Clinical trial NCT03786198: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Breast Cancer
Keywords: early breast cancer
aromatase inhibitor therapy
activity program
physical activity
activity tracker
pedometer
stepcounter
Lead sponsor: Swiss Group for Clinical Cancer Research
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 375
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Home-based walking intervention for 24 weeks + standard adjuvant AI therapy
2. Physical activity according to standard recommendations for 24 weeks + standard adjuvant AI therapy
Primary purpose: SUPPORTIVE_CARE

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 criteria: Inclusion Criteria:

* Written informed consent according to Swiss law and ICH/GCP regulations before registration and prior to any trial specific procedures.
* Histologically confirmed hormone-receptor-positive newly diagnosed breast cancer, AJCC (American Joint Committee on Cancer) stage I-III
* Patient had tumor removal by breast conserving surgery or mastectomy, followed by chemotherapy (if indicated) and/or radiotherapy (if indicated)
* Patient is starting adjuvant first-line endocrine treatment with an AI alone (in postmenopausal women) or combined endocrine treatment with an AI and ovarian suppression with an LHRH-agonist (in premenopausal women)
* Patient completed the PRO Form Eligibility before registration
* Patient is fluent in German, Italian, or French
* Patient is willing to wear a wrist worn activity tracker for 24 weeks
* Female patient, age ≥ 18 years
* WHO performance status 0-2

Exclusion Criteria:

* Pre-existing severe medical conditions such as heart or lung problems or musculoskeletal conditions precluding participation in the physical activity program of moderate walking a total of 150 minutes per week as determined by the local investigator
* Mild, moderate, or severe pain (other than post-operative pain) in the last 24 hours due to muscle/joint pain on the BPI-SF single item "worst pain" ("worst pain" ≥3) within 7 days prior to registration
* Inoperable, locally advanced and/or metastatic breast cancer
* Active rheumatoid arthritis
* Neoadjuvant endocrine treatment with an AI
* NSAIDs, acetaminophen or opioids on a regular basis (\> 1 time per week)
* Concurrent participation in other clinical trials or observational studies
* Any other serious psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the intervention and follow-up or affect patient compliance with trial procedures.

Primary outcomes:
measure: Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score
timeFrame: Up to 24 weeks after randomization
Secondary outcomes:
measure: Fatigue
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: QoL: Physical scale (EORTC QLQ-C30)
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: QoL: Rose scale (EORTC QLQ-C30)
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: QoL: Emotional scale (EORTC QLQ-C30)
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: QoL: Cognitive scale (EORTC QLQ-C30)
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: QoL: Social functioning scale (EORTC QLQ-C30)
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: Nausea/Vomiting
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: Pain (EORTC QLQ-C30)
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: Global health status
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: Dyspnoea
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: Insomnia
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: Appetite loss
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: Constipation
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: Diarrhoea
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: Financial difficulties
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: Hot flashes
timeFrame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
measure: Intensity of muscle or joint pain/stiffness and its impact on everyday functioning
timeFrame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks and 1, 2 years after randomization
measure: Walking activity
timeFrame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization
measure: AI treatment adherence (diary)
timeFrame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks.
measure: AI treatment adherence (questionnaire)
timeFrame: Baseline, 12, 24 weeks and 1, 2 years after randomization
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Basel
country: Switzerland
facility: CABA - Zentrum für Onkologie, Psychologie und Bewegung
city: Basel
country: Switzerland
facility: Brustzentrum Basel - Praxis für ambulante Tumortherapie
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Bern
country: Switzerland
facility: Hirslanden Brustzentrum Bern Biel
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
city: Chur
country: Switzerland
facility: Tumorzentrum ZeTuP Chur
city: Chêne-Bougeries
country: Switzerland
facility: Clinique des Grangettes, Centre du sein
city: Frauenfeld
country: Switzerland
facility: Brustzentrum Thurgau
city: Fribourg
country: Switzerland
facility: Centre du sein Fribourg / Brustzentrum Freiburg
city: Genolier
country: Switzerland
facility: Clinique De Genolier
city: Locarno
country: Switzerland
facility: FOLM - Fondazione Oncologia Lago Maggiore
city: Lugano
country: Switzerland
facility: Oncologia Varini&Calderoni&Christinat
city: Luzerne
country: Switzerland
facility: Kantonsspital Luzern
city: Luzern
country: Switzerland
facility: Hirslanden Klinik St. Anna
city: Manno
country: Switzerland
facility: Onkologie Zentrum Spital Männedorf
city: Mendrisio
country: Switzerland
facility: Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
city: Neuenhof
country: Switzerland
facility: Hôpital Neuchâtelois
city: Olten
country: Switzerland
facility: Kantonsspital Olten
city: Rapperswil-Jona
country: Switzerland
facility: Tumorzentrum ZeTuP Rapperswil-Jona
city: Saint Gallen
country: Switzerland
facility: Brustzentrum Ostschweiz
city: Sargans
country: Switzerland
facility: Rundum Onkologie am Bahnhofpark
city: Sion
country: Switzerland
facility: Hôpital de Sion
city: St. Gallen
country: Switzerland
facility: Tumorzentrum ZeTUP
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Thun
country: Switzerland
facility: Regionalspital Thun
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur, Brustzentrum
city: Zurich
country: Switzerland
facility: Onkologie Bellevue
city: Zürich
country: Switzerland
facility: Brustzentrum Zürich
city: Zürich
country: Switzerland
facility: Universitäts Spital Zürich
Study officials:
affiliation: Tumor- und Brustzentrum ZeTuP St.Gallen
name: Friedemann Honecker, MD
role: STUDY_CHAIR
affiliation: Tumor- und Brustzentrum ZeTuP St.Gallen
name: Nicolette Hoefnagels, MSc
role: STUDY_CHAIR
References: