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Activity Program During Aromatase Inhibitor Therapy

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ClinicalTrials.gov Identifier: NCT03786198
Recruitment Status : Active, not recruiting
First Posted : December 24, 2018
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Tracking Information
First Submitted Date  ICMJE December 14, 2018
First Posted Date  ICMJE December 24, 2018
Last Update Posted Date July 26, 2021
Actual Study Start Date  ICMJE March 28, 2019
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • AI treatment adherence (diary) [ Time Frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks. ]
    Adherence will be assessed by patient self-report (diary).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Activity Program During Aromatase Inhibitor Therapy
Official Title  ICMJE A 24 Weeks Activity Program in Patients With Early Breast Cancer Receiving Aromatase Inhibitor Therapy. A Multicenter Randomized Phase III Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Early Breast Cancer
Intervention  ICMJE
  • Behavioral: Activity program
    Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks
  • 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
Study Arms  ICMJE
  • Experimental: a) Home-based walking intervention
    Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks + standard adjuvant AI therapy
    Intervention: Behavioral: Activity program
  • 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
    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 4, 2020)
375
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2018)
350
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03786198
Other Study ID Numbers  ICMJE SAKK 95/17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Swiss Group for Clinical Cancer Research
Study Sponsor  ICMJE Swiss Group for Clinical Cancer Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Friedemann Honecker, MD Tumor und Brustzentrum ZeTuP, St. Gallen
Study Chair: Nicolette Hoefnagels, MSc Tumor und Brustzentrum ZeTuP, St. Gallen
PRS Account Swiss Group for Clinical Cancer Research
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP