The purpose of this study is to investigate the difference in fatigue, quality of life and radiation morbidity between hypofractionated and conventional radiation to the breast, chest wall and regional lymph nodes post mastectomy or lumpectomy
Breast cancer is the most commonly diagnosed cancer in Australia. Radiotherapy to the breast, chest wall and regional lymph nodes for breast cancer after surgery can reduce the risk of local recurrence by 50% and reduce breast cancer mortality. Traditionally, radiotherapy is delivered in a large number of small doses i.e. 25 treatment sessions over 5 1/2 weeks. Another approach is to give a lower number of larger doses i.e. 15 sessions over 3 1/2 weeks (hypofractionated radiotherapy). Several studies in Europe and Asia have investigated hypofractionated radiotherapy to the chest wall, breast and regional lymph nodes following surgery for breast cancer, and found that it is equally effective to standard treatment, with similar side effects. These two approaches have not been directly compared in Australia. This trial is to compare these two approaches, to determine whether hypofractionated radiotherapy is better tolerated by patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
The purpose of this study is to investigate toxicity following standard conventional fractionation versus moderately hypofractionated radiotherapy to the breast, chest wall and regional lymph nodes
Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital
St Leonards, New South Wales, Australia
Fatigue
Changes in patient reported fatigue at six weeks post commencing radiotherapy compared to baseline fatigue score. Fatigue score is rated as fatigue that interfered with patients' normal daily activities from "all of the time", "most of the time", "a good bit of the time", "some of the time", "a little of the time", "hardly any of the time", "none of the time" with the "all of the time" being the worst outcome
Time frame: six weeks post radiation treatment
Changes in patients' quality of life
Changes in patients' quality of life during radiotherapy and follow up period are captured by questionnaires. The questions are for examples how difficult is it in planning or being able to continue your usual activities?, how often have you felt low in energy? The score scales are from "all of the time", "most of the time", "a good bit of the time", "some of the time", "a little of the time", "hardly any of the time", "none of the time" with the "all of the time" being the worst outcome
Time frame: first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
Number of participants with acute radiation dermatitis in irradiated area
Grade 2 or worse radiation dermatitis
Time frame: During treatment
Number of participants with ipsilateral arm lymphoedema
The circumference of the ipsilateral arm \>=10% increased compared to the other arm defines oedema
Time frame: 3 years post radiation treatment
Number of participants with ipsilateral arm range of motion
Impaired shoulder movement is present when \>20 degrees difference between arms at flexion and/or abduction
Time frame: 3 years post radiation treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Disease Recurrence
Any disease progression or recurrence - location and time of event
Time frame: 5 years from treatment
Self reported acute & late radiation toxicities
acute radiation toxicities during treatment and late radiation toxicities are captured by questionnaires
Time frame: first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years
Compare the indirect radiation therapy costs by 2 treatment arms
data of cost of attending treatment, work and lifestyle impact are captured by questionnaires
Time frame: 4 weeks post radiation treatment