Skip to main content
OpenTrials
Completed

NCT Number: NCT01815476

The Prone Breast Radiation Therapy Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ductal Carcinoma in Situ Adenocarcinoma Breast Carcinoma In Situ Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Invasive Breast Cancer Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Cancer Agency - Vancouver Island centre, Victoria, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation Therapy Positioning Intervention

Radiation

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.

Primary outcomes

  1. Moist Desquamation

    Time frame: 6-8 week post-treatment.

    Acute moist desquamation rates as measured by CTCAE 4.03 during and up to 6-8 weeks post treatment.

Secondary outcomes

  1. Breast Pain

    Time frame: 6-8 week post-treatment.

    Acute breast pain rates as measured by CTCAE 4.03 and Visual Analog Scale (VAS) during and up to 6-8 weeks post treatment.

  2. Radiation exposure of adjacent normal organs at risk

    Time frame: Day 1

    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.

Other outcomes

  1. Patient Reported Quality of life

    Time frame: 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.

    Change in health related Quality of Life as per the EORTC core QoL questionnaire QLQ-C30 and the breast cancer module QLQ-BR23.

Sponsors and collaborators

Lead sponsor

Toronto Sunnybrook Regional Cancer Centre

Other

Collaborators

  • Canadian Breast Cancer Foundation

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Mar 21, 2013
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.