Clinical trial · Interventional
Activity Program During Aromatase Inhibitor Therapy
A 24 Weeks Activity Program in Patients With Early Breast Cancer Receiving Aromatase Inhibitor Therapy. A Multicenter Randomized Phase III Trial
NCT03786198CI-TRIAL-00067563completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activity program | Behavioral | — | UNRESOLVED |
| Control | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- a) Home-based walking intervention
- description
- Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks + standard adjuvant AI therapy
- interventionNames
- Behavioral: Activity program
- type
- ACTIVE_COMPARATOR
- label
- b) Physical activity according to standard recommendations
- description
- 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
- interventionNames
- Behavioral: Control
Primary outcomes (1)
- measure
- Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.