman, I prefer not to answer)	20 weeks
Sociodemographic, etiological and clinical health variables (D)	Gender (man, woman, non-binary or I prefer not to answer)	20 weeks
Sociodemographic, etiological and clinical health variables (E)	Educational level (no studies, elementary, high school, vocational training, university, I prefer not to answer, others)	20 weeks
Sociodemographic, etiological and clinical health variables (F)	Home composition (single person, lives with couple, lives with family, institutionalized, I prefer not to answer, others)	20 weeks
Functionality and fragility variables at times T0, T1 and T2 (A.1.)	Muscle power and fragility --> SIT - TO STAND (STS) POWER: time to repeat the action 5 (sec)	20 weeks
Functionality and fragility variables at times T0, T1 and T2 (A.2.)	Muscle power and fragility --> FRAILTY TRAIT TEST SCALE (FTS-5): BMI (kg/m)2; running time (sec); grip strength (kg); Progressive Romberg Test (positive/negative).	20 weeks
Functionality and fragility variables at times T0, T1 and T2 (B.1.)	G8 Scale (0-17 pts)	20 weeks
Functionality and fragility variables at times T0, T1 and T2 (B.2.)	Fried Frailty Phenotype (0-5 pts)	20 weeks
Functionality and fragility variables at times T0, T1 and T2 (C)	Physical Condition: Modified Shuttle Walking Field Test (meters)	20 weeks
Functionality and fragility variables at times T0, T1 and T2 (D)	UPPER BODY MUSCLE STRENGTH (HANGRIP) (Newton)	20 weeks
Functionality and fragility variables at times T0, T1 and T2 (F)	Physical activity level --> Global Questionnaire on Physical Activity (GPAQ)	20 weeks
Functionality and fragility variables at times T0, T1 and T2 (G)	Sleep Quality --> Epworth Sleepiness Scale (ESS EPWORTH) (0-24 pts)	20 weeks
Functionality and fragility variables at times T0, T1 and T2 (H)	Acelerometry (h/d)	20 weeks
Patient Reported Results (A)	Quality of Life Questionnaire --> Hematological Malignancy - Patient Reported Outcome (HM-PRO) at times T0, T1 and T2 (Nothing, mild and serious)	20 weeks
3. Patient-reported results (PRO):	EORTC QLQ - FA13	20 weeks
Biomarkers	Inflammation (pg/ml or ng/ml), Hematological (pg/ml or ng/ml), Endocrine Nutritional (pg/ml or ng/ml), Immunosenescence (pg/ml or ng/ml),	20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (A)	Gijon Scale (3-15 pts)	20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (B)	Basic Activity of Dialy Living (BADL) - Barthel Scale (0-10 pts)	20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (C)	Instrumental Activity of Dialy Livings (IADL) - Lawton Scale (0-8 pts)	20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (D)	Cognitive Function - Pfeiffer Test (0-10 pts)	20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (E)	Nutritional Status - Mini Nutritional Assessment Short-form (MNA.SFI) (0-14 pts)	20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (F)	Polypharmacy (number of chronica drug consumed by the participant)	20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (G)	Geriatric Syndromes - Immobility and pressure ulcers (Yes/No); instability and falls (Yes/No); urinary and faecal incontinence (Yes/No); dementia and acute confusional syndrome ( Yes//No); malnutrition (Yes/No); alterations in sight and hearing (Yes/No);constipation, faecal impaction (Yes/No);depression/insomnia (Yes/No)	20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (H)	Pain - Visual Analogue Scale (VAS) (0-10 pts)	20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (I)	Emotional Distress - Stress Thermometer (0-10 pts)	20 weeks
Treatment data and results after the intervention (T2) (A)	Treatment Suspension (Yes/No)	20 weeks
Treatment data and results after the intervention (T2) (B)	Dose Reduction (Yes/No)	20 weeks
Treatment data and results after the intervention (T2) (C)	Treatment percentage completed (%)	20 weeks
Treatment data and results after the intervention (T2) (D)	Treatment Completion (Yes/No)	20 weeks
Assessment of the intervention at T2 (A)	Adverse events associated with intervention (Number of adverse events)	20 weeks
Assessment of the intervention at T2 (B)	Satisfaction with the intervention (Yes/No)	20 weeks
Assessment of the intervention at T2 (C)	Adherence to the intervention (Yes/No)	20 weeks
Functionality and fragility variables at times T0, T1 and T2 (E)	Body composition --> Height (cm); Weight (kg); Waist circumference (cm); hip circumference (cm); body mass index (kg/m2); fat free mass (kg and %); fat mass (kg and %); total body water (kg and %); phase angle (º); systolic blood pressure (mmHG); diastolic blood presure (mmHg); resistance (Ω); reactance (Ω).	20 weeks

Collaborators and Investigators

• Sponsor: Biogipuzkoa Health Research Institute
• Investigators: Principal Investigator: Izaskun Zeberio Etxetxipia, Hospital Donostia

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Fatigue; Lymphoma; Physical Exercise; Life Quality; Cardiorespiratory capacity
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: EDONOLA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No