Clinical trial · Interventional
Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC)
- 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)
To improve the health and quality of life of breast cancer (BC) patients, researchers are focusing on prehabilitation strategies like physical exercise, preparing patients both mentally and physically for clinical and surgical procedures, potentially reducing complications. Physical exercise is also recognized as pivotal in optimizing chemotherapy. It can improve blood flow and oxygen supply in the microenvironment of the tumor (MT), potentially enhancing chemotherapy effectiveness. Although previous research has shown the benefits of preoperative exercise combined with chemotherapy in various cancer types, including BC, further investigation is needed into the exact effects of prehabilitation exercise (PE) on MT physiology. This study aims to provide valuable insights into the potential benefits of PE for BC patients and its impact on the tumor microenvironment. The hypothesis is that PE in BC patients will improve their quality of life, reduce fatigue, increase muscle mass, decrease fat mass, and enhance physical fitness. Additionally, beneficial acute hemodynamic changes, particularly increased blood flow following PE sessions, and hemodynamic adaptations involving higher levels of oxygenated hemoglobin, increased blood flow, greater oxygen saturation, and a higher metabolic rate of oxygen, are expected. The study will include 76 participants aged 18-65 years, meeting specific criteria such as a diagnosis of hormone receptor-positive BC, no medical contraindications for exercise, no metastatic cancer, and no structured exercise in the last six months. These participants will be randomly assigned to a PE group or a control group. The study will consist of three phases: Phase 1 involves pre-intervention assessments, Phase 2 includes a 4-week PE intervention with three weekly sessions, and Phase 3 encompasses post-intervention and post-surgery assessments. The 4-week PE intervention in Phase 2 will include strength and aerobic training. Quality of life and fatigue assessments will use questionnaires, and measurements will be made for fat mass, lean mass, bone density, and cardiorespiratory fitness. Strength measurements will be taken, and shoulder mobility will be evaluated. Hemodynamics of the MT will be assessed using a hybrid device combining Near-Infrared Spectroscopy and Diffuse Correlation Spectroscopy with ultrasound.
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 |
|---|---|---|---|
| Prehabilitation exercise program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PEP group
- description
- Breast cancer patients involved in a prehabilitation physical exercise program
- interventionNames
- Behavioral: Prehabilitation exercise program
- type
- NO_INTERVENTION
- label
- CON group
- description
- Breast cancer patients not involved in a prehabilitation physical exercise program
Primary outcomes (14)
- measure
- Quality of life score
- timeFrame
- 0, 28,and 35 days
- description
- Quality of life will be assessed using the 'European Organisation for Research and Treatment of Cancer Quality ofLife Questionnaire' (EORTC QLQ-C30). This questionnaire has three different scales: (1) Global health status with 2 items scored from 1 to 7, (2) Functional scales with 15 items scored from 1 to 4, and (3) Symptom scales with 13 items scored from 1 to 4. All of the raw scores from the scales are transformed to values from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a healthy level of functioning, a high score for the global health status represents a high quality of life, but a high score for a symptom scale represents a high level of symptomatology.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Be aged between 18 and 65 years. * Have a diagnosis of hormone receptor-positive breast cancer (ER and PR). * Have no medical contraindications that prevent them from participating in physical exercise. * Have four weeks period between diagnosis and surgery Exclusion Criteria: * Being diagnosed of another primary and/or secondary tumor or being in metastatic stage. * Presence of uncontrolled serious medical illness * Presence of any medical, psychological or social problem that could seriously interfere with the patient's participation in the study * Those who have engaged in structured physical exercise in the last 6 months.
References
Publications (30)
- BACKGROUNDChong F, Wang Y, Song M, Sun Q, Xie W, Song C. Sedentary behavior and risk of breast cancer: a dose-response meta-analysis from prospective studies. Breast Cancer. 2021 Jan;28(1):48-59. doi: 10.1007/s12282-020-01126-8. Epub 2020 Jun 30. PMID 32607943
- BACKGROUNDLee K, Kruper L, Dieli-Conwright CM, Mortimer JE. The Impact of Obesity on Breast Cancer Diagnosis and Treatment. Curr Oncol Rep. 2019 Mar 27;21(5):41. doi: 10.1007/s11912-019-0787-1. PMID 30919143
- BACKGROUNDGillis C, Loiselle SE, Fiore JF Jr, Awasthi R, Wykes L, Liberman AS, Stein B, Charlebois P, Carli F. Prehabilitation with Whey Protein Supplementation on Perioperative Functional Exercise Capacity in Patients Undergoing Colorectal Resection for Cancer: A Pilot Double-Blinded Randomized Placebo-Controlled Trial. J Acad Nutr Diet. 2016 May;116(5):802-12. doi: 10.1016/j.jand.2015.06.007. Epub 2015 Jul 21. PMID 26208743
- BACKGROUNDSanta Mina D, Hilton WJ, Matthew AG, Awasthi R, Bousquet-Dion G, Alibhai SMH, Au D, Fleshner NE, Finelli A, Clarke H, Aprikian A, Tanguay S, Carli F. Prehabilitation for radical prostatectomy: A multicentre randomized controlled trial. Surg Oncol. 2018 Jun;27(2):289-298. doi: 10.1016/j.suronc.2018.05.010. Epub 2018 May 7. PMID 29937184
- BACKGROUNDSebio Garcia R, Yanez Brage MI, Gimenez Moolhuyzen E, Granger CL, Denehy L. Functional and postoperative outcomes after preoperative exercise training in patients with lung cancer: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):486-97. doi: 10.1093/icvts/ivw152. Epub 2016 May 25. PMID 27226400
- BACKGROUNDBozzetti F. Forcing the vicious circle: sarcopenia increases toxicity, decreases response to chemotherapy and worsens with chemotherapy. Ann Oncol. 2017 Sep 1;28(9):2107-2118. doi: 10.1093/annonc/mdx271. PMID 28911059
- Lipsett A, Barrett S, Haruna F, Mustian K, O'Donovan A. The impact of exercise during adjuvant radiotherapy for breast cancer on fatigue and quality of life: A systematic review and meta-analysis. Breast. 2017 Apr;32:144-155. doi: 10.1016/j.breast.2017.02.002. Epub 2017 Feb 9.