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

B

Basque Health Service

Status

Unknown

Conditions

Non-Small-Cell Lung Carcinoma
Breast Neoplasms
Digestive System Neoplasms

Treatments

Other: Supervised Physical activity
Behavioral: education program on healthy habits

Study type

Interventional

Funder types

Other

Identifiers

NCT01786122
EFICANCER PI12/02113

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

Exercise group
Experimental group
Description:
supervised exercise program education program on healthy habits Pharmacological treatment and selfcare encouragement
Treatment:
Behavioral: education program on healthy habits
Other: Supervised Physical activity
control group
No Intervention group
Description:
Pharmacological treatment and selfcare encouragement.

Trial contacts and locations

1

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Central trial contact

Gonzalo Grandes, Medicine; Maria Soledad Arietaleanisbeaskoa, Nurse

Data sourced from clinicaltrials.gov

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