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Activity Program During Aromatase Inhibitor Therapy

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ClinicalTrials.gov Identifier: NCT03786198
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : May 12, 2020
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.

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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

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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
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Contact: Daniele Oberti, PhD +41 31 389 91 91 trials@sakk.ch

Locations
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Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
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Study Chair: Friedemann Honecker, MD Tumor und Brustzentrum ZeTuP, St. Gallen
Study Chair: Nicolette Hoefnagels, MSc Tumor und Brustzentrum ZeTuP, St. Gallen
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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT03786198    
Other Study ID Numbers: SAKK 95/17
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020

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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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases