Dr. Friedemann Honecker / N. Hoefnagels, MSc
Organization: Tumor- und Brustzentrum, ZeTuP St. Gallen
Project Name: WISE STUDY: Walking Intervention for Symptom Elimination under aromatase inhibitor therapy
Funding Year: 2017
Project period: 5 years
WISE STUDY: Walking Intervention for Symptom Elimination under aromatase inhibitor therapy
This multicenter, randomized, intervention is composed of a 24-week home-based walking program starting at the onset of AI treatment. This involves continuous moderate intensive walking outdoors for 30 mins, 5 days a week.
350 breast cancer survivors at the onset of adjuvant AI therapy will be randomized to the intervention or control group.
Approximately 70-80% of all breast cancers are hormone receptor-positive. After tumor removal, these patients are recommended anti-hormonal therapy, with the use of an aromatase inhibitor (AI) being standard of care in postmenopausal women. AI-therapy can cause side effects ranging from disturbing to debilitating, especially joint/muscle pain and stiffness, but also fatigue, hot flashes, etc.
The benefit of physical activity on manifested muscle/joint pain and stiffness under AI-therapy is well established. The purpose of our patient focused trial is to investigate whether physical activity has a preventive effect on side effects of AI-therapy.
Patients are randomly allocated at the beginning of an AI-therapy to either an intervention arm (consisting of walking outdoors continuously for at least 30 minutes a day, 5 days a week for 24 weeks) or a control arm (no specific recommendation regarding physical activity). Patients in both arms wear a wrist-worn activity tracker with customized display (intervention arm: feedback about activity performed; control arm: no feedback).
Aim of the Trial:
The aim of this trial is to investigate if a simple outdoor walking intervention, beginning at the start of AI-therapy, can prevent muscle/ joint pain and stiffness and can positively affect symptom burden and quality of life in general.
During a follow-up phase of 1.5 years, the trial will assess whether the trial shows a lasting effect on pain, treatment adherence, an active lifestyle, and quality of life in general in the intervention arm compared to the control arm.