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Recruiting NCT06918184

Timing of Specific Exercise Therapy After Breast Cancer Surgery: Early Versus Delayed Initiation

No phase Interventional Breast Cancer

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: Specific Exercise Therapy.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 65 years · All.
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
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Timing of Specific Exercise Therapy After Breast Cancer Surgery: A Single-Center, Parallel-Group Randomized Controlled Trial Comparing Early (<1 Week Postoperative) Versus Delayed (3 Weeks Postoperative) Initiation for Optimized Upper Limb Function

Overview

This single-center, parallel-group randomized controlled trial (RCT) will compare two timings for initiating specific exercise therapy after breast cancer surgery. The study tests whether early initiation (within the first postoperative week) versus delayed initiation (at 3 weeks postoperative) results in superior upper limb function at 6 months as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Secondary outcomes include pain intensity (Visual Analog Scale, VAS) and wound-related complications such as drainage time and hematoma incidence.

Interventions

  • Behavioral Specific Exercise Therapy
    The exercise protocol includes mobilisation and stretching with 40-minute sessions twice weekly for 8 weeks post-initiation, transitioning to a home-based maintenance phase for 4 months. All sessions will be supervised by certified physiotherapists.

Primary outcome measures

  • Upper Limb Function (DASH Questionnaire) [Time frame: Assessed preoperatively (baseline) and at 6 months postoperative.]
Secondary outcome measures (3)
  • Pain Intensity (Visual Analog Scale - VAS) [Time frame: Assessed at baseline and at 1, 3, and 6 months postoperative.]
  • Wound-Related Complications - Drainage Time (Days) [Time frame: Monitored during the immediate postoperative period up to 3 months.]
  • Wound-Related Complications - Incidence of Hematoma [Time frame: Monitored during the immediate postoperative period up to 3 months.]

Eligibility criteria

Inclusion criteria

  • Women aged 18-65 years.
  • Scheduled to undergo breast cancer surgery with axillary node dissection.
  • At risk for upper limb morbidity based on preoperative assessment.
  • Able to provide informed consent and complete study questionnaires.
  • Willing and able to attend scheduled physiotherapy sessions and follow-up evaluations.

Exclusion criteria

  • Diagnosis of recurrent or metastatic breast cancer.
  • Concurrent participation in another rehabilitation intervention or clinical trial.
  • Severe comorbidities (e.g., uncontrolled cardiovascular disease, severe orthopedic conditions) that preclude safe participation.
  • History of previous shoulder surgery or chronic upper extremity musculoskeletal disorders unrelated to breast cancer treatment.
  • Inability to understand or complete study materials in English.
  • Pregnancy or lactation.

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
Treatment

Study locations

Egypt · 1 center
  • Faculty of Physical Therapy, Al Hayah University — Cairo

Identifiers

NCT: NCT06918184 · BCExTiming2025-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