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Not yet recruiting NCT07425379

Prehabilitation in Breast Cancer Surgery

No phase Interventional Breast Cancer (Early Breast Cancer) Postoperative Shoulder Dysfunction Lymphedema Arm Cancer Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home-Based Prehabilitation Exercise Program, Usual Care.
Who it may be relevant to
Registry conditions: Breast Cancer (Early Breast Cancer), Postoperative Shoulder Dysfunction, Lymphedema Arm, Cancer Rehabilitation. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prehabilitation in Breast Cancer Surgery: A Prospective Randomized Controlled Trial Evaluating Shoulder Function, Pain, Quality of Life and Lymphedema Development

Overview

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.

Detailed description

Breast cancer surgery is associated with postoperative morbidity including shoulder dysfunction, pain, fatigue, and lymphedema. Prehabilitation aims to optimize functional capacity before surgery and may reduce postoperative complications.

This single-center randomized controlled trial will enroll 54 women with stage I-III invasive breast cancer scheduled for mastectomy or breast-conserving surgery. Participants will be randomized to:

1. Home-based structured prehabilitation program 2. Usual preoperative care

Primary endpoints are shoulder range of motion (goniometric measurement) and DASH score changes across multiple time points. Participants will be followed for up to 24 months for lymphedema development.

Interventions

  • Other Home-Based Prehabilitation Exercise Program
    Participants assigned to this arm will receive a structured, home-based prehabilitation program initiated at least three weeks prior to surgery. The intervention includes: (1) moderate-intensity aerobic exercise (3 sessions per week, 30 minutes per session, target intensity RPE 4-6/10), (2) upper extremity resistance exercises using elastic bands (3 sessions per week, 3 sets of 10 repetitions per exercise), and (3) mobility and stretching exercises focused on shoulder function. The program will
  • Other Usual Care
    Usual Preoperative Care

Primary outcome measures

  • Change in Shoulder Range of Motion (degrees) [Time frame: Baseline to 12 weeks post-op]
  • DASH Score [Time frame: Baseline to 12 weeks post-op]
Secondary outcome measures (6)
  • Grip Strength [Time frame: Baseline to 12 weeks post-op]
  • Pain (Brief Pain Inventory - BPI) [Time frame: baseline to 12 weeks]
  • Fatigue (Functional Assessment of Cancer Therapy - Fatigue; FACT-F) [Time frame: 0-12 months]
  • Disability (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0) [Time frame: baseline to 12 weeks]
  • Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS) [Time frame: baseline to 12 weeks]
  • Lymphedema Incidence [Time frame: baseline to 2 years postop]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Dr. Sadi Konuk Bakirkoy Training and Health Hospital — Istanbul

Publications

  • Brahmbhatt 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

Identifiers

NCT: NCT07425379 · Dr. Sadi Konuk Bakirkoy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