Clinical trial NCT04507789: Exercise Therapy During Radiotherapy
Official title: Investigation of the Effectiveness of Exercise Training During Radiotherapy in Postoperative Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Exercise Therapy
Radiotherapy
Upper Extremity Problem
Keywords: Breast cancer
Exercise therapy
Radiotherapy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
First posted: 2020-08-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients İn the age range of 18-65
* Receiving radiotherapy to the axillary region after surgery with breast cancer diagnosis

Exclusion Criteria:

* 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

Primary outcomes:
measure: Upper extremity functional status of patients during radiotherapy protocol
timeFrame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
measure: Shoulder joint range of motion (ROM) of patients during radiotherapy protocol
timeFrame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
measure: Hand Grip force measurement of patients during radiotherapy protocol
timeFrame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Secondary outcomes:
measure: Fear of movement, avoidance reaction of patients during radiotherapy protocol
timeFrame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
measure: Physical activity level of patients during radiotherapy protocol
timeFrame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
measure: Pain and sensory impairment of patients during radiotherapy protocol
timeFrame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
measure: Scapular dyskinesia of patients during radiotherapy protocol
timeFrame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
measure: Upper extremity kinesthesia and shoulder joint position sensation of patients during radiotherapy protocol
timeFrame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
measure: Lymph edema evaluation of patients during radiotherapy protocol
timeFrame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
measure: Life quality of patients during radiotherapy protocol
timeFrame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
measure: Breast cancer specific life quality of patients during radiotherapy protocol
timeFrame: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Onkoloji Hospital
state: Yenimahalle
Study officials:
affiliation: Professor
name: YAVUZ YAKUT
role: STUDY_CHAIR
affiliation: assistant doctor
name: Güçlü Sezai Kılıçoğlu
role: STUDY_CHAIR
References: