Breast CancerNCT04507789
Exercise Therapy During Radiotherapy
A study testing exercise intervention and routine radiotherapy protokol in people with Breast Cancer and Exercise Therapy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The main purpose of our study is to investigate the effects of exercise therapy on upper extremity functions in patients receiving radiotherapy to the axillary region after breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Exercise Therapy, Radiotherapy
- What is being tested?
- exercise intervention and routine radiotherapy protokol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2020to 10 Apr 2021
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients İn the age range of 18-65
- Receiving radiotherapy to the axillary region after surgery with breast cancer diagnosis
Who cannot join
- Radiotherapy area to contain only the chest wall
- Any orthopedic injury or trauma involving the upper extremity prior to or during the cancer diagnosis
- The presence of metastases in any area other than breast tissue
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Abdurrahman Yurtaslan Onkoloji Hospital
Ankara, Yenimahalle, 06200
Damlagül Aydin Özcan, 0530 873 99 63, damlagulozcan@gmail.com
About this study
Official title: Investigation of the Effectiveness of Exercise Training During Radiotherapy in Postoperative Breast Cancer
The main purpose of our study is to investigate the effects of exercise therapy on upper extremity functions in patients receiving radiotherapy to the axillary region after breast cancer surgery.
Read the detailed description
Our study will take in place in radiation oncology clinic. In routine the patients which will receive axillary area radiotherapy will randomized into 2 groups will explained in study arms section later. There are papers explained about radiotherapy side effects to upper extremity functions. But there is lack of evidence about exercise therapy during radiotherapy protocol to cope with its side effects to upper extremity functions. In this study we will compare two groups upper extremity function related outcomes at the end of the radiotherapy sessions and also before and after results for two groups.
- Conditions
- Breast Cancer, Exercise Therapy, Radiotherapy, Upper Extremity Problem
- Being tested
- exercise intervention, routine radiotherapy protokol
- Keywords
- Breast cancer, Exercise therapy, 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.
exercise interventionOther
Exercise protocol will consist of the recommended special exercise sets for upper extremity problems on mastectomy patients. The upper extremity protocol has published in 2018 by Richmond and friends called prevention of musculoskeletal shoulder problems after breast cancer treatment UK-PROSPER protocol.this special protocol has unique exercise sets for to restore shoulder range of motion, to maintain good force level of upper extremity muscles and stretch exercises especially to the muscles around the radiotherapy area. Exercises will be done under the supervision of a specialized physiotherapist about upper extremity disorders.
routine radiotherapy protokolOther
This intervention is only an observation to patients during their routine radiotherapy protocol. There will be no exercise intervention for the upper extremity for the patient in this group.
| Study group | Role | What they receive |
|---|---|---|
| exercise intervention group | Experimental | This group will be taken an exercise intervention during their radiotherapy programme. Receives: Other: exercise intervention |
| routine radiotherapy protocol | Active comparator | This group will not be taken into an exercise intervention during their radiotherapy programme. Receives: Other: routine radiotherapy protokol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity functional status of patients during radiotherapy protocol
The subjective upper extremity functional status will assessed by The Disabilities of the Arm, Shoulder and Hand Score (DASH). This is 30 questions Questionnaire and 21 evaluate the person's difficulties during daily activities, 5 of them (pain, stiffness, tingling, weakness) and 4 of them evaluate work, sleep, social function and self-confidence. The person answers all questions according to the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). A score of 0-100 is obtained from each section. As the score increases, the disability increases.
Measured: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Shoulder joint range of motion (ROM) of patients during radiotherapy protocol
Shoulder range of motion in flexion, abduction, internal rotation and external rotation will be evaluated by the standard goniometer. Total Active and passive degree of ROM will be evaluated in patient sitting position. Total ROM will record in degree value.
Measured: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Hand Grip force measurement of patients during radiotherapy protocol
Jamar hand dynamometer will be used for to evaluate gross hand grip force. While the patient is sitting with a back support in a comfortable seat, he will be asked to grasp the dynamometer with a gross grip at 90˚ flexion and compress it as strong as she can. 3 measurements will be made for both hands and the average of the values in kg will be recorded.
