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

NCT06660446 | Recruiting DMC

• 1 other identifier: EDONOLA
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

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.

Conditions

Lymphoma

Keywords

Lymphoma; Physical Exercise; Fatigue; Cardiorespiratory capacity; Life Quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (35)

• Sociodemographic, etiological and clinical health variables (A)

  20 weeks

• Sociodemographic, etiological and clinical health variables (B)

  20 weeks

• Sociodemographic, etiological and clinical health variables (C)

  20 weeks

• Sociodemographic, etiological and clinical health variables (D)

  20 weeks

• Sociodemographic, etiological and clinical health variables (E)

  20 weeks

Study Arms (2)

Control Group

NO INTERVENTION

The control group will receive the usual care and indications.

Intervention Group

EXPERIMENTAL

The interventional group will add a exercise program.

Other: Exercise

Interventions

Exercise OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogipuzkoa Health Research Institute: lead

Study Sites (3)

Hospital Universitario Araba (HUA)

Vitoria - Gateiz, Araba, 01009, Spain

NOT YET RECRUITING

Hospital Universitario Galdakao (HUG)

Galdakao, Bizkaia, 48960, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Donostia (HUD)

San Sebastián, Guipuzcoa, 20014, Spain

RECRUITING

MeSH Terms

Conditions

Lymphoma; Motor Activity; Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Izaskun Zeberio Etxetxipia

  Hospital Donostia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Platform - Health Research Institut Biogipuzkoa

CONTACT

+34943006140; OSID.INVESTCLINICA@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 28, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

ES (3)