Status:
COMPLETED
Activity Program During Aromatase Inhibitor Therapy
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Early Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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) th...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2023
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT03786198
Start Date
March 28 2019
End Date
June 8 2023
Last Update
June 27 2023
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
Kantonsspital Aarau
Aarau, Switzerland, 5001
2
Kantonsspital Baden
Baden, Switzerland, 5404
3
CABA - Zentrum für Onkologie, Psychologie und Bewegung
Basel, Switzerland, 4051
4
Brustzentrum Basel - Praxis für ambulante Tumortherapie
Basel, Switzerland, 4052