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Early Breast CancerNCT03786198

Activity Program During Aromatase Inhibitor Therapy

A study testing Activity program in people with Early Breast Cancer, run by Swiss Cancer Institute at 32 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Early Breast Cancer
What is being tested?
Activity program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
32 sitesSwitzerland
Study dates
28 Mar 2019to 8 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Patient is willing to wear a wrist worn activity tracker for 24 weeks
  • Female patient, age ≥ 18 years
  • WHO performance status 0-2

Who cannot join

  • 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.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Switzerland32 sites

  • Kantonsspital Aarau

    Aarau, 5001

  • Kantonsspital Baden

    Baden, 5404

  • CABA - Zentrum für Onkologie, Psychologie und Bewegung

    Basel, 4051

  • Brustzentrum Basel - Praxis für ambulante Tumortherapie

    Basel, 4052

  • Universitätsspital Basel

    Basel, CH-4031

  • Inselspital Bern

    Bern, 3010

  • Hirslanden Brustzentrum Bern Biel

    Bern, 3013

  • Clinique des Grangettes, Centre du sein

    Chêne-Bougeries, 1224

  • Kantonsspital Graubünden

    Chur, 7000

  • Tumorzentrum ZeTuP Chur

    Chur, 7000

  • Brustzentrum Thurgau

    Frauenfeld, 8501

  • Centre du sein Fribourg / Brustzentrum Freiburg

    Fribourg, 1700

  • Clinique De Genolier

    Genolier, 1272

  • FOLM - Fondazione Oncologia Lago Maggiore

    Locarno, 6600

  • Hirslanden Klinik St. Anna

    Lucerne, 6006

  • Oncologia Varini&Calderoni&Christinat

    Lugano, 6900

  • Kantonsspital Luzern

    Luzerne, CH-6000

  • Onkologie Zentrum Spital Männedorf

    Manno, 8708

  • Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

    Mendrisio, 6850

  • Hôpital Neuchâtelois

    Neuenhof, 2000

  • Kantonsspital Olten

    Olten, 4600

  • Tumorzentrum ZeTuP Rapperswil-Jona

    Rapperswil-Jona, 8640

  • Tumorzentrum ZeTUP

    Sankt Gallen, 9006

  • Brustzentrum Ostschweiz

    Sankt Gallen, 9016

  • Kantonsspital St. Gallen

    Sankt Gallen, CH-9007

  • Rundum Onkologie am Bahnhofpark

    Sargans, 7320

  • Hôpital de Sion

    Sion

  • Regionalspital Thun

    Thun, 3600

  • Kantonsspital Winterthur, Brustzentrum

    Winterthur, 8401

  • Onkologie Bellevue

    Zurich, 8001

  • Brustzentrum Zürich

    Zurich, 8008

  • Universitäts Spital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Activity program, Control
Keywords
early breast cancer, aromatase inhibitor therapy, activity program, physical activity, activity tracker, pedometer, stepcounter
Medical subject headings
Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Activity programBehavioural

    Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks

  • ControlBehavioural

    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

Study groups in NCT03786198
Study groupRoleWhat they receive
a) Home-based walking interventionExperimentalHome-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks + standard adjuvant AI therapy
Receives: Behavioral: Activity program
b) Physical activity according to standard recommendationsActive comparatorPhysical activity according to standard recommendations, wearing a wrist worn activity tracker (with no feedback about performed activity), for 24 weeks + standard adjuvant AI therapy
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 weeks after randomization

Secondary outcomes (20)

  1. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  2. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  3. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  4. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  5. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  6. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  7. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  8. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  9. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  10. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  11. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  12. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  13. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  14. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  15. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  16. 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.

    Measured: Baseline, 12 and 24 weeks and 1 and 2 years after randomization

  17. 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.

    Measured: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks and 1, 2 years after randomization

  18. Walking activity

    During trial intervention phase, daily steps will be measured by a wrist worn activity tracker.

    Measured: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization

  19. AI treatment adherence (diary)

    Adherence will be assessed by patient self-report (diary).

    Measured: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks.

  20. AI treatment adherence (questionnaire)

    Adherence will be assessed by patient self-report (questionnaire completed at visits).

    Measured: Baseline, 12, 24 weeks and 1, 2 years after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2018
  2. Study start28 Mar 2019
  3. Primary completion27 Sep 2021
  4. Study completion8 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03786198
Sponsor's protocol ID
SAKK 95/17
Status last verified
Jun 2023
First submitted
14 Dec 2018
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Activity program in people with Early Breast Cancer, run by Swiss Cancer Institute at 32 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score (time frame: Up to 24 weeks after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03786198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023; AzTrials last refreshed its copy on 3 Nov 2026.

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