Measured: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Secondary outcomes (8)
Fear of movement, avoidance reaction of patients during radiotherapy protocol
Tampa kinesiophobia ( fear of pain due to movement) scale will be used to evaluate the fear of movement degree. The survey has 17 question as a scale that is answered according to the 4-point Likert system. Total point will be between 17-68. As the score increases, the fear of movement increases.
Measured: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Physical activity level of patients during radiotherapy protocol
It will be evaluated by a short version of the International Physical Activity survey. The questionnaire consists of 7 questions and has open-ended questions for the physical activities to be filled in by the patient for the duration of activity and number of days.
Measured: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Pain and sensory impairment of patients during radiotherapy protocol
The McGill Pain short form scale will be used to evaluate patients sensory impairment. In the scale, 2 scores will be counted, first one is the total number of words defined by the person related to pain and sensation. Second score will be given by the patient to herself on visual analog scale in the range of 0-10. 10 means the worst pain while 0 is no pain.
Measured: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Scapular dyskinesia of patients during radiotherapy protocol
Lateral Slide Test method will be used to measure the scapular dyskinesia. In this method; While the patient is in a standing position the bottom corner of the scapula will be marked and the perpendicular length to the nearest vertebra will be measured with the help of tape for both scapulae. Then the same measurement will be repeated while the hands are at the waist and the hands are held in the 90˚ abduction position. The difference in scapula movement for both sides will be noted in cm.
Measured: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Upper extremity kinesthesia and shoulder joint position sensation of patients during radiotherapy protocol
While the patient's eyes closed and sitting on a chair, therapist's will be brought the shoulder range of motion to 90 degrees from the 0 degree start position. Meanwhile, angular value checks will be performed with an inclinometer fixed with velcro to mid-humeral area. A few seconds after the position is felt, the arm will be returned to the 0 degree start position. The patient will be asked to open his eyes and then he will be asked to actively bring his shoulder to the angle closest to the previous angle. Measurements will be made in 3 repetitions separately for the right and left sides and the degree differences will be determined for the sense of position and the average of the results will be taken.
Measured: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Lymph edema evaluation of patients during radiotherapy protocol
The lymph edema measurement will be made with a tape. The circumferential length around the arm will be made in every 5 cm from the distal tubercle to the shoulder. Studies have explained that a difference of up to 2 cm between both extremities can be considered normal and moderate and excessive lymph edema classification according to the difference in measurement. According to this staging, the severity of lymph edema in patients will be determined and recorded.
Measured: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Life quality of patients during radiotherapy protocol
It will be evaluated by EORTC QLQ-C30 (Cancer-specific quality of life index) . the questionnaire consists of 23 questions.The person answers all the questions according to the 4-point Likert system (1: none, 2: a little, 3: quite, 4: much). All sub scale points range between 0-100.
Measured: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Breast cancer specific life quality of patients during radiotherapy protocol
It will be evaluated by EORTC QLQ-BR23 (Breast cancer-specific quality of life index). The questionnaire consists of 30 questions The person answers all the questions according to the 4-point Likert system (1: none, 2: a little, 3: quite, 4: much).All sub scale points range between 0-100.
Measured: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start10 Oct 2020
- Primary completion10 Mar 2021 (estimated)
- Study completion10 Apr 2021 (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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Responsible party
- Principal investigator, Damlagül AYDIN ÖZCAN, Hacettepe University
- Investigators
- YAVUZ YAKUT, Study chair, ProfessorGüçlü Sezai Kılıçoğlu, Study chair, assistant doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507789
- Sponsor's protocol ID
- 2020-01
- Status last verified
- Feb 2021
- First submitted
- 4 Aug 2020
- Last updated
- 10 Feb 2021
- 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 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Exercise Training During Radiotherapy in Postoperative Breast Cancer
- ClinicalTrials.gov ID
- NCT04507789
- Acronym / sponsor ID
- 2020-01
- Conditions
- Breast Cancer, Exercise Therapy, Radiotherapy, Upper Extremity Problem
- Keywords
- Breast cancer, Exercise therapy, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 10 Mar 2021 (estimated)
- Study completion
- 10 Apr 2021 (estimated)
- First posted
- 11 Aug 2020 (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 main purpose of our study is to investigate the effects of exercise therapy on upper extremity functions in patients receiving radiotherapy to the axillary region after breast cancer surgery.
