Clinical trial NCT06918184: Timing of Specific Exercise Therapy After Breast Cancer Surgery: Early Versus Delayed Initiation
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Al Hayah University In Cairo
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible women will be randomly assigned to either the early or delayed specific exercise therapy initiation group. The interventions will be identical aside from the timing; both groups will receive supervised exercise sessions and subsequent home maintenance.
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Upper Limb Function (DASH Questionnaire)
timeFrame: Assessed preoperatively (baseline) and at 6 months postoperative.
Secondary outcomes:
measure: Pain Intensity (Visual Analog Scale - VAS)
timeFrame: Assessed at baseline and at 1, 3, and 6 months postoperative.
measure: Wound-Related Complications - Drainage Time (Days)
timeFrame: Monitored during the immediate postoperative period up to 3 months.
measure: Wound-Related Complications - Incidence of Hematoma
timeFrame: Monitored during the immediate postoperative period up to 3 months.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Al Hayah University
Study officials:
References: