Breast CancerBEST-TimingNCT06918184
Timing of Specific Exercise Therapy After Breast Cancer Surgery: Early Versus Delayed Initiation
A study testing Specific Exercise Therapy in people with Breast Cancer, run by Al Hayah University In Cairo at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Specific Exercise Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2025to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Al Hayah University
Cairo, 12311
Mohamed ElMeligie, Ph.D, 01159880001 ext. +20, mohamed.elmeligie@ahuc.edu.eg
About this study
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
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.
- Conditions
- Breast Cancer
- Being tested
- Specific Exercise Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific Exercise TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Initiation of Specific Exercise Therapy | Experimental | 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. Receives: Behavioral: Specific Exercise Therapy |
| Delayed Initiation of Specific Exercise Therapy | Experimental | 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. Receives: Behavioral: Specific Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Limb Function (DASH Questionnaire)
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.
Measured: Assessed preoperatively (baseline) and at 6 months postoperative.
Secondary outcomes (3)
Pain Intensity (Visual Analog Scale - VAS)
A 0-100 VAS will measure patient-reported pain levels, where 0 signifies no pain and 100 the worst pain imaginable.
Measured: Assessed at baseline and at 1, 3, and 6 months postoperative.
Wound-Related Complications - Drainage Time (Days)
The duration of wound drainage will be recorded in days. Longer drainage time may indicate wound complications.
Measured: Monitored during the immediate postoperative period up to 3 months.
Wound-Related Complications - Incidence of Hematoma
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.
Measured: Monitored during the immediate postoperative period up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayah University In Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918184
- Sponsor's protocol ID
- BCExTiming2025-02
- Acronym
- BEST-Timing
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06918184
- Acronym / sponsor ID
- BEST-Timing / BCExTiming2025-02
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Al Hayah University In CairoUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early Initiation of Specific Exercise Therapy | Experimental | Behavioral: Specific Exercise TherapyIn 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. |
| Delayed Initiation of Specific Exercise Therapy | Experimental | Behavioral: Specific Exercise TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific Exercise TherapyThe 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. | Behavioural | Delayed Initiation of Specific Exercise Therapy, Early Initiation of Specific Exercise Therapy |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific Exercise Therapy in people with Breast Cancer, run by Al Hayah University In Cairo at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed ElMeligie, Ph.D (01159880001 ext. +20, mohamed.elmeligie@ahuc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Limb Function (DASH Questionnaire) (time frame: Assessed preoperatively (baseline) and at 6 months postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.