Clinical trial · Interventional
12-week Exercise Intervention Program Versus Observation in Early Stage Breast Cancer Patients on the Impact on Mental Health, Quality of Life and Immune Markers
A Randomized Controlled Study of a 12-week Exercise Intervention Program Versus Observation in Early Stage Breast Cancer Patients on the Impact on Mental Health, Quality of Life and Immune Markers
- 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)
Exercise in early breast cancer patients has the potential to improve depression, anxiety, fatigue, quality of life and even survival. The effects of exercise may come about by way of changes in weight, immune markers and telomere length, but data on this so far has not been conclusive. To better understand the physical, psychological, and biological effects of exercise on breast cancer survivorship, the investigators propose to perform a phase III randomized controlled trial of a 12-week exercise intervention program versus usual care in early stage breast cancer patients, and will follow up the patients prospectively for 5 years, with serial assessment of physical and functional activity, QoL, depression and anxiety scores, telomere length and plasma immune markers.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise intervention
- description
- Patients who are randomised to this arm will be enrolled to the exercise programme.
- interventionNames
- Behavioral: Exercise
- type
- NO_INTERVENTION
- label
- Non-exercise
- description
- Patients who are randomised to the non-exercise group can continue their daily and physical activities as they normally would.
Primary outcomes (1)
- measure
- Improved mental health
- timeFrame
- 12 months
- description
- Based on the HADS (Hospital Anxiety and Depression Scale) questionnaire, we define a score of ≥8/21 as caseness for anxiety or depression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age 21-70 years * Histological or cytological diagnosis of breast carcinoma * Stage I-III breast cancer * Has undergone curative breast cancer surgery with no clinically measurable tumor * Between 4-12 weeks from the last adjuvant radiotherapy or chemotherapy session, if given, whichever is later. Patients who do not receive adjuvant chemotherapy or radiotherapy can be enrolled and will be randomized within 4-12 weeks of breast cancer surgery. * Able to sign informed consent * Able to adhere to study procedures Exclusion Criteria: * Cardiovascular, respiratory, or musculoskeletal problems that preclude moderate physical activity * Major medical problems deemed by the investigator to be unsuitable for enrollment
References
Publications (2)
- BACKGROUNDCarayol M, Bernard P, Boiche J, Riou F, Mercier B, Cousson-Gelie F, Romain AJ, Delpierre C, Ninot G. Psychological effect of exercise in women with breast cancer receiving adjuvant therapy: what is the optimal dose needed? Ann Oncol. 2013 Feb;24(2):291-300. doi: 10.1093/annonc/mds342. Epub 2012 Oct 5. PMID 23041586
- BACKGROUNDKolden GG, Strauman TJ, Ward A, Kuta J, Woods TE, Schneider KL, Heerey E, Sanborn L, Burt C, Millbrandt L, Kalin NH, Stewart JA, Mullen B. A pilot study of group exercise training (GET) for women with primary breast cancer: feasibility and health benefits. Psychooncology. 2002 Sep-Oct;11(5):447-56. doi: 10.1002/pon.591. PMID 12228878