Breast CancerNCT06764394
The Effect of Myofascial Release Exercises on Viscoelastic Changes of the Pectoralis Major Muscle, Pain, Range of Motion and Shoulder Functionality in Individuals Receiving Adjuvant Radiotherapy After Breast Cancer Surgery
A study testing Exercise in people with Breast Cancer, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Chemotherapy, hormone therapy and radiotherapy used in the treatment of breast cancer try to prevent the recurrence of cancer. In addition to the benefits of radiotherapy, such as a decrease in recurrence and an increase in long-term survival, it may have side effects that may affect the well-being and daily life… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2024to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Stage I-II-III defined by radiation oncologists after breast cancer surgery and who will start radiotherapy
- Breast conserving surgery or total mastectomy with axillary lymph node dissection during surgery
- No neurological or orthopaedic problems that may limit the range of motion of the shoulder joint in the preoperative evaluations,
- Individuals who volunteer to participate in the study will be included.
Who cannot join
- Previous breast clamp surgery on the same side or contralateral side,
- With a metastatic cancer focus,
- Post-surgical resistance, infection and open wound, pacemaker,
- Patients with a Mini Mental State Examination test score of less than 21 will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU. Prof. Dr. Cemil Taşçıoğlu City Hospital- Oncology Clinic
Istanbul
About this study
Official title: The Effect of Myofascial Release Exercises on Viscoelastic Changes of the Pectoralis Major Muscle
Chemotherapy, hormone therapy and radiotherapy used in the treatment of breast cancer try to prevent the recurrence of cancer. In addition to the benefits of radiotherapy, such as a decrease in recurrence and an increase in long-term survival, it may have side effects that may affect the well-being and daily life activities of patients. One of the treatment modalities used to cope with treatment-related side effects is myofascial release exercises. Myofascial release exercises can help reduce adhesions caused by scar tissue and fibrosis caused by radiation. In the literature, there is no study investigating the effect of myofascial release exercises on pectoralis major muscle viscoelastic structure. For this purpose, our study aims to investigate the effect of myofascial release exercises performed in addition to home exercise programme on pectoralis major muscle viscoelastic structure, pain, range of motion and shoulder functionality.
- Conditions
- Breast Cancer
- Being tested
- Exercise
- Keywords
- myofascial release exercises, breast cancer, radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called home based exercise
home based exercise 5 days/week
ExerciseOther
home based exercise plus myofacial release exercise Myofascial release exercises will continue for 6 weeks, 2 sessions per week and each session will continue for 30 minutes.All evaluations will be performed at the beginning of radiotherapy treatment and at the end of the 6th week.
| Study group | Role | What they receive |
|---|---|---|
| home based exercise group | Active comparator | home-based exercise 5 days a week |
| Myofascial release exercise group | Experimental | home based exercise plus Myofascial release exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tone - pectoralis major
Myoton® PRO (Myoton Ltd, Myoton AS, Estonia) device will be used to objectively evaluate the measurement of Pectoralis Major muscle tone of the patients who will participate in the study. Myoton® PRO is a portable digital device that measures the tone with an objective and noninvasive method.
A constant pre-pressure (0.18 N) is applied to the skin surface to compress the subcutaneous superficial tissues. The tension state of the tissue that characterized by the natural oscillation frequency; Hz.
Measured: 6 weeks
Range of motion
Shoulder range of motion will be evaluated by digital goniometer. Shoulder flexion degree, shoulder extension degree, abduction and adduction degree, internal rotation and external rotation degree will be assessed with digital goniometer. The results will be recorded in degrees.
Measured: 6 weeks
Secondary outcomes (3)
Pain - Visual Analogue Scale
Visual Analogue Scale is one of the simple and common methods used in pain assessment. Self reported pain intensity during the rest and the activity measured by 0-10 centimeter chart. Visual Analogue Scale (VAS), where 0 indicates no pain or best and 10 indicates the most intense pain imaginable or worst. The patient will mark the severity of the pain on a 10 cm long chart
Measured: 6 weeks
Shoulder Pain and Disability Index- SPADI
Shoulder Pain and Disability Index: The Shoulder Pain and Disability Index (SPADI) is used to assess the pain and disability of individuals during certain activities. The SPADI is an assessment method consisting of two sub-headings, pain and functional status, which are completed in approximately 5-10 minutes. The first part consists of 5 questions to assess the level of pain during lying down, lying on the affected side and pushing activities. The second part consisting of 8 questions evaluates the functional status by questioning dressing, personal care and carrying activities. The subjects answer each question using a 10 cm Visual Analogue Scale. The answers to the questions are calculated as percentiles. The total score varies between 0-130, with the higher percentile indicating increased disability.
