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

April 5, 2025 updated by: Al Hayah University In Cairo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 12311
        • Recruiting
        • Faculty of Physical Therapy, Al Hayah University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Initiation of Specific Exercise Therapy
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.
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.
Experimental: Delayed Initiation of Specific Exercise Therapy
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed preoperatively (baseline) and at 6 months postoperative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
The duration of wound drainage will be recorded in days. Longer drainage time may indicate wound complications.
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.
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.
Monitored during the immediate postoperative period up to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al Hayah University In Cairo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2025

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

March 30, 2025

First Submitted That Met QC Criteria

April 5, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCExTiming2025-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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