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

Breast Neoplasms Clinical Trial

— EFICANCER  

Official title:

PHYSICAL EXERCISE TO IMPROVE THE QUALITY OF LIFE OF CANCER PATIENTS DURING TREATMENT PROCESS: EFICANCER STUDY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01786122
• Other study ID #: EFICANCER PI12/02113
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2013
• Last updated: July 22, 2014
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2014
• Source: Basque Health Service
• Contact: Gonzalo Grandes, Medicine
• Phone: 0034946006637
• Email: GONZALO.GRANDESODRIOZOLA[@]osakidetza.net
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Lung Neoplasms
• Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Other:
• Supervised Physical activity
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 month

Behavioral:
• education program on healthy habits
education program on healthy habits for 2 months in the PHC and a second phase in community facilities during the remaining 10 months

Locations

Country	Name	City	State
Spain	Primary Care Research Unit of Bizkaia	Bilbao	Bizkaia

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Health Related Quality of Life (EORTC QLQ-C30)		basal,2,6,12 months fllow up	No
Secondary	asthenia measurement with FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionaire		Basal, 2,6 and12 months	Yes
Secondary	Functional Capacity-6 minute Walking test		basal, 2,6 and 12 months	No
Secondary	cardiorespiratory test		basal, 2, 6 and12 months	No
Secondary	Changes in Muscular Strenght-Dynamometer		basal, 2,6 nad 12 months	No
Secondary	progression-free survival		basal, 2, 6 and 12 months	No