Clinical trial · Interventional
Adapted Physical Activity (APA) in a Breast Cancer Population.
Adapted Physical Activity (APA), Insulin Resistance, Oxidative Stress and Microcirculatory Haemodynamics in Breast Cancer Patients.
NCT03528473CI-TRIAL-00054282unknownN/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 aim of this study is to investigate the effect of a 6-months program of Adapted Physical Activity (APA) on lifestyle, physical activity levels, insulin resistance and adipokines, oxidative stress, microcirculatory haemodynamics and serum levels of specific circulating miRNA in post-menopausal, physically inactive breast cancer patients in oncologic follow-up with or without hormone therapy that had completed adjuvant treatment (radiotherapy and/or chemotherapy) . Furthermore, the study will determine the impact of APA on functional capabilities, on self-reported physical activity, quality of life and psychic health.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atherosclerosis | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Exercise | — | UNRESOLVED | — |
| Exercise Therapy | — | UNRESOLVED | — |
| Insulin Resistance | — | UNRESOLVED | — |
| Microcirculation | — | UNRESOLVED | — |
| Oxidative Stress | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise
- description
- Patients involved in the 6 months-physical training group.
- interventionNames
- Other: Exercise
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients in control group carry on their usual follow-up programme.
Primary outcomes (2)
- measure
- Change in physical activity levels
- timeFrame
- Evaluation baseline and after 6, 12 and 24 months from enrollment.
- description
- Self reported physical activity, using IPAQ-SF (International Physical Activity Questionnairev - Short Form) score
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * breast cancer patients in oncological follow-up * post-menopausal age * physically inactivity (light to moderate or vigorous leisure-time physical activity less than 10 minutes a day, US National Health Interview Survey) * assuming or not hormone therapy * after 3 months - 3 years from adjuvant post-surgical treatment (radiotherapy and/or chemotherapy) Exclusion Criteria: Permanent * Patients older than 80 years * Inability to carry on physical activity * Metastatic neoplasia or unknown stage and/or histology * Concomitant neoplasia * Patients on corticosteroid treatment * Known heart disease (heart failure NYHA II (New York Heart Association II) or superior, angina pectoris or positive exercise stress test, treatment-related cardiotoxicity) * Currently on a weight loss plan or on moderate physical activity before the start of the project (no more than three sessions a week) * Severe cachexia (loss of more than of 35% premorbid weight or weight loss more than 10% in the last 6 months). * Morbidly obesity (BMI \>40 kg/m2), * Immunodepression (absolute neutrophils count \< 500/mmc) Temporary * Uncontrolled pain or new onset bone pain until further diagnostic study * Severe anemia (haemoglobin below 8 g/dL) or platelet count lower than \<50000/μL * Fever (temperature above 38ºC) or acute infections * Severe nausea and vomiting within previous 24-36 h * Uncontrolled blood pressure (systolic blood pressure \> 160 mm Hg and/or diastolic blood pressure \>99 mm Hg)
References
Publications (5)
- BACKGROUNDAdraskela K, Veisaki E, Koutsilieris M, Philippou A. Physical Exercise Positively Influences Breast Cancer Evolution. Clin Breast Cancer. 2017 Oct;17(6):408-417. doi: 10.1016/j.clbc.2017.05.003. Epub 2017 May 19. PMID 28606800
- BACKGROUNDFoucaut AM, Berthouze-Aranda SE, Touillaud M, Kempf-Lepine AS, Baudinet C, Meyrand R, Carretier J, Bachmann P, Fervers B. Reduction of health risk factors through an adapted physical activity program in patients with breast cancer. Support Care Cancer. 2014 Apr;22(4):1097-104. doi: 10.1007/s00520-013-2065-3. Epub 2013 Dec 3. PMID 24292096
- BACKGROUNDFranses JW, Edelman ER. The evolution of endothelial regulatory paradigms in cancer biology and vascular repair. Cancer Res. 2011 Dec 15;71(24):7339-44. doi: 10.1158/0008-5472.CAN-11-1718. Epub 2011 Dec 5. PMID 22144472
- BACKGROUNDYe J, Jia J, Dong S, Zhang C, Yu S, Li L, Mao C, Wang D, Chen J, Yuan G. Circulating adiponectin levels and the risk of breast cancer: a meta-analysis. Eur J Cancer Prev. 2014 May;23(3):158-65. doi: 10.1097/CEJ.0b013e328364f293. PMID 23929213
- BACKGROUNDTesarova P, Kalousova M, Zima T, Suchanek M, Malikova I, Kvasnicka J, Duskova D, Tesar V, Vachek J, Krupickova-Kasalova Z, Malik J. Endotelial activation and flow-mediated vasodilation in young patients with breast cancer. Neoplasma. 2013;60(6):690-7. doi: 10.4149/neo_2013_088. PMID 23906304