The Prone Breast Radiation Therapy Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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The risk of moist desquamation in large breasted women remains unacceptably high and reactions tends to be severe and produce significant permanent and delayed side effects. Evidence suggests that the use of a prone breast IMRT technique has the potential to decrease the risk of moist desquamation in large breasted women to the levels that are now seen when average/smaller breasted women are treated with supine IMRT. As prone breast XRT is currently only offered at 6 of 15 of the Ontario Cancer Centres polled for the purposes of providing motivation for this study, a multicentre RCT is feasible to confirm and quantify the improvement provided by the prone technique and provide Level 1 evidence for it to be adopted world-wide.

Official Title
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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

Conditions
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Ductal Carcinoma In Situ, Invasive Breast Cancer

Intervention / Treatment
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* Radiation: Radiation Therapy Positioning Intervention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RT Positioning Intervention: Supine<br>Patient will be treated in a supine position as per standard of care/control. | Radiation: Radiation Therapy Positioning Intervention<br>* All participants will receive an adjuvant XRT dose to the breast of 50Gy in 25 fractions using an IMRT technique. In both arms, boost to the surgical bed using a mini-tangent technique will be delivered at the treating oncologist's discretion. Acceptable boost doses are 1600cGy/8 fractions, 1000cGy/5 fractions or 1325cGy/25 fractions as a simulatenous integrated boost. Participants randomized to the supine arm will be positioned supine on an angled breast board, with the ipsilateral arm abducted over her head. Participants randomized to the prone arm will be positioned prone on a prone breast board with both arms immobilized above the participant's head. The us of a cushion-like VaclocTM device is permitted at the treating physician's discretion. Radiation beams will be shaped to encompass the breast volume requiring treatment in both arms.<br>|
| Experimental: RT Positioning Intervention: Prone<br>Patient will be treated in the prone position. | Radiation: Radiation Therapy Positioning Intervention<br>* All participants will receive an adjuvant XRT dose to the breast of 50Gy in 25 fractions using an IMRT technique. In both arms, boost to the surgical bed using a mini-tangent technique will be delivered at the treating oncologist's discretion. Acceptable boost doses are 1600cGy/8 fractions, 1000cGy/5 fractions or 1325cGy/25 fractions as a simulatenous integrated boost. Participants randomized to the supine arm will be positioned supine on an angled breast board, with the ipsilateral arm abducted over her head. Participants randomized to the prone arm will be positioned prone on a prone breast board with both arms immobilized above the participant's head. The us of a cushion-like VaclocTM device is permitted at the treating physician's discretion. Radiation beams will be shaped to encompass the breast volume requiring treatment in both arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DCIS, Early Stage Invasive breast cancer, Prone breast radiotherapy