Timing of Specific Exercise Therapy After Breast Cancer Surgery: Early Versus Delayed Initiation (BEST-Timing)

Al Hayah University In Cairo

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Specific Exercise Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06918184

BCExTiming2025-02

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

140 participants in 2 patient groups

Early Initiation of Specific Exercise Therapy

Experimental group

Description:

In this group, participants will initiate specific exercise therapy within the first postoperative week. They will receive 40-minute supervised sessions twice weekly for 8 weeks, with a transition to a prescribed home-based maintenance program for an additional 4 months.

Treatment:

Behavioral: Specific Exercise Therapy

Delayed Initiation of Specific Exercise Therapy

Experimental group

Description:

Participants in this group will begin the same specific exercise therapy protocol at 3 weeks postoperative. Otherwise, the intervention is identical to that provided to the Early Therapy group.

Treatment:

Behavioral: Specific Exercise Therapy