Optimisation and individualisation of HeartSparing breast radiotherapy techniques (The HeartSpare Study): Stage II

ISRCTN	ISRCTN62239447
DOI	https://doi.org/10.1186/ISRCTN62239447
Secondary identifying numbers	14269

Submission date: 24/04/2013
Registration date: 26/04/2013
Last edited: 06/01/2017

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Frederick Bartlett
Scientific

Downs Road
Sutton
SM2 5PT
United Kingdom

Phone	+44 20 7352 8171
Email	frederick.bartlett@rmh.nhs.uk

Study information

Study design	Multicentre non-randomised interventional trial; Design type: Treatment
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 below to request a patient information sheet
Scientific title	Optimisation and individualisation of HeartSparing breast radiotherapy techniques (The HeartSpare Study): Stage II multicentre, non-randomised intervention trial
Study acronym	The HeartSpare Study (Stage II)
Study objectives	A multicentre non-randomised intervention trial investigating whether the roll-out of voluntary deep-inspiratory breath-hold (v_DIBH) in the context of a HTA-funded multicentre trial of breast radiotherapy fractionation (the FAST-Forward trial http://www.controlled-trials.com/ISRCTN19906132) confirms effective heart-sparing in women undergoing breast radiotherapy following excision of early breast cancer.
Ethics approval(s)	NRES Committee London - Fulham, 18/02/2013, ref: 13/LO/0181
Health condition(s) or problem(s) studied	Breast cancer
Intervention	Radiotherapy using v_DIBH: Patients will receive their radiotherapy using the v_DIBH technique Study Entry : Registration only
Intervention type	Other
Primary outcome measure	Percentage of patients in whom a reduction in mean LAD dose (Gy) is achieved with v_DIBH measured at end of study
Secondary outcome measures	1. Costs of techniques (equipment and time to scan/treat) measured at end of study 2. Difference in mean doses (Gy) to heart, ipsilateral lung and whole lungs, and maximum LAD dose measured at end of study 3. Interfraction reproducibility of patient position measured at end of study 4. Patient and radiographer satisfaction with positioning technique (questionnaire) measured at end of study. 5. Proportion of patients in whom prone position would have been optimal measured at end of study 6. Time spent in various activities / stages of treatment planning and delivery measured at end of study
Overall study start date	03/06/2013
Completion date	02/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	UK Sample Size: 75; Description: 13 patients will be recruited from each of the five participating centres.
Key inclusion criteria	1. Women or men with left-sided breast cancer 2. Recommendation for whole breast or chest wall RT within FAST-Forward trial 3. Patients with any heart tissue in a tangential RT field placed according to standard anatomical borders 3. Any breast volume 4. Eastern Cooperative Oncology Group (ECOG) performance status <=1 5. Patients able to tolerate breath-hold
Key exclusion criteria	1. Right-sided breast cancer 2. Ineligible for whole breast or chest wall RT within FAST-Forward trial 3. Patients with micro- or macro-scopic disease on sentinel node biopsy who have not undergone completion axillary node clearance 4. Previous radiotherapy to any region above the diaphragm
Date of first enrolment	03/06/2013
Date of final enrolment	02/05/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Downs Road

Sutton
SM2 5PT
United Kingdom

Sponsor information

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

Downs Road
Sutton
SM2 5PT
England
United Kingdom

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

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Programme ref: PB-PG-1010-23003

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	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

06/01/2017: No publications found in PubMed, verifying study status with principal investigator.