Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Activity Program During Aromatase Inhibitor Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03786198
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

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.

Condition or disease Intervention/treatment Phase
Early Breast Cancer Behavioral: Activity program Behavioral: Control Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A 24 Weeks Activity Program in Patients With Early Breast Cancer Receiving Aromatase Inhibitor Therapy. A Multicenter Randomized Phase III Trial
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: a) Home-based walking intervention
Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks + standard adjuvant AI therapy
Behavioral: Activity program
Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks

Active Comparator: b) Physical activity according to standard recommendations
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
Behavioral: 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




Primary Outcome Measures :
  1. 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 ]

    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.



Secondary Outcome Measures :
  1. Fatigue [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  2. QoL: Physical scale (EORTC QLQ-C30) [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  3. QoL: Rose scale (EORTC QLQ-C30) [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  4. QoL: Emotional scale (EORTC QLQ-C30) [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  5. QoL: Cognitive scale (EORTC QLQ-C30) [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  6. QoL: Social functioning scale (EORTC QLQ-C30) [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  7. Nausea/Vomiting [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  8. Pain (EORTC QLQ-C30) [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  9. Global health status [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  10. Dyspnoea [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  11. Insomnia [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  12. Appetite loss [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  13. Constipation [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  14. Diarrhoea [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  15. Financial difficulties [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  16. Hot flashes [ Time Frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization ]
    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.

  17. Intensity of muscle or joint pain/stiffness and its impact on everyday functioning [ Time Frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks and 1, 2 years after randomization ]
    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.

  18. Walking activity [ Time Frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization ]
    During trial intervention phase, daily steps will be measured by a wrist worn activity tracker.

  19. AI treatment adherence (diary) [ Time Frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks. ]
    Adherence will be assessed by patient self-report (diary).

  20. AI treatment adherence (questionnaire) [ Time Frame: Baseline, 12, 24 weeks and 1, 2 years after randomization ]
    Adherence will be assessed by patient self-report (questionnaire completed at visits).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786198


Contacts
Layout table for location contacts
Contact: Daniele Oberti, PhD +41 31 389 91 91 trials@sakk.ch

