An interventional study of Football fitness in Breast Neoplasm Female, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-10-01.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Supportive care
Among 226 studies in Breast Neoplasms with a site in Denmark — 29 open to participants now, 57 under way, 22 of them phase 3. Breast Neoplasms · Denmark.
Among the 226 studies in Breast Neoplasms with a site in Denmark, this one is the 140th largest by enrollment of the 193 interventional ones that give a count, is one of 13 that started in 2017, is one of 55 with no phase, and was the 138th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →29 of the 226 studies in Breast Neoplasms with a site in Denmark are open now. Recruiting first, the newest first:
UMC Utrecht · Sites in Denmark, Germany, Netherlands and 1 more country
Novartis Pharmaceuticals · Sites in Denmark, United States, Canada and 8 more countries
Novartis Pharmaceuticals · Sites in Denmark, United States, Canada and 4 more countries
Vejle Hospital · Sites in Denmark
Relay Therapeutics, Inc. · Sites in Denmark, United States, Argentina and 24 more countries
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years to 75 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
226 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 36 · Phase 2 54 · Phase 3 58 · Phase 4 7
First in 1990; this study’s year is marked. 13 started in 2017.
This study's enrollment of 69 is close to the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 210 across the 193 interventional studies, 200 across the 31 observational. Of the 147 that completed or were terminated, 52 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
98 of 226 have an industry lead sponsor. The 10 most frequent:
University of Copenhagen is the lead sponsor of 466 studies on the registry; 64 are open to participants now.
University of Copenhagen has 4 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
17 of the studies in Breast Neoplasms with a site in Denmark that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05038735Phase 3Novartis PharmaceuticalsStudy to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. | 2027-01-28 |
| NCT04873362Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy | 2027-03-31 |
| NCT04421963Phase 3AstraZenecaRoll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib | 2027-04-06 |
| NCT04784715Phase 3AstraZenecaTrastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | 2027-05-03 |
| NCT06312176Phase 3Merck Sharp & Dohme LLCA Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) | 2027-07-11 |
Among the 226 studies in Breast Neoplasms with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.
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
Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
Incremental test to exhaustion on a cycle ergometer.
Time frame: 6 months and 12 months.
Mean change in whole-body fat mass from baseline to month 6 and month 12.
Assessed by dual energy x-ray absorptiometry.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 6 month and 12 month.
Mean change in balance from baseline to month 6 and month 12.
Single-leg flamingo balance test.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 6 month and 12 month.
Mean change in total body and leg bone mineral content (BMC).
Assessed by dual energy x-ray absorptiometry.
Time frame: 6 month and 12 month.
Plan to share: No
Ran from Mar 2017 to primary completion in Nov 2019, 32 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 32 months is close to that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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