Clinical trial · Interventional
Prehabilitation of Breast Cancer-Related Lymphedema
Physical Prehabilitation of Breast Cancer-Related Lymphedema
- 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 prospective prehabilitation study aims to evaluate the effects of an individualized exercise program initiated before breast cancer surgery and continued for 12 months postoperatively. The intervention focuses on incidence of breast cancer-related lymphedema, improving functional outcomes, range of motion, pain, and patient-reported measures throughout the surgical and recovery phases. Participants receive structured, personalized exercise instructions and are monitored regularly during follow-up. The study assesses the trajectory of extremity volume difference, early postoperative pain, the recovery pattern of shoulder range of motion and changes in functional status across the first postoperative year. Additionally, it examines the incidence of lymphedema and explores demographic and clinical determinants affecting patient outcomes. The findings are expected to provide evidence for the integration of prehabilitation into standard breast cancer care pathways.
Conditions
Conditions (4)
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-Related Arm Lymphedema | — | UNRESOLVED | — |
| Fatigue Syndrome, Chronic | — | UNRESOLVED | — |
| Prehabilitation | — | UNRESOLVED | — |
| Quality of Life Impairment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation Exercise Group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Prehabilitation Exercise Group
- description
- Behavioral Intervention
- interventionNames
- Behavioral: Prehabilitation Exercise Group
Primary outcomes (3)
- measure
- Incidence of Lymphedema Development
- timeFrame
- Baseline; 1, 3, 6, and 12 months postoperatively
- description
- Lymphedema is determined by volume differences between extremities and physical signs of edema. Physical examination consists of inspection of the patient for swelling, rash, dermal ulcerations, hyperkeratosis, vascular signs continuing with palpation for pitting and Stemmer's sign. Limb circumferences were measured using a constant-tension tape beginning from the ulnar styloid process in the upper extremity with 4 cm intervals up to 32 cm. Afterwards limb volume was estimated via calculator model. Calculation results are compared by opposite limb and volume difference of 200 ml or 5-10% is considered as Lymphedema. Clinical severity was graded according to the International Society of Lymphology (ISL) staging system (Stages 0-III), based on presence of swelling, reversibility, pitting, and tissue fibrosis.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18 years or older * Diagnosed with breast cancer and scheduled for surgical treatment * Able to perform prescribed upper-extremity exercises * Able to provide informed consent and complete follow-up assessments. Exclusion Criteria: * Presence of metastatic disease at baseline * Neurological, orthopedic, or systemic conditions limiting upper-extremity mobility * Prior breast or axillary surgery on the same side * Planned neoadjuvant chemotherapy that would delay the initiation of the exercise program * Inability to comply with the exercise instruction or follow-up schedule
References
Publications (2)
- RESULTToohey K, Hunter M, McKinnon K, Casey T, Turner M, Taylor S, Paterson C. A systematic review of multimodal prehabilitation in breast cancer. Breast Cancer Res Treat. 2023 Jan;197(1):1-37. doi: 10.1007/s10549-022-06759-1. Epub 2022 Oct 21. PMID 36269525
- RESULTDel Bianco N, Borsati A, Toniolo L, Ciurnielli C, Belluomini L, Insolda J, Sposito M, Milella M, Schena F, Pilotto S, Avancini A. What is the role of physical exercise in the era of cancer prehabilitation? A systematic review. Crit Rev Oncol Hematol. 2024 Jun;198:104350. doi: 10.1016/j.critrevonc.2024.104350. Epub 2024 Apr 18. PMID 38642726