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. 2016 Sep 21;2016(9):CD005001. doi: 10.1002/14651858.CD005001.pub3

NCT02240836.

Trial name or title Energy Balance and Breast Cancer Aspects‐II (EBBA‐II)
Methods RCT, 2 groups
Participants Newly diagnosed breast cancer patients undergoing adjuvant therapy, DCIS grade 3, stage I + II breast cancer
Estimated enrolment: 600 participants
Interventions 12‐month exercise program comprised of strength and endurance training.
Exercise groups supervised by experienced physiotherapists, the participants will attend the exercise groups for training 60 min, 2/week. Additionally, home‐based exercise for > = 120 minutes a week, aiming to perform a total of 240 minutes of exercise per week.
The control group told to follow standard‐care regimen
Outcomes Primary:
  • metabolic profile


Secondary:
  • Relapse of breast cancer disease, breast cancer‐specific mortality, overall mortality, disease‐free survival, recurrence‐free interval

  • QoL parameters: QoL, fatigue, anxiety, depression

  • Cardiopulmonary function: cardiopulmonary exercise testing (CPET), VO2 max, forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), diffusing capacity of the lung for carbon monoxide (DLCO)

Starting date September 2014
Contact information Inger Thune
inger.thune@uit.no
Notes Estimated primary completion date: May 2016
Planned follow‐up: 10 years