Spots Global Cancer Trial Database for Activity Program During Aromatase Inhibitor Therapy
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Trial Identification
Brief Title: Activity Program During Aromatase Inhibitor Therapy
Official Title: A 24 Weeks Activity Program in Patients With Early Breast Cancer Receiving Aromatase Inhibitor Therapy. A Multicenter Randomized Phase III Trial
Study ID: NCT03786198
Conditions
Study Description
Brief Summary: The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant aromatase inhibitor (AI) therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.
Detailed Description: After tumor removal, patients with hormone receptor positive breast cancer tumors often receive adjuvant endocrine treatment, with the use of an aromatase inhibitor (AI) being standard of care in the population of postmenopausal women. Common side effects of AI therapy are joint pain, muscle pain, stiffness, fatigue, hot flashes, and weight gain. Arthralgia and/or myalgia can result in lower physical activity and can negatively influence quality of life (QoL). In addition, muscle or joint pain/stiffness are among the main reasons for non-compliance and discontinuation of AI therapy. Because AI therapy is usually administered for 5 and sometimes even 10 years, this is a major clinical challenge. For breast cancer patients undergoing AI therapy, physical activity can provide potential benefit by reducing muscle/joint pain and fatigue and can thus improve QoL. The preventive effect of physical activity on AI side effects, however, remains elusive. In addition, activity programs to reduce AI side effects have so far mostly been rather complex. The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant AI therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients. Furthermore, this trial will assess the effect of physical activity on symptom burden in general and quality of life in patients receiving adjuvant AI therapy. During the follow-up phase, the trial will assess whether this intervention leads to a sustained change in lifestyle regarding activity, less pain, and better treatment adherence in the intervention group.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Kantonsspital Aarau, Aarau, , Switzerland
Kantonsspital Baden, Baden, , Switzerland
CABA - Zentrum für Onkologie, Psychologie und Bewegung, Basel, , Switzerland
Brustzentrum Basel - Praxis für ambulante Tumortherapie, Basel, , Switzerland
Universitätsspital Basel, Basel, , Switzerland
Inselspital Bern, Bern, , Switzerland
Hirslanden Brustzentrum Bern Biel, Bern, , Switzerland
Kantonsspital Graubünden, Chur, , Switzerland
Tumorzentrum ZeTuP Chur, Chur, , Switzerland
Clinique des Grangettes, Centre du sein, Chêne-Bougeries, , Switzerland
Brustzentrum Thurgau, Frauenfeld, , Switzerland
Centre du sein Fribourg / Brustzentrum Freiburg, Fribourg, , Switzerland
Clinique De Genolier, Genolier, , Switzerland
FOLM - Fondazione Oncologia Lago Maggiore, Locarno, , Switzerland
Oncologia Varini&Calderoni&Christinat, Lugano, , Switzerland
Kantonsspital Luzern, Luzerne, , Switzerland
Hirslanden Klinik St. Anna, Luzern, , Switzerland
Onkologie Zentrum Spital Männedorf, Manno, , Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli, Mendrisio, , Switzerland
Hôpital Neuchâtelois, Neuenhof, , Switzerland
Kantonsspital Olten, Olten, , Switzerland
Tumorzentrum ZeTuP Rapperswil-Jona, Rapperswil-Jona, , Switzerland
Brustzentrum Ostschweiz, Saint Gallen, , Switzerland
Rundum Onkologie am Bahnhofpark, Sargans, , Switzerland
Hôpital de Sion, Sion, , Switzerland
Tumorzentrum ZeTUP, St. Gallen, , Switzerland
Kantonsspital St. Gallen, St. Gallen, , Switzerland
Regionalspital Thun, Thun, , Switzerland
Kantonsspital Winterthur, Brustzentrum, Winterthur, , Switzerland
Onkologie Bellevue, Zurich, , Switzerland
Brustzentrum Zürich, Zürich, , Switzerland
Universitäts Spital Zürich, Zürich, , Switzerland
Contact Details
Name: Friedemann Honecker, MD
Affiliation: Tumor- und Brustzentrum ZeTuP St.Gallen
Role: STUDY_CHAIR
Name: Nicolette Hoefnagels, MSc
Affiliation: Tumor- und Brustzentrum ZeTuP St.Gallen
Role: STUDY_CHAIR
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