MastectomyNCT07447024
Selected Exercise Program on Upper Cross Syndrome Post-unilateral Mastectomy
A study testing Selected exercise program and Routine medical therapy in people with Mastectomy, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to evaluate the therapeutic efficacy of exercise rehabilitation program on upper limb range and forward head posture post unilateral radical mastectomy. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Mastectomy
- What is being tested?
- Selected exercise program and Routine medical therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2026to 15 Jun 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject selection will be according to the following criteria:
- Age range between 45-65years.
- Females only will participate in the study.
- All patients have upper cross syndrome post-unilateral modified radical mastectomy
- All patients relatives enrolled the study will have their informed consent.
Who cannot join
- Age more than 65 years or less than45 years.
- Subjects who have hearing problems
- Patients have acute viral diseases, acute tuberculosis, mental disorders or those with pacemakers.
- Diabetic, cardiac and renal patients.
- Genetic disease
- Patients who had any other breast cancer operations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of the study is to evaluate the therapeutic efficacy of exercise rehabilitation program on upper limb range and forward head posture post unilateral radical mastectomy.
Read the detailed description
Upper cross syndrome (forward head posture and rounded shoulder) is a major problem facing physical therapist, which causes an increase in pain, limitation of quality of life and delayed rehabilitation process.
The lack in knowledge and information in the published studies about effects of exercise program in forward head posture and rounded shoulder in female's management post unilateral mastectomy. This study will be carried out to investigate the effectiveness exercise program in improving the range of motion in shoulder and forward head posture in females post unilateral mastectomy.
- Conditions
- Mastectomy
- Being tested
- Selected exercise program, Routine medical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selected exercise programOther
Also called Exercise program
Patients who have upper cross syndrome post unilateral modified radical mastectomy and who will receive exercise program (strengthening, active range of motion exercise, and strengthening exercises including prone scapular stabilization, shoulders shrug McKenzie exercise for neck, repeated shoulder horizontal adduction, repeated shoulder flexion, repeated shoulder extension, neck flexion McKenzie exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12weeks, time of session is 45 minutes.
Routine medical therapyDrug
For pain relief:
Acetaminophen: 2 pills two times per day. Ibuprofen 400 mg: 1 pill two times per day.
Hormonal therapy:
Tamoxifen 20 mg: once daily. Silicone gel creams (Biocorneum): 3 times per day. These medications will be given for all patients throughout the treatment period (12 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Selected exercise program group | Experimental | Patient will receive exercise program (stretching, strengthening and active range of motion (ROM) exercise) and routine medical treatment for 12 weeks. Receives: Other: Selected exercise program; Drug: Routine medical therapy |
| Routine medical treatment | Active comparator | Patients will receive routine medical treatment only for 12 weeks. Receives: Drug: Routine medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craniovertebral angle (CVA)
The Craniovertebral angle (CVA) is measured by creating an angle between a horizontal line passing through the seventh cervical (C7) vertebra and a line connecting C7 to the tragus of the ear. It is commonly used to assess forward head posture, with smaller angles indicating more severe forward head posture.
How to Measure the Craniovertebral Angle:
- Use software (KINOVEA) to draw a straight horizontal line passing through C7. Draw a second line connecting the C7 mark to the tragus of the ear. Measure the angle formed by these two lines (the acute angle).
- Normal value of CVA: more than 50 degree.
- Patients selected with CVA ranged between 30-50 degrees.
Measured: 12 weeks
Cobb angle
To measure the Cobb angle, identify the most tilted vertebrae at the top and bottom of a scoliosis curve on an X-ray (anteroposterior view).
Steps to Measure Cobb Angle:
- Identify End Vertebrae: Select the highest vertebra (upper end vertebra) and lowest vertebra (lower end vertebra) in the curve that are most tilted toward the concavity.
- Draw Parallel Lines:
- Draw a line parallel to the superior (top) endplate of the upper vertebra.
- Draw a line parallel to the inferior (bottom) endplate of the lower vertebra.
- Draw Perpendicular Lines: Draw a line perpendicular (90 degrees) to each of the lines drawn in step 2.
- Measure the Angle: The angle formed at the intersection of these two perpendicular lines is the Cobb angle.
A curve of more than or equal 10 degrees is defined as scoliosis.
Measured: 12 weeks
The Functional Shoulder Score (FSS)
The FSS is an 11-item patient-reported subjective outcome questionnaire consisting of two major categories - pain (one question) and activities of daily living (ADLs) (10 questions). Subjects will answer each question on a 10-point numeric rating scale, with a lower number always indicating worse pain or greater difficulty in function. The maximum score of 100 represents the total absence of pain and best possible function. The minimum score of 0 represents the worst possible result. Fifty points will be allocated for pain and 50 for ADLs. The final score will be calculated by multiplying the value indicated by the patient's answer to the question about pain by 5 and adding this to the half the sum of the total value recorded for ADLs.
Measured: 12 weeks
Secondary outcomes (1)
Functional Assessment of Cancer Therapy-Breast Quality-of- Life Instrument:
The Functional Assessment of Cancer Therapy-Breast (FACT-B) is a widely used 37-item, self-report questionnaire designed to measure the quality of life (QoL) in breast cancer patients. It covers five domains-physical, social/family, emotional, and functional well-being, plus a Breast Cancer Subscale (BCS) addressing specific issues like body image and arm tenderness. It is a 5-point Likert scale (0-4: Not at all to Very much). Scores are summed, with negatively worded items reversed, to calculate subscales (Physical, Social, Emotional, Functional, and Breast Cancer-specific) and a total score (0-148), where higher scores indicate better quality of life.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start2 Mar 2026 (estimated)
- Primary completion7 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivian Samy Ayad Hana, Cairo University
- Investigators
- George Nashed, Professor, Study director, Cairo UniversityAmal Abd El-Baky, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447024
- Sponsor's protocol ID
- P.T.REC/012/004071
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selected Exercise Program on Upper Cross Syndrome Post-unilateral Mastectomy
- ClinicalTrials.gov ID
- NCT07447024
- Acronym / sponsor ID
- P.T.REC/012/004071
- Conditions
- Mastectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 7 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 3 Mar 2026 (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.
