Optimisation and individualisation of HeartSparing breast radiotherapy techniques (The HeartSpare Study): Stage II
| ISRCTN | ISRCTN62239447 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62239447 |
| Protocol serial number | 14269 |
| Sponsor | Royal Marsden NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Programme ref: PB-PG-1010-23003 |
- 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
Plain English summary of protocol
Contact information
Scientific
Downs Road
Sutton
SM2 5PT
United Kingdom
| Phone | +44 20 7352 8171 |
|---|---|
| frederick.bartlett@rmh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre non-randomised interventional trial; Design type: Treatment |
| Secondary study design | Non randomised study |
| Study type | Participant 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(s) |
Percentage of patients in whom a reduction in mean LAD dose (Gy) is achieved with v_DIBH measured at end of study |
| Key secondary outcome measure(s) |
1. Costs of techniques (equipment and time to scan/treat) measured at end of study |
| Completion date | 02/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 75 |
| 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
- United Kingdom
- England
Study participating centre
SM2 5PT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/01/2017: No publications found in PubMed, verifying study status with principal investigator.
