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The Prone Breast Radiation Therapy Trial

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ClinicalTrials.gov Identifier: NCT01815476
Recruitment Status : Recruiting
First Posted : March 21, 2013
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Danny Vesprini, MD, MSc, FRCPC, Toronto Sunnybrook Regional Cancer Centre

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.


Condition or disease Intervention/treatment Phase
Ductal Carcinoma In Situ Invasive Breast Cancer Radiation: Radiation Therapy Positioning Intervention Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 4, 2013
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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. 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.

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815476


Contacts
Contact: Danny Vesprini, MD MSc FRCPC 416-480 4806 Danny.Vesprini@sunnybrook.ca
Contact: Pauline Truong, MD MSc FRCPC 250 519 5500 ptruong@bccancer.bc.ca

Locations
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Island centre Not yet recruiting
Victoria, British Columbia, Canada, V8R6V5
Contact: Michael Miller, R.N    2505195741    mmiller2@bccancer.bc.ca   
Canada, Ontario
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Jeffrey Pham    416-480-5000 ext 1055    jeff.pham@sunnybrook.ca   
Principal Investigator: Danny Vesprini, MD MSc FRCPC         
Sponsors and Collaborators
Toronto Sunnybrook Regional Cancer Centre
Canadian Breast Cancer Foundation
Investigators
Principal Investigator: Danny Vesprini, MD MSc FRCPC Toronto Sunnybrook Regional Cancer Centre

Responsible Party: Danny Vesprini, MD, MSc, FRCPC, Radiation Oncologist, Toronto Sunnybrook Regional Cancer Centre
ClinicalTrials.gov Identifier: NCT01815476     History of Changes
Other Study ID Numbers: 380-2012
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Danny Vesprini, MD, MSc, FRCPC, Toronto Sunnybrook Regional Cancer Centre:
DCIS
Early Stage Invasive breast cancer
Prone breast radiotherapy

Additional relevant MeSH terms:
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