The Prone Breast Radiation Therapy Trial

Само регистрираните корисници можат да преведуваат статии

Пријавете се / пријавете се

Врската е зачувана во таблата со исечоци

СтатусЗавршено

Спонзори

Toronto Sunnybrook Regional Cancer Centre

Соработници

Canadian Breast Cancer Foundation

КЛИНИЧКО ИСПИТУВАЊЕ: NCT01815476

BioSeek: nct01815476

Клучни зборови

Апстракт

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.

Опис

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.

Датуми

Последен пат проверено:	08/31/2019
Прво доставено:	03/14/2013
Поднесено е проценето запишување:	03/18/2013
Прво објавено:	03/20/2013
Последното ажурирање е доставено:	09/08/2019
Последно ажурирање објавено:	09/10/2019
Крај на датумот на започнување на студијата:	05/03/2013
Проценет датум на примарно завршување:	03/31/2018
Проценет датум на завршување на студијата:	05/31/2019

Состојба или болест

Ductal Carcinoma In Situ

Invasive Breast Cancer

Интервенција / третман

Radiation: Radiation Therapy Positioning Intervention

Фаза

Групи за раце

Рака	Интервенција / третман
Other: RT Positioning Intervention: Supine Patient will be treated in a supine position as per standard of care/control.
Experimental: RT Positioning Intervention: Prone Patient will be treated in the prone position.

Критериуми за подобност

Полови квалификувани за студии

Female

Прифаќа здрави волонтери

Да

Критериуми

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

Исход

Мерки на примарниот исход

1. Moist Desquamation [6-8 week post-treatment.]

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

Секундарни мерки на исходот

1. Breast Pain [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 [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.

Други мерки на исход

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.]

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