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NCT Number: NCT06918184

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

Location status: Recruiting

Location contact

Mohamed ElMeligie, Ph.D

CONTACT

[email protected]

01159880001 ext. +20

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Specific Exercise Therapy

Behavioral

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 outcomes

  1. Upper Limb Function (DASH Questionnaire)

    Time frame: Assessed preoperatively (baseline) and at 6 months postoperative.

    The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire is a validated measure of upper limb function. The questionnaire is scored on a continuous scale ranging from 0 to 100, where 0 indicates no disability and 100 represents the most severe disability. Lower scores indicate better upper limb function.

Secondary outcomes

  1. Pain Intensity (Visual Analog Scale - VAS)

    Time frame: Assessed at baseline and at 1, 3, and 6 months postoperative.

    A 0-100 VAS will measure patient-reported pain levels, where 0 signifies no pain and 100 the worst pain imaginable.

  2. Wound-Related Complications - Drainage Time (Days)

    Time frame: Monitored during the immediate postoperative period up to 3 months.

    The duration of wound drainage will be recorded in days. Longer drainage time may indicate wound complications.

  3. Wound-Related Complications - Incidence of Hematoma

    Time frame: Monitored during the immediate postoperative period up to 3 months.

    The occurrence of hematoma will be documented as a binary outcome (presence or absence) for each patient. The incidence will be calculated as the proportion of patients developing hematoma during the monitoring period.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed ElMeligie, Ph.D

CONTACT

[email protected]

01159880001 ext. +20

Sponsors and collaborators

Lead sponsor

Al Hayah University In Cairo

Other

Registry information

Official study 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

Acronym: BEST-Timing

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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