The HeartSpare Study

ISRCTN	ISRCTN53585935
DOI	https://doi.org/10.1186/ISRCTN53585935
Secondary identifying numbers	11499

Submission date: 06/02/2012
Registration date: 06/02/2012
Last edited: 19/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-different-techniques-protect-heart-from-radiation-during-radiotherapy-breast-cancer-the-heartspare-study

Contact information

Dr Anna Kirby
Scientific

The Royal Marsden NHS Foundation Trust
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom

Email	anna.kirby@rmh.nhs.uk

Study information

Study design	Randomised non-blinded interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Optimisation and individualisation of heart-sparing breast radiotherapy techniques: a randomised controlled trial
Study objectives	Single-centre randomised, non-blinded crossover trials investigating the impact of different heart-sparing breast radiotherapy techniques upon normal-tissue doses and upon reproducibility of patient position in women undergoing breast radiotherapy following excision of early breast cancer. Hypotheses: 1. v_DIBH will be equivalent to ABC_DIBH in terms of dosimetric sparing of heart tissue, patient comfort, and set-up reproducibility, but at a reduced cost (due to the need for specialised equipment for ABC_DIBH) 2. Prone treatment is likely to be dosimetrically superior to optimal DIBH for the population of larger-breasted women 3. The optimal heart-sparing breast radiotherapy technique (DIBH versus prone positioning) will be individualisable to each patient based on their anatomical features More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11499
Ethics approval(s)	NRES Committee London Riverside, 25/01/2012, ref: 12/LO/0015
Health condition(s) or problem(s) studied	Breast cancer
Intervention	Study design: These are single-centre non-blinded randomised cross-over trials (RCT) comparing i) treatment in voluntary deep inspiartor breath-hold (v_DIBH) versus Active Breathing Control deep inspiratory breath-hold (ABC_DIBH) in women of all breast volumes (Group A), and ii) treatment in DIBH versus prone position in women with larger breast volumes (>750cm3) (Group B). Within each cohort, patients will be randomised to start with one technique and to cross over to the other after 7 fractions. Treatment planning: patient positioning and imaging: All patients will receive training in holding their breath comfortably for up to 20 seconds. They will then undergo two radiotherapy planning CT scans. Patients in Group A will receive one scan in ABC_DIBH and a second scan in v_DIBH. Patients in Group B will undergo one scan in optimal DIBH (as determined by results from Group A) and one on their front (prone). Treatment planning: study assessments: 1. 3D-CT planning scans in ABC_DIBH and v_DIBH (Group A) 2. 3D-CT planning scans in optimal DIBH and prone (Group B) 3. Scan times for each technique 4. Patient comfort and acceptability questionnaire following above scans Treatment planning: target volume definition and radiotherapy planning: Whole breast clinical target volume (WBCTV), contralateral breast tissue, lungs, heart, left anterior descending coronary artery (LAD) and ribcage will be outlined. For each technique, whole breast RT will be forward planned in 3D using multiple static opposed tangential fields, aiming to cover 90% of WBCTV with the 95% isodose, with hotspots ≥ 107cm3 limited to ≤ 2cm3. 40Gy in 15 fractions over 3 weeks will be prescribed to the 100% isodose (using 6-10MV photons). During radiotherapy course: summary of study assessments 1. Daily EPI including cine-loop 2. Low dose CT verification imaging 3. Treatment times 4. Patient comfort and acceptability questionnaire 5. Radiographer satisfaction questionnaire Follow-up assessments No further investigations are required as part of the study following completion of radiotherapy. No long-term trial-related follow-up is required, although patients will be reviewed in the breast clinic as part of their standard follow-up.
Intervention type	Other
Primary outcome measure	Group A: Reproducibility - interfraction reproducibility of patient position (mean daily displacements of chest wall) in v_DI
Secondary outcome measures	Group B: Difference in mean LAD NTDmean - difference in mean normal tissue dose (NTDmean) (Gy) to left anterior-descending coronary artery
Overall study start date	01/02/2012
Completion date	30/11/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned Sample Size: 73; UK Sample Size: 73; Description: Group A: 23 patients; Group B: 50 patients
Key inclusion criteria	1. Complete microscopic excision of early stage invasive ductal or lobular carcinoma (pT1-3b N0-1 M0) of the left breast following breast conservation surgery or mastectomy 2. Recommendation for whole breast (Group A and B) or chest wall radiotherapy (Group A only) (with or without tumour bed boost) 3. Age =18 4. Performance status =1 5. Patients able to tolerate breath-ho 6. Target Gender: Female 7. Lower Age Limit is 18 years
Key exclusion criteria	1. Requirement for nodal irradiaion 2. Patients with micro- or macro-scopic disease on sentinel node biopsy who have not undergone completion axillary node clearance 3. Previous radiotherapy to any region above the diaphragm
Date of first enrolment	01/02/2012
Date of final enrolment	30/11/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Royal Marsden NHS Foundation Trust

Surrey
SM2 5PT
United Kingdom

Sponsor information

The Royal Marsden Foundation Trust (UK)
Hospital/treatment centre

Institute of Cancer Research
Downs Road
Sutton
Surrey
SM2 5PT
England
United Kingdom

Website	http://www.royalmarsden.nhs.uk/
"ROR"	https://ror.org/0008wzh48

Funders

Funder type

Government

NIHR Research for Patient Benefit (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Results article	results	01/08/2013	Yes	No
Results article	results	01/01/2015	Yes	No

Editorial Notes

19/02/2020: Cancer Research UK lay results summary link added to Results (plain English).
29/02/2016: Publication references added.