Breast Cancer Clinical Trial
— SAPAOfficial title:
Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase
NCT number | NCT01322412 |
Other study ID # | I10 009 / SAPA |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2011 |
Est. completion date | July 2013 |
Verified date | March 2011 |
Source | University Hospital, Limoges |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Physical exercise has been identified as a major item of many chronic diseases and cancer
rehabilitation.
Therefore, physical activity for health is a valid and relevant way to improve quality of
life and to manage cancer patient fatigue. The aim of the study is the assessment of the
effects of a physical activity retraining program on aerobic capacity, strength and fatigue,
in a breast cancer population treated by adjuvant chemotherapy.
Status | Completed |
Enrollment | 44 |
Est. completion date | July 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - females between 18 and 75 years of age - signed written informed consent - willing to take part in the trial and to follow the instructions - breast tumour, histologically documented - patients who have undergone curative surgery - patients for whom a 6-treatment course of adjuvant chemotherapy (3FEC100 + taxanes) and radiotherapy has been scheduled - patients with HER2-negative cancer. Exclusion Criteria: - metastatic cancer - other primary tumours - disability preventing a proper understanding of the instructions for the trial - chemotherapy strictly contra-indicated - patients who are subject to a court protection, wardship or guardianship order - uncontrolled hypertension - family history of sudden death in a first-degree relative - unstabilised heart disease - current treatment with beta-blockers - chronic or acute pulmonary disease associated with dyspnoea upon moderate effort - uncontrolled thyroid dysfunction - uncontrolled diabetes - any other serious conditions that are unstabilised, disabling or in which physical exercise is contra-indicated - unable to attend for follow-up throughout the duration of the study - ventricular ejection fraction (vef) < 50%, pregnancy or suckling. |
Country | Name | City | State |
---|---|---|---|
France | Limoges University Hospital | Limoges |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Limoges |
France,
Cornette T, Vincent F, Mandigout S, Antonini MT, Leobon S, Labrunie A, Venat L, Lavau-Denes S, Tubiana-Mathieu N. Effects of home-based exercise training on VO2 in breast cancer patients under adjuvant or neoadjuvant chemotherapy (SAPA): a randomized cont — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme | 27 weeks | ||
Secondary | Assessment at 27 and 54 weeks between the 2 groups of muscle function. | 54 weeks |
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