Invasive Breast Cancer Clinical Trial
Official title:
A Multicentre Randomized Controlled Clinical Trial for the Reduction of Acute Skin Reaction in Adjuvant Breast Radiation in Large Breasted Women Using a Prone Technique - The Prone Breast Trial
NCT number | NCT01815476 |
Other study ID # | 380-2012 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 4, 2013 |
Est. completion date | June 2019 |
Verified date | September 2019 |
Source | Toronto Sunnybrook Regional Cancer Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Participants undergoing radiation after breast conserving surgery for an early breast cancer
(either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at
increased risk of developing a skin reaction because of their large breast size.
After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or
early stage invasive breast cancer receive radiation to the breast to decrease the risk of
cancer recurrence. Breast radiation is usually done with women lying on their back
("supine"). Some women develop temporary breakdown of the skin (moist desquamation). This
skin reaction can be painful and has been linked to long term side effects such as chronic
pain and decreased quality of life.
This study is being done because women with large breasts have higher rates of skin breakdown
(called 'moist desquamation') and breast pain during and shortly after radiation therapy is
complete. It is unclear if such skin reactions and pain would be improved by alternating
treatment position - namely lying on your belly ("prone") during their radiation treatment.
Status | Completed |
Enrollment | 378 |
Est. completion date | June 2019 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (DCIS); - treated with BCT; - no indication for treatment of regional LN; - Women with a bra size of 40 inches or greater, or a pre-surgery cup size of D or greater Exclusion Criteria: - Regional Lymph Node XRT indicated; - Bilateral breast cancer; - unhealed wound (skin not closed and/or infection); - previous XRT to the same breast; - unable to lie prone; - presence of active connective tissue disease; - pregnancy; - unacceptable heart exposure (as measured by > 10% of the heart receiving 50% of the prescribed dose, i.e. V25Gy > 10%); - adequate coverage of postoperative tumour bed not technically possible |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Odette Cancer Centre | Toronto | Ontario |
Canada | British Columbia Cancer Agency - Vancouver Island centre | Victoria | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Toronto Sunnybrook Regional Cancer Centre | Canadian Breast Cancer Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient Reported Quality of life | Change in health related Quality of Life as per the EORTC core QoL questionnaire QLQ-C30 and the breast cancer module QLQ-BR23. | Questionnaires will be completed by subjects at time of radiation simulation as baseline, in the 5th week of radiation therapy treatment (during routine review) and at 6-8 week follow-up. | |
Primary | Moist Desquamation | Acute moist desquamation rates as measured by CTCAE 4.03 during and up to 6-8 weeks post treatment. | 6-8 week post-treatment. | |
Secondary | Breast Pain | Acute breast pain rates as measured by CTCAE 4.03 and Visual Analog Scale (VAS) during and up to 6-8 weeks post treatment. | 6-8 week post-treatment. | |
Secondary | Radiation exposure of adjacent normal organs at risk | Determine if adjuvant breast IMRT in the prone position produces improved dose distribution in regards to exposure to critical structures including heart, lung, liver and contralateral breast when compared to treatment in the supine position. | Day 1 |
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