Exercise program for lymphoma patients undergoing chemotherapy
Ejercicio Físico Durante El Tratamiento De Quimioterapia Como Programa Adyuvante En Pacientes Con Linfoma: Estudio EDONOLA
This study tests whether a special exercise program can help older lymphoma patients undergoing chemotherapy feel stronger, less tired, and improve their overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biogipuzkoa Health Research Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Vitoria - Gateiz, Araba and 2 other locations) |
| Trial ID | NCT06660446 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a tailored exercise program for adults diagnosed with lymphoma who are receiving immunochemotherapy. The intervention aims to enhance cardiorespiratory fitness, strength, psychological well-being, and overall quality of life while reducing fatigue and frailty. The research focuses on a homogeneous group of lymphoma patients, particularly those aged 70 and older, and seeks to provide scientific evidence in a field that has been minimally studied. Additionally, the study will analyze the effects of exercise from a gender perspective, addressing baseline differences and outcomes post-intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with lymphoma who are currently receiving systemic treatment, including chemotherapy.
Not a fit: Patients with contraindications to moderate-high intensity exercise or significant medical disorders that interfere with physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and physical fitness of lymphoma patients undergoing treatment.
How similar studies have performed: While there is limited scientific evidence specifically for lymphoma patients, similar exercise interventions in cancer care have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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 \>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.
Where this trial is running
Vitoria - Gateiz, Araba and 2 other locations
- Hospital Universitario Araba (HUA) — Vitoria - Gateiz, Araba, Spain (Not_yet_recruiting)
- Hospital Universitario Galdakao (HUG) — Galdakao, Bizkaia, Spain (Active_not_recruiting)
- Hospital Universitario Donostia (HUD) — San Sebastián, Guipuzcoa, Spain (Recruiting)
Study contacts
- Principal investigator: Izaskun Zeberio Etxetxipia — Hospital Donostia
- Study coordinator: Clinical Research Platform - Health Research Institut Biogipuzkoa
- Email: OSID.INVESTCLINICA@osakidetza.eus
- Phone: +34943006140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.