Clinical trial · Interventional
Exercise Training in Postmenopausal Patients With Breast Cancer
Randomized Trial of Exercise Training in Postmenopausal Patients With Hormone-receptor Positive Breast Cancer Undergoing Treatment With Aromatase Inhibitors
- 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)
This randomized trial aims to assess if a well defined subgroup of breast cancer patients benefit from a controlled physical activity program. All patients will be screened for their physical ability to complete the interventional exercise program. Only patients capable and willing to take part in this study and meeting all inclusion and exclusion criteria will be randomized. All patients are to receive identical counseling for ideal nutritional, life-style and physical activity. Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home.
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 |
|---|---|---|---|
| Physical Activity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Counseling | Behavioral | — | UNRESOLVED |
| physical activity | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Counseling
- description
- Patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity.
- interventionNames
- Behavioral: Counseling
- type
- EXPERIMENTAL
- label
- Controlled physical activity
- description
- All patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity. Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home.
- interventionNames
- Behavioral: physical activity
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Postmenopausal women with hormone receptor positive breast cancer (as defined by HR \>= ++ and/or PR \>= ++) who are treated with aromatase inhibitors * ECOG performance status \<= 2 * all age groups Exclusion Criteria: * Pathologic ergometry * Uncontrolled diabetes mellitus * Uncontrolled hypertension * COPD \> II * Active opportunistic infection * NYHA heart failure III or IV
References
Publications (1)
- DERIVEDWestphal T, Rinnerthaler G, Gampenrieder SP, Niebauer J, Thaler J, Pfob M, Fuchs D, Riedmann M, Mayr B, Reich B, Melchardt T, Mlineritsch B, Pleyer L, Greil R. Supervised versus autonomous exercise training in breast cancer patients: A multicenter randomized clinical trial. Cancer Med. 2018 Dec;7(12):5962-5972. doi: 10.1002/cam4.1851. Epub 2018 Nov 10. PMID 30415507