Breast Neoplasm Female
Conditions
Keywords
Breast cancer, Football, Late effects, Physical exercise, Soccer training, Rehabilitation, Bone mineralization, Body composition, Fitness, Aerobic capacity
Brief summary
Late effects of breast cancer treatment are widely reported including deteriorating fitness, fatigue, loss of muscle and bone mass, and increased body fat percentage. Exercise interventions may ameliorate a number of these effects including fatigue, fitness and improve quality of life. However only limited knowledge exists on the potential of novel interventions and settings, such as sports outside the hospital setting, to improve late effects of breast cancer treatment. The 'Football Fitness After Breast Cancer' (FF ABC) study is a randomized trial comparing the effects of a football training intervention with standard treatment approaches on fitness, bone mineralization, body composition, muscle strength, blood pressure, and patient-reported outcomes in women treated for breast cancer.
Interventions
BEHAVIORALFootball fitness
The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games. Training will take place on a natural grass pitch. In adverse weather conditions (i.e., \< 5°C or heavy rain) training will be performed indoors
Sponsors
University of Southern Denmark
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Personnel assessing the primary outcome is blinded for study participants group allocation.
Intervention model description
1/3 of participants will be randomly allocated to the control group and 2/3 of participants will be randomly allocated to the Football fitness intervention group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Women surgically managed for breast cancer, local and regional advanced breast cancer. * Completion of adjuvant chemotherapy and radiation therapy. * Legally competent persons with ability to read and understand Danish. * Signed informed consent. * Performance level 0-1 (WHO).
Exclusion criteria
* WHO performance level \> 1. * Osteoporosis (T-score \< -2.5). * Known metastatic breast cancer (stage IV). * Women in DBCG-group I (age =\> 60 years, tumor =\< 10 mm, invasive ductal carcinoma grade I, invasive lobular carcinoma grade I / II, estrogen receptor positive and HER2 normal). * Cardiovascular or pulmonary disorders (e.g., arrhythmias, ischemic heart disease, unregulated high blood pressure, chronic obstructive lung disease). * Ongoing anticoagulant therapy (vitamin K antagonists; Marevan, Marcoumar and low molecular weight heparins; Innohep, Clexane, Fragmin) for pulmonary embolism or deep venous thrombosis (DVT) due to increased bleeding risk of falls and clashes with other players during exercise. * Current or scheduled chemotherapy and radiation therapy in the intervention period (12 months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12. | 6 months and 12 months. | Incremental test to exhaustion on a cycle ergometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in whole-body weight from baseline to month 6 and month 12. | 6 month and 12 month. | Body weight was measured with a digital platform scale. |
| Mean change in whole-body muscle mass from baseline to month 6 and month 12. | 6 month and 12 month. | Assessed by dual energy x-ray absorptiometry. |
| Mean change in muscle strength from baseline to month 6 and month 12. | 6 month and 12 month. | Dynamic concentric muscle strength for the knee extensors (1RM). |
| Mean change in balance from baseline to month 6 and month 12. | 6 month and 12 month. | Single-leg flamingo balance test. |
| Mean change in blood pressure from baseline to month 6 and month 12. | 6 month and 12 month. | Blood pressure will be measured with a digital sphygmomanometer. |
| Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12. | 6 month and 12 month. | Procollagen type I C propeptide, osteocalcin and C-terminal telopeptide will be analyzed by a chemiluminescence method using a fully automated immunoassay system (iSYS, Immunodiagnostic Systems Ltd., Boldon, England. |
| Mean change in cholesterol from baseline to month 6 and month 12. | 6 month and 12 month. | Blood samples will be analyzed at baseline, 6 and 12 month for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, and glycosylated hemoglobin, respectively, by automated analyzers (Cobas Fara, Roche, Neuilly sur Seine, France) using enzymatic kits (Roche Diagnostics, Mannheim, Germany, and Tosoh G7, Tosoh Europe, Tessenderlo, Belgium). |
| Mean change in whole-body fat mass from baseline to month 6 and month 12. | 6 months and 12 months. | Assessed by dual energy x-ray absorptiometry. |
| Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12. | 6 month and 12 month. | Assessed by the supplement EORTC QLQ-BR23. |
| Self-reported health-related quality of life outcomes from baseline to month 6 and month 12. | 6 month and 12 month. | Assessed by the 15 subscales of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30). |
| Self-reported functional level in upper extremities from baseline to month 6 and month 12. | 6 month and 12 month. | Assessed by disabilities of the arm, shoulder and hand (DASH). |
| Self-reported health related quality of life from baseline to month 6 and month 12. | 6 month and 12 month. | Assessed by The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) |
| Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck. | 6 month and 12 month. | Assessed by dual energy x-ray absorptiometry. |
| Mean change in total body and leg bone mineral content (BMC). | 6 month and 12 month. | Assessed by dual energy x-ray absorptiometry. |
| Self-reported physical activity from baseline to month 6 and month 12. | 6 month and 12 month. | Assessed by the International Physical Activity Questionnaire (IPAQ). |
Countries
Denmark
Outcome results
None listed