Grantee Name:
Dr. Friedemann Honecker / N. Hoefnagels, MSc
Organization:
Tumor- und Brustzentrum, ZeTuP St. Gallen
Country: Switzerland
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.
Link to the study
Link to Clinical Trials
Lay Abstract
Background:
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.
Research Question:
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.
Trial Intervention:
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.
Follow-Up:
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.