Deep-inspirational breath hold during breast radiotherapy
| ISRCTN | ISRCTN14360721 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14360721 |
| Secondary identifying numbers | #272/2017 |
- Submission date
- 09/02/2021
- Registration date
- 12/02/2021
- Last edited
- 30/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Radiotherapy plays an essential role in the management of breast cancer. After undergoing breast-conserving surgery most patients need postoperative whole-breast or partial breast irradiation. Most breast cancer patients become long-term survivors, so treatments should not endanger the patients’ general health and well-being. The main radiation-related hazards are radiogenic heart and lung damage resulting in significant illness many years or decades after the radiotherapy. The risk of radiogenic heart damage is dose-dependent, but no lower threshold with the absence of risk has been identified. Hence all efforts should be made to avoid or lessen heart radiation exposure as much as possible. There are many approaches to protect the heart from radiation exposure. The breath-holding technique first used in breast cancer in 2001 only recently became widespread. Its greatest impact is a reduced radiation dose to the heart and to a lesser extent to the lung. Nevertheless, the benefit varies according to the patient’s anatomy and lung capacity, and on occasion the absence of advantage or even elevated heart doses have been described. The aim of this study is to assess the usefulness of the Deep-Inspirational Breath-Hold (DIBH) technique in left breast cancer radiotherapy.
Who could participate?
Patients aged over 18 with left-sided breast cancer who need postoperative radiotherapy
What does the study involve?
Usual radiotherapy is delivered for all patients, with the DIBH technique used if it is feasible. All the patients go through planning CT examinations in the supine position (lying on their back) while both free-breathing and DIBH, and those who need whole breast radiotherapy receive CT also in the prone position (lying on their front).
What were the possible risks and benefits?
The only risk is the extra radiation dose from the extra CT scans. The possible benefits are reduced radiation dose to the risk organs if the DIBH technique is used (most patients), and the detailed and careful dose analyses carried out. Extra attention is paid to all participants as is usual in all clinical studies.
Where is the study run from and how long is it expected to run for?
July 2017 to December 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Zsuzsanna Kahán
kahan.zsuzsanna@med.u-szeged.hu
Contact information
Scientific
Korányi fasor 12.
Szeged
6720
Hungary
| Phone | +36 (0)70 3311585 |
|---|---|
| kahan.zsuzsanna@med.u-szeged.hu |
Public
12 Korányi fasor
Szeged
6720
Hungary
| Phone | +36 (0)70 3311585 |
|---|---|
| kahan.zsuzsanna@med.u-szeged.hu |
Study information
| Study design | Prospective interventional single-arm cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Deep-Inspirational Breath-Hold (DIBH) technique in Left-sided Breast Cancer: individual decision-making is needed on its use |
| Study acronym | DIBH-LBC |
| Study hypothesis | The DIBH technique is appropriate to reduce heart doses in most cases, however, not all patients are appropriate for the technique, and not all benefit from it even if appropriate. |
| Ethics approval(s) | Approved 26/02/2018, Institutional Ethics Review Board of the University of Szeged (Regional Human Biomedical Research Ethics Committee, 6720 Szeged, Dugonics tér 13, Hungary; +36 (0)62 545997; office.rkeb@med.u-szeged.hu), ref: 272/2017 |
| Condition | Left breast cancer needing adjuvant radiotherapy |
| Intervention | Conventional radiotherapy is used with the DIBH technique, and doses to the normal tissues, risk organs are analyzed in comparison to that if DIBH is not practised (free-breathing supine or if the patient is positioned prone). The radiotherapy is given in 25 fractions, five fractions per week. Dosimetry data are analyzed in radiotherapy plans generated under DIBH, free-breathing in the supine position, and in the prone position for individual patients. All three techniques are widely used in practice. |
| Intervention type | Other |
| Primary outcome measure | Heart and LAD doses measured using dosimetry data extracted from radiotherapy plans at the time of treatment planning, before the start of the individuals' radiotherapy, and analyzed both individually before the radiotherapy and later on as a database after the last patient's radiotherapy. Dosimetry data analyzed individually whether the target dose constraints were achieved or not, and as a database using statistical methods (repeated ANOVA test and paired t-test). |
| Secondary outcome measures | Lung, breast/chest wall and lymph node doses measured using dosimetry data extracted from radiotherapy plans at the time of treatment planning, before the start of the individuals' radiotherapy, and analyzed both individually before the radiotherapy and later on as a database after the last patient's radiotherapy. Dosimetry data were analyzed individually whether the target dose constraints were achieved or not, and as a database using statistical methods (repeated ANOVA test and paired t-test). |
| Overall study start date | 01/07/2017 |
| Overall study end date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 130 |
| Participant inclusion criteria | 1. Patients >18 years old who have left-sided breast cancer 2. Eligible for postoperative radiotherapy 3. No comorbidity that could prevent practising DIBH (bronchial asthma, obesity, hypacusis etc) |
| Participant exclusion criteria | Presence of COPD, bronchial asthma or another severe comorbidity that would hinder cooperation during DIBH (extreme obesity, mental disorder, hypacusis) |
| Recruitment start date | 23/01/2018 |
| Recruitment end date | 13/11/2019 |
Locations
Countries of recruitment
- Hungary
Study participating centre
Szeged
6720
Hungary
Sponsor information
Hospital/treatment centre
Dept. Oncotherapy
Korányi fasor 12.
Szeged
6720
Hungary
| Phone | +36 (0)62 545404 |
|---|---|
| office.onko@med.u-szeged.hu | |
| Website | https://u-szeged.hu/ |
"ROR" |
https://ror.org/01pnej532 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed radiation oncology journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Zsuzsanna Kahán (kahan.zsuzsanna@med.u-szeged.hu) and Zoltán Varga (varga.zoltan@med.u-szeged.hu). The information may be provided upon request from now up to 2 years to professional teams or societies. Various dosimetry data have been collected and analyzed by statistical methods according to patient- and radiotherapy-related aspects. The patients agreed to use or share their data after anonymisation without restrictions or comments. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 01/03/2021 | No | No | ||
| Protocol file | 01/03/2021 | No | No | ||
| Results article | 13/05/2021 | 13/08/2021 | Yes | No | |
| Other files | Supplementary information, questionnaire regarding the comfort of the RT procedure | 13/05/2021 | 30/03/2023 | No | No |
Additional files
- ISRCTN14360721_PROTOCOL.pdf
- Uploaded 01/03/2021
- ISRCTN14360721_PROTOCOL_appendix1.pdf
- Uploaded 01/03/2021
- ISRCTN14360721.pdf
- Supplementary information, questionnaire regarding the comfort of the RT procedure
Editorial Notes
30/03/2023: Supplementary information added as an additional file.
13/08/2021: Internal review.
17/05/2021: Publication reference added.
01/03/2021: Uploaded protocol and protocol appendix (not peer reviewed).
12/02/2021: Trial's existence confirmed by the Institutional Ethics Review Board of the University of Szeged.