Measured: 6 weeks
Quality of Life- Functional Assessment of Cancer Therapy-Breast" (FACT-B)
It is designed to evaluate the quality of life in breast cancer patients from multiple perspectives. Its validity and reliability have been demonstrated. It consists of 5 subscales that assess quality of life as physical condition (7 questions), social life and family status (7 questions), emotional status (6 questions), activity status (7 questions), and other breast cancer-specific concerns (9 questions). The survey has 5-point likert scoring (0=not at all, 1=a little, 2=a little, 3=quite a lot, 4=a lot) . The total score is calculated by summing the subscale scores. A higher score on the questionnaire indicates a higher quality of life
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start20 Dec 2024
- Primary completion30 Mar 2025
- Study completion10 May 2025
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.
- More trials run by Acibadem 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Feyzioğlu, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764394
- Sponsor's protocol ID
- ATADEK 2024-19/733
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 25 Nov 2025
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myofascial Release Exercises on Viscoelastic Changes of the Pectoralis Major Muscle
- ClinicalTrials.gov ID
- NCT06764394
- Acronym / sponsor ID
- ATADEK 2024-19/733
- Conditions
- Breast Cancer
- Keywords
- myofascial release exercises, breast cancer, radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 8 Jan 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.
Chemotherapy, hormone therapy and radiotherapy used in the treatment of breast cancer try to prevent the recurrence of cancer. In addition to the benefits of radiotherapy, such as a decrease in recurrence and an increase in long-term survival, it may have side effects that may affect the well-being and daily life activities of patients. One of the treatment modalities used to cope with treatment-related side effects is myofascial release exercises. Myofascial release exercises can help reduce adhesions caused by scar tissue and fibrosis caused by radiation. In the literature, there is no study investigating the effect of myofascial release exercises on pectoralis major muscle viscoelastic structure. For this purpose, our study aims to investigate the effect of myofascial release exercises performed in addition to home exercise programme on pectoralis major muscle viscoelastic structure, pain, range of motion and shoulder functionality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home based exercise group | Active comparator | –home-based exercise 5 days a week |
| Myofascial release exercise group | Experimental | Other: Exercisehome based exercise plus Myofascial release exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -Stage I-II-III defined by radiation oncologists after breast cancer surgery and who will start radiotherapy
- Breast conserving surgery or total mastectomy with axillary lymph node dissection during surgery
- No neurological or orthopaedic problems that may limit the range of motion of the shoulder joint in the preoperative evaluations,
- Individuals who volunteer to participate in the study will be included.
Key exclusion criteria (4 listed)
- Previous breast clamp surgery on the same side or contralateral side,
- With a metastatic cancer focus,
- Post-surgical resistance, infection and open wound, pacemaker,
- Patients with a Mini Mental State Examination test score of less than 21 will be excluded from the study.
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 |
|---|---|---|
| ExerciseAlso: home based exercisehome based exercise 5 days/week | Other | – |
| Exercisehome based exercise plus myofacial release exercise Myofascial release exercises will continue for 6 weeks, 2 sessions per week and each session will continue for 30 minutes.All evaluations will be performed at the beginning of radiotherapy treatment and at the end of the 6th week. | Other | Myofascial release exercise group |
Primary outcome
Tone - pectoralis major
Time frame: 6 weeks
Myoton® PRO (Myoton Ltd, Myoton AS, Estonia) device will be used to objectively evaluate the measurement of Pectoralis Major muscle tone of the patients who will participate in the study. Myoton® PRO is a portable digital device that measures the tone with an objective and noninvasive method. A constant pre-pressure (0.18 N) is applied to the skin surface to compress the subcutaneous superficial tissues. The tension state of the tissue that characterized by the natural oscillation frequency; Hz.
Range of motion
Time frame: 6 weeks
Shoulder range of motion will be evaluated by digital goniometer. Shoulder flexion degree, shoulder extension degree, abduction and adduction degree, internal rotation and external rotation degree will be assessed with digital goniometer. The results will be recorded in degrees.
3 secondary outcomes
Pain - Visual Analogue Scale
Time frame: 6 weeks
Shoulder Pain and Disability Index- SPADI
Time frame: 6 weeks
Quality of Life- Functional Assessment of Cancer Therapy-Breast" (FACT-B)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Breast Cancer, run by Acibadem University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 25 Nov 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tone - pectoralis major (time frame: 6 weeks). The study lists 2 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 25 Nov 2025.