Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients

Not Applicable

• Conditions: Non-Small-Cell Lung Carcinoma; Breast Neoplasms; Digestive System Neoplasms

• Registration Number: NCT01786122
• Lead Sponsor: Basque Health Service

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-07
• Study Start: 2013-04
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-22
• Last Update Posted: 2014-07-23
• Primary Completion: 2015-01
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Health Related Quality of Life (EORTC QLQ-C30)	basal,2,6,12 months fllow up

Secondary Outcome Measures

Name	Time	Method
asthenia measurement with FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionaire	Basal, 2,6 and12 months
cardiorespiratory test	basal, 2, 6 and12 months
Functional Capacity-6 minute Walking test	basal, 2,6 and 12 months
Changes in Muscular Strenght-Dynamometer	basal, 2,6 nad 12 months
progression-free survival	basal, 2, 6 and 12 months

Trial Locations

Locations (1)

Primary Care Research Unit of Bizkaia; 🇪🇸 Bilbao, Bizkaia, Spain