NCT03284567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

2.7 years

First QC Date

September 13, 2017

Last Update Submit

September 30, 2021

Conditions

Breast Neoplasm Female

Keywords

Breast cancerFootballLate effectsPhysical exerciseSoccer trainingRehabilitationBone mineralizationBody compositionFitnessAerobic capacity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • Mean change in whole-body fat mass from baseline to month 6 and month 12.

    6 months and 12 months.

  • Mean change in whole-body weight from baseline to month 6 and month 12.

    6 month and 12 month.

  • Mean change in whole-body muscle mass from baseline to month 6 and month 12.

    6 month and 12 month.

  • Mean change in muscle strength from baseline to month 6 and month 12.

    6 month and 12 month.

  • Mean change in balance from baseline to month 6 and month 12.

    6 month and 12 month.

  • +10 more secondary outcomes

Study Arms (2)

Football fitness

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

Football fitnessBEHAVIORAL

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

Football fitness

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • Bloomquist K, Krustrup P, Fristrup B, Sorensen V, Helge JW, Helge EW, Soelberg Vadstrup E, Rorth M, Hayes SC, Uth J. Effects of football fitness training on lymphedema and upper-extremity function in women after treatment for breast cancer: a randomized trial. Acta Oncol. 2021 Mar;60(3):392-400. doi: 10.1080/0284186X.2020.1868570. Epub 2021 Jan 11.

    PMID: 33423594DERIVED

  • Uth J, Fristrup B, Sorensen V, Helge EW, Christensen MK, Kjaergaard JB, Moller TK, Mohr M, Helge JW, Jorgensen NR, Rorth M, Vadstrup ES, Krustrup P. Exercise intensity and cardiovascular health outcomes after 12 months of football fitness training in women treated for stage I-III breast cancer: Results from the football fitness After Breast Cancer (ABC) randomized controlled trial. Prog Cardiovasc Dis. 2020 Nov-Dec;63(6):792-799. doi: 10.1016/j.pcad.2020.08.002. Epub 2020 Aug 12.

    PMID: 32800792DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Personnel assessing the primary outcome is blinded for study participants group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoc

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 15, 2017

Study Start

March 20, 2017

Primary Completion

November 30, 2019

Study Completion

January 20, 2020

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)