Detailed description
Our study will take in place in radiation oncology clinic. In routine the patients which will receive axillary area radiotherapy will randomized into 2 groups will explained in study arms section later. There are papers explained about radiotherapy side effects to upper extremity functions. But there is lack of evidence about exercise therapy during radiotherapy protocol to cope with its side effects to upper extremity functions. In this study we will compare two groups upper extremity function related outcomes at the end of the radiotherapy sessions and also before and after results for two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise intervention group | Experimental | Other: exercise interventionThis group will be taken an exercise intervention during their radiotherapy programme. |
| routine radiotherapy protocol | Active comparator | Other: routine radiotherapy protokolThis group will not be taken into an exercise intervention during their radiotherapy programme. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients İn the age range of 18-65
- Receiving radiotherapy to the axillary region after surgery with breast cancer diagnosis
Key exclusion criteria (3 listed)
- Radiotherapy area to contain only the chest wall
- Any orthopedic injury or trauma involving the upper extremity prior to or during the cancer diagnosis
- The presence of metastases in any area other than breast tissue
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 |
|---|---|---|
| exercise interventionExercise protocol will consist of the recommended special exercise sets for upper extremity problems on mastectomy patients. The upper extremity protocol has published in 2018 by Richmond and friends called prevention of musculoskeletal shoulder problems after breast cancer treatment UK-PROSPER protocol.this special protocol has unique exercise sets for to restore shoulder range of motion, to maintain good force level of upper extremity muscles and stretch exercises especially to the muscles around the radiotherapy area. Exercises will be done under the supervision of a specialized physiotherapist about upper extremity disorders. | Other | exercise intervention group |
| routine radiotherapy protokolThis intervention is only an observation to patients during their routine radiotherapy protocol. There will be no exercise intervention for the upper extremity for the patient in this group. | Other | routine radiotherapy protocol |
Primary outcome
Upper extremity functional status of patients during radiotherapy protocol
Time frame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
The subjective upper extremity functional status will assessed by The Disabilities of the Arm, Shoulder and Hand Score (DASH). This is 30 questions Questionnaire and 21 evaluate the person's difficulties during daily activities, 5 of them (pain, stiffness, tingling, weakness) and 4 of them evaluate work, sleep, social function and self-confidence. The person answers all questions according to the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). A score of 0-100 is obtained from each section. As the score increases, the disability increases.
Shoulder joint range of motion (ROM) of patients during radiotherapy protocol
Time frame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Shoulder range of motion in flexion, abduction, internal rotation and external rotation will be evaluated by the standard goniometer. Total Active and passive degree of ROM will be evaluated in patient sitting position. Total ROM will record in degree value.
Hand Grip force measurement of patients during radiotherapy protocol
Time frame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Jamar hand dynamometer will be used for to evaluate gross hand grip force. While the patient is sitting with a back support in a comfortable seat, he will be asked to grasp the dynamometer with a gross grip at 90˚ flexion and compress it as strong as she can. 3 measurements will be made for both hands and the average of the values in kg will be recorded.
8 secondary outcomes
Fear of movement, avoidance reaction of patients during radiotherapy protocol
Time frame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Physical activity level of patients during radiotherapy protocol
Time frame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Pain and sensory impairment of patients during radiotherapy protocol
Time frame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Scapular dyskinesia of patients during radiotherapy protocol
Time frame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Upper extremity kinesthesia and shoulder joint position sensation of patients during radiotherapy protocol
Time frame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Lymph edema evaluation of patients during radiotherapy protocol
Time frame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Life quality of patients during radiotherapy protocol
Time frame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Breast cancer specific life quality of patients during radiotherapy protocol
Time frame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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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.
YAVUZ YAKUT study chair
Professor
Güçlü Sezai Kılıçoğlu study chair
assistant doctor
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 intervention and routine radiotherapy protokol in people with Breast Cancer and Exercise Therapy, run by Hacettepe 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DAMLAGÜL AYDİN ÖZCAN (+90 0312 3052525, damlagulozcan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity functional status of patients during radiotherapy protocol (time frame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''). 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 10 Feb 2021.