Clinical trial · Interventional
Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients
PHYSICAL EXERCISE TO IMPROVE THE QUALITY OF LIFE OF CANCER PATIENTS DURING TREATMENT PROCESS: EFICANCER STUDY
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
AIM: To evaluate the effectiveness and efficiency of an innovative exercise program (EP) for patients during treatment for gastrointestinal tumors, breast and non small cells lung cancer, in terms of improved quality of life (QOL), fatigue and functional capacity respect the usual standard treatment (ST). DESIGN: Pragmatic randomized clinical trial in two parallel groups: EP and ST. SETTING: 7 Primary Health Centers (PHC) of the redIAPPISCIII, in coordination with oncology services. PARTICIPANTS: 250 patients with the above tumors, locally advanced or with metastatic disease, in adjuvant treatment, with Performance Status(PS) PS1-PS0. INTERVENTION: Both groups received standardized usual care. The EP group will receive, in addition, a nurse supervised exercise program for 2 months in the PHC and a second phase in community facilities during the remaining 10 months. MEASUREMENTS: The primary outcome measure is the change from baseline in the QOL+66 treatment, as measured by the specific questionnaire for patients with cancer EORTC QLQ-C-30 and Short Form(SF-36) overall. Secondary: fatigue (FACIT-F), radiological response, functional capacity (6 minutes walking and cardiopulmonary test), muscle strength and progression-free survival and overall. Predictors and confounders: age, sex, stage and tumor type, histology, treatment. ANALYSIS: We will compare between groups mean changes from baseline measurement of quality of life questionnaire (QOL) and other variables, on an intention to treat basis, using longitudinal mixed-effects models for repeated measures at 2, 6 and 12 months follow-up. Cost / effectiveness and cost / incremental utility associated to the program wil be estimated.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Digestive System Neoplasms | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Non-Small-Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| education program on healthy habits | Behavioral | — | UNRESOLVED |
| Supervised Physical activity | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise group
- description
- supervised exercise program education program on healthy habits Pharmacological treatment and selfcare encouragement
- interventionNames
- Other: Supervised Physical activity
- Behavioral: education program on healthy habits
- type
- NO_INTERVENTION
- label
- control group
- description
- Pharmacological treatment and selfcare encouragement.
Primary outcomes (1)
- measure
- Changes in Health Related Quality of Life (EORTC QLQ-C30)
- timeFrame
- basal,2,6,12 months fllow up
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18-70 years * Diagnosis of digestive system cancer , breast cancer or histologically confirmed NSCLC stage IV Physical Status (PS) 0 or 1. * First-line chemotherapy treatment for each type of standard tumor * Adequate renal, liver and blood function. Exclusion Criteria: * Brain metastases * Risk of fracture (bone metastases) * Unstable heart disease, uncontrolled BP Systolic Blood Pressure((SBP)\> 200 or Diastolic Blood Pressure (DBP)\> 110), heart failure (NYHA II or greater), constrictive pericarditis * Other diseases at the discretion of the investigator to be a contraindication for physical exercise. * Perform regular physical activity (150 minutes / week of moderate or vigorous 75)
References
Publications (2)
- DERIVEDMendizabal-Gallastegui N, Arietaleanizbeaskoa MS, Latorre PM, Garcia-Alvarez A, Sancho A, Iruarrizaga E, Lopez-Vivanco G, Grandes G. Nurse-Supervised Exercise for People with Stage IV Cancer: The EFICANCER Randomized Clinical Trial. Semin Oncol Nurs. 2023 Aug;39(4):151448. doi: 10.1016/j.soncn.2023.151448. Epub 2023 May 13. PMID 37183104
- DERIVEDSancho A, Carrera S, Arietaleanizbeascoa M, Arce V, Gallastegui NM, Gine March A, Sanz-Guinea A, Eskisabel A, Rodriguez AL, Martin RA, Lopez-Vivanco G, Grandes G. Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial. BMC Cancer. 2015 Feb 6;15:40. doi: 10.1186/s12885-015-1055-x. PMID 25655792