The purpose of the study is to evaluate the therapeutic efficacy of exercise rehabilitation program on upper limb range and forward head posture post unilateral radical mastectomy.
Detailed description
Upper cross syndrome (forward head posture and rounded shoulder) is a major problem facing physical therapist, which causes an increase in pain, limitation of quality of life and delayed rehabilitation process.
The lack in knowledge and information in the published studies about effects of exercise program in forward head posture and rounded shoulder in female's management post unilateral mastectomy. This study will be carried out to investigate the effectiveness exercise program in improving the range of motion in shoulder and forward head posture in females post unilateral mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selected exercise program group | Experimental | Other: Selected exercise program, Drug: Routine medical therapyPatient will receive exercise program (stretching, strengthening and active range of motion (ROM) exercise) and routine medical treatment for 12 weeks. |
| Routine medical treatment | Active comparator | Drug: Routine medical therapyPatients will receive routine medical treatment only for 12 weeks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject selection will be according to the following criteria:
- Age range between 45-65years.
- Females only will participate in the study.
- All patients have upper cross syndrome post-unilateral modified radical mastectomy
- All patients relatives enrolled the study will have their informed consent.
Key exclusion criteria (6 listed)
- Age more than 65 years or less than45 years.
- Subjects who have hearing problems
- Patients have acute viral diseases, acute tuberculosis, mental disorders or those with pacemakers.
- Diabetic, cardiac and renal patients.
- Genetic disease
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 |
|---|---|---|
| Selected exercise programAlso: Exercise programPatients who have upper cross syndrome post unilateral modified radical mastectomy and who will receive exercise program (strengthening, active range of motion exercise, and strengthening exercises including prone scapular stabilization, shoulders shrug McKenzie exercise for neck, repeated shoulder horizontal adduction, repeated shoulder flexion, repeated shoulder extension, neck flexion McKenzie exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12weeks, time of session is 45 minutes. | Other | Selected exercise program group |
| Routine medical therapyFor pain relief: Acetaminophen: 2 pills two times per day. Ibuprofen 400 mg: 1 pill two times per day. Hormonal therapy: Tamoxifen 20 mg: once daily. Silicone gel creams (Biocorneum): 3 times per day. These medications will be given for all patients throughout the treatment period (12 weeks). | Drug | Routine medical treatment, Selected exercise program group |
Primary outcome
Craniovertebral angle (CVA)
Time frame: 12 weeks
The Craniovertebral angle (CVA) is measured by creating an angle between a horizontal line passing through the seventh cervical (C7) vertebra and a line connecting C7 to the tragus of the ear. It is commonly used to assess forward head posture, with smaller angles indicating more severe forward head posture. How to Measure the Craniovertebral Angle: • Use software (KINOVEA) to draw a straight horizontal line passing through C7. Draw a second line connecting the C7 mark to the tragus of the ear. Measure the angle formed by these two lines (the acute angle). * Normal value of CVA: more than 50 degree. * Patients selected with CVA ranged between 30-50 degrees.
Cobb angle
Time frame: 12 weeks
To measure the Cobb angle, identify the most tilted vertebrae at the top and bottom of a scoliosis curve on an X-ray (anteroposterior view). Steps to Measure Cobb Angle: 1. Identify End Vertebrae: Select the highest vertebra (upper end vertebra) and lowest vertebra (lower end vertebra) in the curve that are most tilted toward the concavity. 2. Draw Parallel Lines: * Draw a line parallel to the superior (top) endplate of the upper vertebra. * Draw a line parallel to the inferior (bottom) endplate of the lower vertebra. 3. Draw Perpendicular Lines: Draw a line perpendicular (90 degrees) to each of the lines drawn in step 2. 4. Measure the Angle: The angle formed at the intersection of these two perpendicular lines is the Cobb angle. A curve of more than or equal 10 degrees is defined as scoliosis.
The Functional Shoulder Score (FSS)
Time frame: 12 weeks
The FSS is an 11-item patient-reported subjective outcome questionnaire consisting of two major categories - pain (one question) and activities of daily living (ADLs) (10 questions). Subjects will answer each question on a 10-point numeric rating scale, with a lower number always indicating worse pain or greater difficulty in function. The maximum score of 100 represents the total absence of pain and best possible function. The minimum score of 0 represents the worst possible result. Fifty points will be allocated for pain and 50 for ADLs. The final score will be calculated by multiplying the value indicated by the patient's answer to the question about pain by 5 and adding this to the half the sum of the total value recorded for ADLs.
1 secondary outcome
Functional Assessment of Cancer Therapy-Breast Quality-of- Life Instrument:
Time frame: 12 weeks
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 3 Mar 2026.
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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.
George Nashed, Professor study director
Cairo University
Amal Abd El-Baky, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selected exercise program and Routine medical therapy in people with Mastectomy, run by Cairo University 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: opening soon, as of the sponsor's last update on 3 Mar 2026. 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 Vivian Hana, Master (01227288945, viviansamy1983@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craniovertebral angle (CVA) (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 3 Mar 2026; AzTrials last refreshed its copy on 28 Oct 2026.