Football Fitness After Breast Cancer (FFABC)

University of Copenhagen

Status: Completed

Conditions: Breast Neoplasm Female

Treatments: Behavioral: Football fitness

Study type: Interventional

Funder types: Other

Identifiers

NCT03284567

FFABC

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 2 patient groups

Football fitness

Active Comparator group

Description:

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.

Treatment:

Behavioral: Football fitness

Control group

No Intervention group

Description:

Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.