Clinical trial NCT01786122: Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients
Official title: PHYSICAL EXERCISE TO IMPROVE THE QUALITY OF LIFE OF CANCER PATIENTS DURING TREATMENT PROCESS: EFICANCER STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Small-Cell Lung Carcinoma
Digestive System Neoplasms
Breast Neoplasms
Keywords: physical exercise
Health Related Quality of Life
Non-Small-Cell Lung Carcinoma
digestive system neoplasms
breast neoplasms
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2013-02-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Changes in Health Related Quality of Life (EORTC QLQ-C30)
timeFrame: basal,2,6,12 months fllow up
Secondary outcomes:
measure: asthenia measurement with FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionaire
timeFrame: Basal, 2,6 and12 months
measure: Functional Capacity-6 minute Walking test
timeFrame: basal, 2,6 and 12 months
measure: cardiorespiratory test
timeFrame: basal, 2, 6 and12 months
measure: Changes in Muscular Strenght-Dynamometer
timeFrame: basal, 2,6 nad 12 months
measure: progression-free survival
timeFrame: basal, 2, 6 and 12 months
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Primary Care Research Unit of Bizkaia
state: Bizkaia
Study officials:
affiliation: Primary Care Research Unit of Bizkaia (Basque Health Service)
name: GRANDES GONZALO, Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: Primary Care Research Unit of Bizkaia (Basque Health Service)
name: ARIETALEANIZBEASCOA MARIA SOLEDAD, NURSE
role: STUDY_DIRECTOR
References:
citation: Sancho 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.