Breast Cancer, Post Mastectomy
Conditions
Keywords
radiotherapy, hypofractionation, quality of life
Brief summary
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
Detailed description
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.
Interventions
RADIATIONHypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy
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
Sponsors
Royal North Shore Hospital
Northern Sydney and Central Coast Area Health Service
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients will be randomised to one of the arms and will be notified for the randomization results. Randomisation ratio 2:1 (hypofractionation : standard)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * ECOG performance status 0-2 * Ability to understand and willingness to sign a written informed consent document * Stage pT1-3, pN0-3, M0 histologically proven breast cancer no matter the status of ER/PR/HER2 receptor testing * Managed with either mastectomy or breast conserving surgery * Suitable for radiation therapy to the breast/chest wall and regional lymph nodes * Neoadjuvant and adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 therapy is accepted * Neoadjuvant radiotherapy (reverse sequencing) accepted * Breast implants and expanders are accepted * Patients with connective tissue disease are allowed if the treating radiation oncologist finds radiation therapy indicated * Life expectancy minimum 10 years * Patients with non-breast malignancies are accepted if the patient has been disease free for five years and/or has a low risk of recurrence as estimated by the treating radiation oncologist (to be determined at initial patient appointment)
Exclusion criteria
* Prior radiotherapy to the ipsilateral breast or chest wall * Pregnancy or lactation * Radiosensitivity syndrome * Permanent pacemaker/defibrillator within radiotherapy field * Oncoplastic surgery where boost volume unacceptable (clinician discretion) * Conditions indicating that the patient cannot go through radiation therapy or follow up, or a condition where the treating oncologist thinks the patient should not participate in the trial (for example, language barriers)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | six weeks post radiation treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in patients' quality of life | first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years | 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 |
| Number of participants with acute radiation dermatitis in irradiated area | During treatment | Grade 2 or worse radiation dermatitis |
| Number of participants with ipsilateral arm lymphoedema | 3 years post radiation treatment | The circumference of the ipsilateral arm \>=10% increased compared to the other arm defines oedema |
| Number of participants with ipsilateral arm range of motion | 3 years post radiation treatment | Impaired shoulder movement is present when \>20 degrees difference between arms at flexion and/or abduction |
| Disease Recurrence | 5 years from treatment | Any disease progression or recurrence - location and time of event |
| Self reported acute & late radiation toxicities | first to 8th weeks post radiation treatment, half yearly for 2 years, annually for 3 years | acute radiation toxicities during treatment and late radiation toxicities are captured by questionnaires |
| Compare the indirect radiation therapy costs by 2 treatment arms | 4 weeks post radiation treatment | data of cost of attending treatment, work and lifestyle impact are captured by questionnaires |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORSusan Carroll, MBBS FRANZCR
Radiation Oncology Department, Royal North Shore Hospital
Outcome results
None listed