The Prone Breast Radiation Therapy Trial
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
1 other identifier
interventional
378
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2013
CompletedFirst Posted
Study publicly available on registry
March 21, 2013
CompletedStudy Start
First participant enrolled
May 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedSeptember 11, 2019
September 1, 2019
4.9 years
March 15, 2013
September 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Breast Pain
6-8 week post-treatment.
Radiation exposure of adjacent normal organs at risk
Day 1
Other Outcomes (1)
Patient Reported Quality of life
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.
Study Arms (2)
RT Positioning Intervention: Supine
OTHERPatient will be treated in a supine position as per standard of care/control.
RT Positioning Intervention: Prone
EXPERIMENTALPatient will be treated in the prone position.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
British Columbia Cancer Agency - Vancouver Island centre
Victoria, British Columbia, V8R6V5, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Related Publications (1)
Vesprini D, Davidson M, Bosnic S, Truong P, Vallieres I, Fenkell L, Comsa D, El-Mallah M, Garcia L, Stevens C, Nakonechny K, Tran W, Kiss A, Rakovitch E, Pignol JP. Effect of Supine vs Prone Breast Radiotherapy on Acute Toxic Effects of the Skin Among Women With Large Breast Size: A Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):994-1000. doi: 10.1001/jamaoncol.2022.1479.
PMID: 35616948DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danny Vesprini, MD MSc FRCPC
Toronto Sunnybrook Regional Cancer Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Radiation Oncologist
Study Record Dates
First Submitted
March 15, 2013
First Posted
March 21, 2013
Study Start
May 4, 2013
Primary Completion
April 1, 2018
Study Completion
June 1, 2019
Last Updated
September 11, 2019
Record last verified: 2019-09