Clinical trial · Interventional
Prehabilitation in Breast Cancer Surgery
Prehabilitation in Breast Cancer Surgery: A Prospective Randomized Controlled Trial Evaluating Shoulder Function, Pain, Quality of Life and Lymphedema Development
- 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, randomized, assessor-blinded, parallel-group clinical trial evaluates the effectiveness of a home-based upper extremity-focused prehabilitation program in women undergoing breast cancer surgery. Participants will be randomized 1:1 to either prehabilitation or usual care. Primary outcomes include shoulder range of motion and upper extremity function (DASH score). Secondary outcomes include grip strength, pain, fatigue, disability, anxiety/depression, and lymphedema incidence up to 2 years postoperatively.
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 (Early Breast Cancer) | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
| Cancer Rehabilitation | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Lymphedema Arm | — | UNRESOLVED | — |
| Postoperative Shoulder Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Home-Based Prehabilitation Exercise Program | Other | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prehabilitation Group
- description
- Participants will receive a structured home-based prehabilitation program delivered through written materials and instructional exercise videos (QR code access). The program includes: Aerobic training (3/week, 30-40 minutes, RPE 4-6) Upper extremity resistance exercises (3 days/week, 3 sets of 10 repetitions) Mobility and stretching exercises Adherence will be monitored through weekly remote follow-up (telephone)
- interventionNames
- Other: Home-Based Prehabilitation Exercise Program
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- Standard preoperative counseling without structured exercise prescription.
- interventionNames
- Other: Usual Care
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Women aged 18-80 Stage I-III invasive breast cancer Scheduled for surgery ≥3 weeks before surgery No neoadjuvant therapy Exclusion Criteria: Exercise contraindication Active shoulder pathology Severe cardiopulmonary disease Planned neoadjuvant therapy
References
Publications (1)
- BACKGROUNDBrahmbhatt P, Sabiston CM, Lopez C, Chang E, Goodman J, Jones J, McCready D, Randall I, Rotstein S, Santa Mina D. Feasibility of Prehabilitation Prior to Breast Cancer Surgery: A Mixed-Methods Study. Front Oncol. 2020 Sep 25;10:571091. doi: 10.3389/fonc.2020.571091. eCollection 2020. PMID 33072603