Locations
Layout table for location information
Switzerland
Kantonsspital Aarau Recruiting
Aarau, Switzerland, 5001
Contact: Dimitri Sarlos, MD    +41 62 838 50 65    Dimitri.Sarlos@ksa.ch   
Principal Investigator: Dimitri Sarlos, MD         
Kantonsspital Baden Recruiting
Baden, Switzerland, 5404
Contact: Cornelia Leo, MD    +41 56 486 21 11    cornelia.leo@ksb.ch   
Principal Investigator: Cornelia Leo, MD         
CABA - Zentrum für Onkologie, Psychologie und Bewegung Recruiting
Basel, Switzerland, 4051
Contact: Cathrine Balmelli, MD    +41 61 511 25 40    c.balmelli@caba-basel.ch   
Principal Investigator: Cathrine Balmelli, MD         
Brustzentrum Basel - Praxis für ambulante Tumortherapie Recruiting
Basel, Switzerland, 4052
Contact: David Roger Thorn, MD    +41 61 279 98 22    dr.david.thorn@hin.ch   
Principal Investigator: David Roger Thorn, MD         
Universitätsspital Basel Recruiting
Basel, Switzerland, CH-4031
Contact: Marcus Vetter, MD    +41 61 265 25 25    marcus.vetter@usb.ch   
Principal Investigator: Marcus Vetter, MD         
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli Recruiting
Bellinzona, Switzerland, 6500
Contact: Olivia Pagani, MD    +41 91 811 84 35    olivia.pagani@ibcsg.org   
Principal Investigator: Olivia Pagani, MD         
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Julian Wampfler, MD    +41 31 632 41 14    julian.wampfler@insel.ch   
Principal Investigator: Julian Wampfler, MD         
Kantonsspital Graubünden Recruiting
Chur, Switzerland, 7000
Contact: Michael Schwitter, MD    +41 81 256 75 68    michael.schwitter@ksgr.ch   
Principal Investigator: Michael Schwitter, MD         
Tumorzentrum ZeTuP Chur Recruiting
Chur, Switzerland, 7000
Contact: Katja Zirlik, Prof    +41 81 257 01 30    katja.zirlik@zetup.ch   
Principal Investigator: Katja Zirlik, Prof         
Clinique des Grangettes, Centre du sein Recruiting
Chêne-Bougeries, Switzerland, 1224
Contact: Mahbiz Nobahar Corke, MD    +41 22 545 80 06    mahbiz.nobahar@grangettes.ch   
Principal Investigator: Mahbiz Nobahar Corke, MD         
Brustzentrum Thurgau Recruiting
Frauenfeld, Switzerland, 8501
Contact: Mathias Fehr, Prof    +41 52 723 72 56    mathias.fehr@stgag.ch   
Principal Investigator: Mathias Fehr, Prof         
Centre du sein Fribourg / Brustzentrum Freiburg Recruiting
Fribourg, Switzerland, 1700
Contact: Laurent Rosset, MD    +41 26 347 43 07    rossetl@hin.ch   
Principal Investigator: Laurent Rosset, MD         
Clinique De Genolier Recruiting
Genolier, Switzerland, 1272
Contact: Volker Kirchner, MD    +41 22 366 94 42    vkirchner@genolier.net   
Principal Investigator: Volker Kirchner, MD         
FOLM - Fondazione Oncologia Lago Maggiore Recruiting
Locarno, Switzerland, 6600
Contact: Michail Kouros, MD    +41 91 751 82 30    mk@pedrazzini-kouros.ch   
Principal Investigator: Michail Kouros, MD         
Oncologia Varini&Calderoni&Christinat Recruiting
Lugano, Switzerland, 6900
Contact: Antonello Calderoni, MD    +41 91 922 69 88    antonello.calderoni@swissoncology.com   
Principal Investigator: Antonello Calderoni, MD         
Kantonsspital Luzern Recruiting
Luzerne, Switzerland, CH-6000
Contact: Stefan Aebi, Prof    +41 41 205 58 60    stefan.aebi@onkologie.ch   
Principal Investigator: Stefan Aebi, Prof         
Hirslanden Klinik St. Anna Recruiting
Luzern, Switzerland, 6006
Contact: Peter Dubsky, MD    +41 41 208 37 53    peter.dubsky@hirslanden.ch   
Principal Investigator: Peter Dubsky, MD         
Onkologie Zentrum Spital Männedorf Recruiting
Manno, Switzerland, 8708
Contact: Andreas Hochstrasser, MD    +41 44 922 30 00    a.hochstrasser@spital.maennedorf.ch   
Principal Investigator: Andreas Hochstrasser, MD         
Hôpital Neuchâtelois Recruiting
Neuenhof, Switzerland, 2000
Contact: Amina Chouiter-Djebaili, MD    +41 32 713 30 00    amina-faiza.chouiter-djebaili@h-ne.ch   
Principal Investigator: Amina Chouiter-Djebaili, MD         
Kantonsspital Olten Recruiting
Olten, Switzerland, 4600
Contact: Catrina Uhlmann Nussbaum, MD    +41 62 311 42 41    cuhlmann_ol@spital.ktso.ch   
Principal Investigator: Catrina Uhlmann Nussbaum, MD         
Tumorzentrum ZeTuP Rapperswil-Jona Recruiting
Rapperswil-Jona, Switzerland, 8640
Contact: Matthias Egger, MD    +41 55 536 13 00    matthias.egger@zetup.ch   
Principal Investigator: Matthias Egger, MD         
Brustzentrum Ostschweiz Recruiting
Saint Gallen, Switzerland, 9016
Contact: Patrik Weder, MD    +41 71 552 33 33    patrik.weder@bz-ost.ch   
Principal Investigator: Patrik Weder         
Rundum Onkologie am Bahnhofpark Recruiting
Sargans, Switzerland, 7320
Contact: Stefan Greuter, MD    +41 81 720 06 20    rundum@hin.ch   
Principal Investigator: Stefan Greuter, MD         
Hôpital de Sion Recruiting
Sion, Switzerland
Contact: Véronique Membrez, MD    +41 27 603 48 53    veronique.membrez@hopitalvs.ch   
Principal Investigator: Véronique Membrez, MD         
Tumorzentrum ZeTUP Recruiting
St. Gallen, Switzerland, 9006
Contact: Friedemann Honecker, MD    +41 71 243 00 43    friedemann.honecker@zetup.ch   
Principal Investigator: Friedemann Honecker, MD         
Kantonsspital St. Gallen Recruiting
St. Gallen, Switzerland, CH-9007
Contact: Salome Riniker, MD    +41 71 494 19 77    salome.riniker@kssg.ch   
Principal Investigator: Salome Riniker, MD         
Regionalspital Thun Recruiting
Thun, Switzerland, 3600
Contact: Daniel Rauch, MD    +41 33 226 26 45    daniel.rauch@spitalstsag.ch   
Principal Investigator: Daniel Rauch, MD         
Kantonsspital Winterthur, Brustzentrum Recruiting
Winterthur, Switzerland, 8401
Contact: Andreas Müller, MD    +41 52 266 25 52    andreas.mueller@ksw.ch   
Principal Investigator: Andreas Müller, MD         
Onkologie Bellevue Recruiting
Zurich, Switzerland, 8001
Contact: Basil A. Bättig, MD    +41 44 261 61 11    bbaettig@hin.ch   
Principal Investigator: Basil A. Bättig, MD         
Brustzentrum Zürich Recruiting
Zürich, Switzerland, 8008
Contact: Uwe Güth, Prof    +41 44 380 76 60    u.gueth@brust-zentrum.ch   
Principal Investigator: Uwe Güth, Prof         
Universitäts Spital Zürich Recruiting
Zürich, Switzerland, 8091
Contact: Konstantin Dedes, MD    +41 44 255 11 11    konstantin.dedes@usz.ch   
Principal Investigator: Konstantin Dedes, MD         
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Layout table for investigator information
Study Chair: Friedemann Honecker, MD Tumor und Brustzentrum ZeTuP, St. Gallen
Study Chair: Nicolette Hoefnagels, MSc Tumor und Brustzentrum ZeTuP, St. Gallen

Layout table for additonal information
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT03786198     History of Changes
Other Study ID Numbers: SAKK 95/17
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swiss Group for Clinical Cancer Research:
early breast cancer
aromatase inhibitor therapy
activity program
physical activity
activity tracker
pedometer
stepcounter

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs