The Prone Breast Radiation Therapy Trial

September 9, 2019 updated by: Danny Vesprini, MD, MSc, FRCPC, Toronto Sunnybrook Regional Cancer Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

378

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R6V5
        • British Columbia Cancer Agency - Vancouver Island Centre
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: RT Positioning Intervention: Supine
Patient will be treated in a supine position as per standard of care/control.
Radiation: Radiation Therapy Positioning Intervention
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.
Experimental: RT Positioning Intervention: Prone
Patient will be treated in the prone position.
Radiation: Radiation Therapy Positioning Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-8 week post-treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-8 week post-treatment.
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.
Day 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toronto Sunnybrook Regional Cancer Centre

Collaborators

Canadian Breast Cancer Foundation

Investigators

  • Principal Investigator: Danny Vesprini, MD MSc FRCPC, Toronto Sunnybrook Regional Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2013

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

March 15, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 380-2012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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