Activity Program During Aromatase Inhibitor Therapy

Early Breast Cancer Clinical Trial

Official title:

A 24 Weeks Activity Program in Patients With Early Breast Cancer Receiving Aromatase Inhibitor Therapy. A Multicenter Randomized Phase III Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03786198
• Other study ID #: SAKK 95/17
• Status: Completed
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: June 8, 2023

Study information

• Verified date: June 2023
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: June 8, 2023
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Breast Cancer

Intervention

Behavioral:
• Activity program
Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks
• Control
Physical activity according to standard recommendations, wearing a wrist worn activity tracker (with no feedback about performed activity), for 24 weeks + standard adjuvant AI therapy

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Kantonsspital Baden	Baden
Switzerland	Brustzentrum Basel - Praxis für ambulante Tumortherapie	Basel
Switzerland	CABA - Zentrum für Onkologie, Psychologie und Bewegung	Basel
Switzerland	Universitätsspital Basel	Basel
Switzerland	Hirslanden Brustzentrum Bern Biel	Bern
Switzerland	Inselspital Bern	Bern
Switzerland	Clinique des Grangettes, Centre du sein	Chêne-Bougeries
Switzerland	Kantonsspital Graubünden	Chur
Switzerland	Tumorzentrum ZeTuP Chur	Chur
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	Hirslanden Klinik St. Anna	Luzern
Switzerland	Kantonsspital Luzern	Luzerne
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	Kantonsspital St. Gallen	St. Gallen
Switzerland	Tumorzentrum ZeTUP	St. Gallen
Switzerland	Regionalspital Thun	Thun
Switzerland	Kantonsspital Winterthur, Brustzentrum	Winterthur
Switzerland	Onkologie Bellevue	Zurich
Switzerland	Brustzentrum Zürich	Zürich
Switzerland	Universitäts Spital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score	Muscle or joint pain/stiffness will be assessed at baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization by the BPI-SF questionnaire.; The BPI-SF is a 14-item self-administered questionnaire which is routinely used in clinical trials to assess pain severity and pain interference with daily activities in patients with cancer. Pain severity is assessed by four items including pain at its "worst", "least", "average" in the last 24 hours and "now" (current pain), each item being rated on a 0-10 scale.	Up to 24 weeks after randomization
Secondary	Fatigue	Fatigue will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	QoL: Physical scale (EORTC QLQ-C30)	Physical scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	QoL: Rose scale (EORTC QLQ-C30)	Role scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	QoL: Emotional scale (EORTC QLQ-C30)	Emotional scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	QoL: Cognitive scale (EORTC QLQ-C30)	Cognitive scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	QoL: Social functioning scale (EORTC QLQ-C30)	Cognitive scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	Nausea/Vomiting	Nausea/vomiting will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	Pain (EORTC QLQ-C30)	Pain will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	Global health status	Global health status will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	Dyspnoea	Dyspnoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	Insomnia	Insomnia will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	Appetite loss	Appetite loss will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	Constipation	Constipation will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	Diarrhoea	Diarrhoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	Financial difficulties	Financial difficulties will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	Hot flashes	Hot flashes will be assessed at baseline, during intervention phase and during follow-up phase via the item 37 of the EORTC QLQ BR-23.	Baseline, 12 and 24 weeks and 1 and 2 years after randomization
Secondary	Intensity of muscle or joint pain/stiffness and its impact on everyday functioning	Severity of muscle or joint pain/stiffness will be measured by the four BPI pain severity items. Pain interference will be calculated as the mean of the seven interference items.	Baseline, 3, 9, 12, 15, 18, 21, 24 weeks and 1, 2 years after randomization
Secondary	Walking activity	During trial intervention phase, daily steps will be measured by a wrist worn activity tracker.	Baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization
Secondary	AI treatment adherence (diary)	Adherence will be assessed by patient self-report (diary).	Baseline, 3, 9, 12, 15, 18, 21, 24 weeks.
Secondary	AI treatment adherence (questionnaire)	Adherence will be assessed by patient self-report (questionnaire completed at visits).	Baseline, 12, 24 weeks and 1, 2 years after randomization