Football Fitness After Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial to Investigate the Health Promoting Effects of a Football Fitness Intervention for Women After Treatment for Breast Cancer

Conditions
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Breast Neoplasm Female

Intervention / Treatment
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* Behavioral: Football fitness


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Football fitness<br>Participants in the intervention group will practice soccer for 52 weeks two times weekly. A soccer instructor will be in charge of all training sessions. 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. Participants will be told to avoid hard tackles and other actions that carry a risk of injury. | Behavioral: Football fitness<br>* 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<br>|
| No Intervention: Control group<br>Participants in the control group will receive verbal advice about the benefits of exercise and physical activity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12. | Incremental test to exhaustion on a cycle ergometer. | 6 months and 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in whole-body fat mass from baseline to month 6 and month 12. | Assessed by dual energy x-ray absorptiometry. | 6 months and 12 months. | 
| Mean change in whole-body weight from baseline to month 6 and month 12. | Body weight was measured with a digital platform scale. | 6 month and 12 month. | 
| Mean change in whole-body muscle mass from baseline to month 6 and month 12. | Assessed by dual energy x-ray absorptiometry. | 6 month and 12 month. | 
| Mean change in muscle strength from baseline to month 6 and month 12. | Dynamic concentric muscle strength for the knee extensors (1RM). | 6 month and 12 month. | 
| Mean change in balance from baseline to month 6 and month 12. | Single-leg flamingo balance test. | 6 month and 12 month. | 
| Mean change in blood pressure from baseline to month 6 and month 12. | Blood pressure will be measured with a digital sphygmomanometer. | 6 month and 12 month. | 
| Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12. | 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. | 6 month and 12 month. | 
| Mean change in cholesterol from baseline to month 6 and month 12. | 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). | 6 month and 12 month. | 
| Self-reported physical activity from baseline to month 6 and month 12. | Assessed by the International Physical Activity Questionnaire (IPAQ). | 6 month and 12 month. | 
| Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12. | Assessed by the supplement EORTC QLQ-BR23. | 6 month and 12 month. | 
| Self-reported health-related quality of life outcomes from baseline to month 6 and month 12. | Assessed by the 15 subscales of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30). | 6 month and 12 month. | 
| Self-reported functional level in upper extremities from baseline to month 6 and month 12. | Assessed by disabilities of the arm, shoulder and hand (DASH). | 6 month and 12 month. | 
| Self-reported health related quality of life from baseline to month 6 and month 12. | Assessed by The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) | 6 month and 12 month. | 
| Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck. | Assessed by dual energy x-ray absorptiometry. | 6 month and 12 month. | 
| Mean change in total body and leg bone mineral content (BMC). | Assessed by dual energy x-ray absorptiometry. | 6 month and 12 month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Football, Late effects, Physical exercise, Soccer training, Rehabilitation, Bone mineralization, Body composition, Fitness, Aerobic capacity